Mild Cognitive ImpairmentNCT06252844
The Impact of 6-months of Resistance Training on Brain and Muscle Health in Older Adults With MCI
A study testing Resistance exercise training in people with Mild Cognitive Impairment and Older Adults at High Risk for MCI, run by Lithuanian Sports University at 2 sites in Lithuania.
Trial summary
The goal of this clinical trial is to learn about the effect of long resistance training intervention on brain and muscle health in older adults with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Older Adults at High Risk for MCI
- What is being tested?
- Resistance exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesLithuania
- Study dates
- 15 Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male and female 65+ years old,
- Community-dwelling,
- Sedentary (not engaged in any structured activity for exercise) or non-sedentary individuals who engaged in mild recreational activities for less than 150 min/week.
- A score of 18 to 25 on the Montreal Cognitive Assessment (MoCA) with or without a diagnosis of MCI. The diagnosis of MCI will be confirmed by a qualified mental health care specialist at the screening evaluation according to the International Classification of Diseases (ICD-10) and the Petersen criteria (Petersen et al, 2014).
- Fluent in Lithuanian.
Who cannot join
- Age < 65 years.
- MoCA ≥ 26 or MoCA < 18,
- Symptomatic heart or cardiopulmonary disorders, diabetes, diagnosis of renal/hepatic disease, oncology, brain injury, diagnosis of neurologic, psychiatric, or musculoskeletal diseases.
- Physical or orthopedic conditions (rheumatic symptoms, chronic pain, fractures, acute muscle injuries) that limit the subject's ability to participate in the training program.
- Moderate to severe intake of alcohol (intake of 3 drinks or more/day for men and 2 drink or more/day for women).
- Current smoker
Show all 10Show fewer
- Intake of drugs or psychiatric medications.
- Contraindications to perform MRI (e.g., claustrophobia, cardiac pacemaker, internal pacing wires, metal implants, etc.).
- Body mass index (BMI) > 35 kg/m2 or body weight > 130 kg.
- Participation in routine exercise or physical activities (IPAQ).
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites, 2 recruiting
- Recruiting
Institute of Sport Science and Innovations
Kaunas
Nerijus Masiulis, PhD, +370 60039099, nerijus.masiulis@lsu.lt
Oron Levin, PhD
- Recruiting
Lithuanian Sports University
Kaunas
Vilma Dudoniene, PhD
About this study
Official title: The Impact of 6-months of Resistance Training on Intrinsic Capacity, Cognition, and Brain/Circulating Biomarkers of Neuroplasticity and Neuroinflammation in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Trial.
The goal of this clinical trial is to learn about the effect of long resistance training intervention on brain and muscle health in older adults with mild cognitive impairment (MCI). The main question it aims to answer is whether progressive resistance training can prevent/delay neurodegenerative/pro-inflammatory processes that are detrimental to cognition, mobility, vitality, and mental health of older adults with MCI. Participants will undergo 6 months of supervise resistance training. Subjects in the intervention group will undergo sessions of structural and functional magnetic resonance imaging, proton magnetic resonance spectroscopy at baseline and end of intervention. Blood analyses and functional and cognitive tests will be performed at baseline after 3 months from the start of intervention and at the end of the intervention. Observations obtained from the intervention group will compare to data collected from age-matched active control group who will undergo flexibility training of lower limb muscles.
Read the detailed description
Physical exercise appears to be effective in preventing transitions from normal cognitive aging to mild cognitive impairments (MCI) and from MCI to dementia-related disorders such as Alzheimer's disease (AD). The investigators will examine the longitudinal effects of progressive resistance training on biomarkers of (neuro)inflammation and neuroplasticity in a cohort of community-dwelling older individuals at high risk of developing MCI. The investigators will focus specifically on the effects of 24 weeks of resistance training on structural and neurochemical properties of the hippocampus and associations between exercise-induced changes in those properties and improvement in functional ability as quantified by pre-to-post changes in the mobility, cognition, psychological and vitality composites of intrinsic capacity (IC). Similarly, the investigators will examine the association between exercise-induced changes in global internal capacity index and exercise-induced changes in the expressions of inflammatory biomarkers (specifically, IL-1β, IL-6, IL-10, IL-18, kynurenine, and TNFa), myokines (specifically, BDNF, IGF-1, irisin), and circulating biomarkers of neurodegeneration (specifically, neurofilament light chain - NfL), tauopathy (specifically, total and phosphorylated tau181) and amyloid pathology (specifically, Aβ42/Aβ40 ratio). Blood samples will be collected between 8 a.m. and 11 a.m. after fasting. Behavioral outcome measures from gait/balance tests, handgrip strength test, cognitive tests, psychological tests, etc. and serum/plasma levels of the circulating biomarkers will be assessed at baseline, mid-intervention time (12 weeks), immediately post-intervention time (24 weeks), and at six-month follow-up (48 weeks). Structural MRI (sMRI) images, diffusion MRI (dMRI) images, resting state functional MRI (rs-fMRI) data and proton magnetic resonance spectroscopy (1H-MRS) data from the brain and T1-wighted images and 1H-MRS spectra from the lower-limb musculature will be collected at baseline and immediately post-treatment time (24 weeks) using a Siemens 3T Skyra scanner. Findings from this study will be used to provide evidence-based frameworks for implementation of longitudinal exercise interventions in prevention of dementia-related neurodegenerative disease among older with MCI. Further, the investigators will assess the effects of exercise on longitudinal changes in muscle mass, muscle strength, and neuromuscular functioning and examine the associations between these changes and exercise induced changes in locomotion capacity and postural stability as well as the prevention of sarcopenia and frailty. Secondary (exploratory) outcome measures will be (1) effects of the longitudinal strength training program on brain structural and neurochemical properties and (2) demographic factors, physiological properties and/or biomarkers that predict response to the intervention.
- Being tested
- Resistance exercise training, Active control
- Keywords
- Mild Cognitive Impairment, Magnetic resonance imaging, Proton magnetic resonance spectroscopy (1H-MRS), Intrinsic capacity, Mobility, Blood biomarkers, cytokines, Neuroinflammation, Systemic inflammation, Neurometabolites
- Medical subject headings
- Cognitive Dysfunction, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingBehavioural
Supervised PRT will consist of leg extension, leg curl, leg press, and calf raises. Initially participants will start with a 4 weeks adaptation with low loads at 15 (repetition maximum, RM) conducting for 1-3 sets. Further on subjects will continue with a 5 month of PRT with intensity increasing every 2 weeks from 12 to 6 RM. Each exercise will be done for 3 sets with 2 min rest periods between sets. After the 2 weeks at 6 RM, 1 week of rest will be applied. After the rest week, the same cycle starting from 12 RM will be repeated until the end of intervention.
Active controlBehavioural
Supervised static stretching exercises will be performed without causing an unpleasant feeling of stretching, up to pain, maintaining the stretching position for at least 30 s. Exercises will be performed slowly so that heart rate (HR) does not exceed 50% maximum. Subjects will calculate their HR before training, in the middle and after the training measuring the pulse for 10 s. Exercises will be repeated 3-5 times for each side of the body. The duration of the training will be match to PRT group and will take around 40 min. In order to keep the subjects interested and motivated, two of the stretching exercises will be changed every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Progressive resistance training (PRT) of lower limb muscles. Frequency of intervention: 2-3 times per week. Duration of intervention: 24 weeks. Receives: Behavioral: Resistance exercise training |
| Active control | Experimental | Flexibility training of the lower limb muscles. Frequency of intervention: 2-3 times per week. Duration of intervention: 24 weeks. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intrinsic capacity
Assessment of intrinsic capacity subdomains will be conducted according to the WHO ICOPE guidelines.
Outcome measures:
Locomotion capacity [scale 0 to 12] with higher scores indicating a better outcome.
Cognition capacity [scale: 0 to 4], with higher scores indicating a better outcome.
Psychological capacity (mood) [scale: 0 to 4] with higher scores indicating a better outcome.
Vitality [scale 0 to 12], with higher scores indicating a better outcome. Sensory capacity index [scale 0 to 3], with higher scores indicating a better outcome.
Capacity indexes for each of the above mentioned subdomains will be calculated as the scores obtained divided by the maximum possible scores [scale 0 to 1].
The global intrinsic capacity index will be calculated as the sum of the subdomain's capacity indexes [scale 0 to 5] with higher scores indicating a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in global cognition
Outcome measure: scores on the Montreal cognitive assessment (MoCA) [range 0 - 30] with higher scores indicating better performance.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in psychological assessment of depression
Outcome measure: scores on the Geriatric depression scale (GDS), [range 0-15] with higher score indicate severe depression.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in reaction time
ANAM4 cognitive test battery, including:
Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT)
Outcome measures: Reaction Time (in milliseconds) with shorter time indicating a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in reaction accuracy
ANAM4 cognitive test battery, including:
Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT)
Outcome measures: % number of correct responses with higher value indicating a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in cognitive efficiency
ANAM4 cognitive test battery, including:
Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT)
Outcome measures: throughput (= number of correct responses divided by mean RT for correct responses) with higher value indicating a better outcome
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in Stroop interference score
Stroop Color and Word test (SCWT)
Outcome measure:
interference score (in seconds) Interference = CWT - [(WT + CT)/2] where WT, CT, and CWT are times (in seconds) to complete the Word, Color, and Color-Word conditions, respectively. Lower interference score indicates a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in performance on the Trail Making Test (TMT)
Complete parts A and part B of the Trail Making Test
Outcome measures:
Time (in seconds) required to complete part A (Trail A scores) Time (in seconds) required to complete part B (Trail B scores) Shorter time indicated a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in sway velocity
Center of pressure (CoP) data will be collected in stance position with a single piezoelectric force plate (KISTLER, model 9286) under single and dual-task condition.
Outcome measures:
CoP sway velocity (CoPv) in ML and AP sway directions (millimiter/seconds). Lower sway velocity represents a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in dual-task cost for sway velocity
Dual task cost (DTC) will be quantified as % change of sway velocity from dual to single task relative to their single task values.
Increased negative value represents a better outcome whereas increased positive value represents a worse outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in agility
8-Foot timed up and go (8-foot TUG): Outcome measure: time to complete the task in seconds. Shorter time to complete the task represents a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in lower body strength and muscular endurance
30s Chair-Rise test: Outcome measure: number of sit-to-stand repetitions completed in 30 seconds. More sit-to-stand repetitions represents a better outcome.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in levels of Albumin (Alb)
Albumin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in levels of Hemoglobin (Hb)
Hemoglobin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in levels of C-reactive protein (CRP)
CRP levels [milligrams/deciliter (mg/dL)] will be measured with COBAS PRO blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of cytokines
Serum levels of the interleukins IL-1β, IL-6, IL-10, IL-18 and serum levels of TNFα [all picograms/milliliter(pg/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of Kynurenine
Serum levels of Kynurenine [nanograms/milliliter(ng/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of brain-derived neurotrophic factor (BDNF)
Plasma levels of BDNF [picograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of Insulin-like growth factor 1 (IGF-1)
Serum levels of IGF-1 [nanograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of Irisin
Plasma levels of irisin [nanograms/milliliter (ng/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of c-terminal agrin fragment-22 (CAF22)
Serum levels of c-terminal agrin fragment-22 [picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of Neurofilament light chain (NfL)
Plasma levels of NfL (picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of tau proteins
Plasma levels of phosphorylated tau181 (p-tau181) and total tau (t-tau) [both, picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the at antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in circulating levels of beta amyloids
Plasma levels of beta amyloid 40 (Aβ40) and beta amyloid 42 (Aβ42) will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis. Plasma levels of Aβ40 and Aβ42 will be combined to calculate the Aβ42/40 ratio.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in brain volume properties
Whole brain T1-weighted images, T2-wighted images, T2* relaxation images and fluid attenuated inversion recovery (FLAIR) images will be obtained. Outcome measures will be grey matter (GM) volumes, white matter (WM) volumes (WM) and WM hyperintensity (WMH) volumes [all in cubic millimeter (mm^3)] of cortical and subcortical structures. A total WMH volume will be obtained by summing the volumes of hyperintensities from all of the substructures. A large WMH volume will be taken as an indicator for cerebrovascular abnormalities. Image processing: FreeSurfaer software, version 6 (freely available).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in brain cortical thickness
Whole brain T1-weighted images. Outcome measures: GM cortical thicknesses (in mm) of cortical substructures. Image processing: FreeSurfer software, version 6 (freely available).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in brain WM microstructural organization
Participants will undergo whole brain diffusion-weighted imaging (DWI). Outcome measures will be the Fractional anisotropy (FA) of WM tracts in the brain. Image processing will be possible with the use of the ExploreDTI software (freely available).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in brain neurometabolic levels
Single voxel proton magnetic resonance spectroscopy (1H-MRS) of left hippocampus (HPC), right dorsolateral prefrontal cortex (dlPFC) and left sensory motor cortex (SM1). Data will be processed with LC Model within the Osprey pipeline (freely available).
Outcome measures will be the water-referenced levels of:
- N-acetyl aspartate (NAA),
- Creatine (Cr),
- Choline (Cho),
- Myoinositol (mIns),
- Glutamine-glutamate complex (Glx),
All levels are expressed in institutional units (i.u).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in brain neurometabolic ratios
Single voxel proton magnetic resonance spectroscopy (1H-MRS). Ratios will be calculated from water-referenced levels of NAA, Cho, mIns, Glx, and Cr in left Hippocampus, left sensorimotor cortex and right dorsolateral prefrontal cortex.
Outcome measures:
- NAA/Cr,
- Cho/Cr,
- mIns/Cr,
- Glx/Cr
- NAA/mIns
Ratios are expressed in arbitrary units (a.u).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in quadriceps/hamstrings cross sectional area
T1-weighted images of the left/right thighs
Outcome measures:
- Quadricepscross-sectional areas at mid-thigh (in cm^2)
- Hamstring cross-sectional areas at mid-thigh (in cm^2).
Measured: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in quadriceps myocellular lipid content
1H-MRS spectra from the right quadriceps.
Outcome measures:
- Quadriceps intramyocellular lipid (IMCL) content (% of unsuppressed water signal area)
- Quadriceps extramyocellular lipid (EMCL) content (% of unsuppressed water signal area).
- Quadriceps total IMCL and EMCL content (% of unsuppressed water signal area)
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in body composition and BMI
TANITA body impedance analysis. Outcome measures: total body weight, body fat mass, lean muscle mass, and bone mass (in kilograms).
Total body weight and fat weight will be combined to calculate % body fat. Total body weight and height will be combined to calculate the body mass index (BMI) in kilograms/meter^2.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in knee muscle torque production
Biodex
- Maximum voluntary contraction (MVC) torque during isometric contraction in Newton/meter (N/m).,
- Knee extension/flexion concentric isokinetic peak torques (PT) in N/m at isokinetic speed of 60 and 180 deg/s.
- Torque development in N/m at 30ms, 50 ms, 100 ms, and 200 ms from onset of contraction.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in muscle contraction time
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads.
Outcome measures:
Delay time (Td) and contraction time (Tc) of left/right RF and BF (in milliseconds).
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in muscle contraction displacement
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads.
Outcome measures:
Muscle contraction displacement (Dm) of left/right RF and BF (in millimeter).
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in muscle contraction velocity
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads.
Muscle contraction displacement (Dm), delay time (Td) and contraction time (Tc) will be combined to calculate contraction velocity (Vc) of left/right RF and BF.
Vc = [Dm/(Td +Tc)] (in millimeter/second).
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in level of fatigue
Participants will complete the Multidimensional Fatigue Inventory (MFI-20) [range 4-20] with higher scores indicate a higher level of fatigue.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in level of frailty
Subjects will undergo the Edmonton Frail Scale survey [range 0 -17] with higher scores indicate a higher level of frailty.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in health status
Participants will complete the 36-Items Form Health survey (SF-36), [range 0-100] with higher score indicate better physical and mental health.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in nutritional status
Participants will complete the Mini Nutritional Assessment (MNA) survey [range 0-14] with higher score indicate better nutritional condition.
Measured: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Secondary outcomes (4)
Changes in blood count
Blood count tests will be conducted using GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Outcome measures:
- Red blood cell count measured in cells per liter (cells/L). Normal range [Male: 4.35 x 10^12 to 5.65 x 10^12 cells/L; Female: 3.92 x 10^12 to 5.13 x 10^12 cells/L].
- White blood cell count measured in cells per liter (cells/L). Normal range [3.4 x 10^9 to 9.6 x 10^9 cells/L].
- Platelet count measured in cells per liter (cells/L). Normal range [Male: 135 x 10^9 to 317 10^9 cells/L; Female: 157 x 10^9 to 371x10^9 cells/L].
- Hematocrit (percentage by volume of red cells). Normal range [Male: 38.3% to 48.6%; Female: 35.5% to 44.9%].
Measured: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in lipid profiles
A lipidogram test will be conducted using COBAS PRO blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Outcome measures:
- Level of HDL (high-density lipoprotein) cholesterol [millimole/liter (mmol/L)]. Normal range < 1.68 mmol/L
- Level of LDL (high-density lipoprotein) cholesterol. Normal range < 2.59 mmol/L.
- Level of total cholesterol. Normal range < 5.2 mmol/L
- Level of Triglycerides. Normal range < 1.7 mmol/L
Measured: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in Glycosylated Hemoglobin (HbA1c)
Glycosylated Hemoglobin levels will be measured using the Alinity C method. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Outcome measures:
- Level of HbA1c [millimole/liter (mmol/L)]. Normal range < 42 mmol/L (~ 6%).
Measured: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Self-report measure of habitual physical activity
Participants will complete the International Physical Activity Questionnaire (IPAQ-LT). Higher score indicate high physical activity level.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, KU Leuven, Vrije Universiteit Brussel, Wingate Institute, University of Hamburg-Eppendorf, Maastricht University
- Responsible party
- Principal investigator, Vilma Dudoniene, Lithuanian Sports University
- Investigators
- Oron Levin, PhD, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252844
- Sponsor's protocol ID
- LithuanianSportsU-18
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. The data collected in this study will be available to all collaborators in an interactive closed data repository. 2. Analyzed data will be available in an open-source data repository for all researchers upon request after the end of the study.
Publications
Bautmans I, Knoop V, Amuthavalli Thiyagarajan J, Maier AB, Beard JR, Freiberger E, Belsky D, Aubertin-Leheudre M, Mikton C, Cesari M, Sumi Y, Diaz T, Banerjee A; WHO Working Group on Vitality Capacity. WHO working definition of vitality capacity for healthy longevity monitoring. Lancet Healthy Longev. 2022 Nov;3(11):e789-e796. doi: 10.1016/S2666-7568(22)00200-8.
PubMed 36356628Beard JR, Si Y, Liu Z, Chenoweth L, Hanewald K. Intrinsic Capacity: Validation of a New WHO Concept for Healthy Aging in a Longitudinal Chinese Study. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):94-100. doi: 10.1093/gerona/glab226.
PubMed 34343305Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.
PubMed 31275941Cesari M, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Cooper C, Martin FC, Reginster JY, Vellas B, Beard JR. Evidence for the Domains Supporting the Construct of Intrinsic Capacity. J Gerontol A Biol Sci Med Sci. 2018 Nov 10;73(12):1653-1660. doi: 10.1093/gerona/gly011.
PubMed 29408961Cesari M, Sadana R, Sumi Y, Amuthavalli Thiyagarajan J, Banerjee A. What Is Intrinsic Capacity and Why Should Nutrition Be Included in the Vitality Domain? J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):91-93. doi: 10.1093/gerona/glab318. No abstract available.
PubMed 35015816De Luca A, Kuijf H, Exalto L, Thiebaut de Schotten M, Biessels GJ; Utrecht VCI Study Group. Multimodal tract-based MRI metrics outperform whole brain markers in determining cognitive impact of small vessel disease-related brain injury. Brain Struct Funct. 2022 Sep;227(7):2553-2567. doi: 10.1007/s00429-022-02546-2. Epub 2022 Aug 22.
PubMed 35994115Gallardo-Gomez D, Del Pozo-Cruz J, Noetel M, Alvarez-Barbosa F, Alfonso-Rosa RM, Del Pozo Cruz B. Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022 Apr;76:101591. doi: 10.1016/j.arr.2022.101591. Epub 2022 Feb 17.
PubMed 35182742Leung AYM, Su JJ, Lee ESH, Fung JTS, Molassiotis A. Intrinsic capacity of older people in the community using WHO Integrated Care for Older People (ICOPE) framework: a cross-sectional study. BMC Geriatr. 2022 Apr 8;22(1):304. doi: 10.1186/s12877-022-02980-1.
PubMed 35395736Levin O, Netz Y, Ziv G. The beneficial effects of different types of exercise interventions on motor and cognitive functions in older age: a systematic review. Eur Rev Aging Phys Act. 2017 Dec 21;14:20. doi: 10.1186/s11556-017-0189-z. eCollection 2017.
PubMed 29276545Levin O, Vints WAJ, Ziv G, Katkute G, Kusleikiene S, Valatkeviciene K, Sheoran S, Drozdova-Statkeviciene M, Gleizniene R, Paasuke M, Dudoniene V, Himmelreich U, Cesnaitiene VJ, Masiulis N. Neurometabolic correlates of posturography in normal aging and older adults with mild cognitive impairment: Evidence from a 1H-MRS study. Neuroimage Clin. 2023;37:103304. doi: 10.1016/j.nicl.2022.103304. Epub 2022 Dec 24.
PubMed 36580713Netz Y. Is There a Preferred Mode of Exercise for Cognition Enhancement in Older Age?-A Narrative Review. Front Med (Lausanne). 2019 Mar 29;6:57. doi: 10.3389/fmed.2019.00057. eCollection 2019.
PubMed 30984760Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
PubMed 24605806Sheoran S, Vints WAJ, Valatkeviciene K, Kusleikiene S, Gleizniene R, Cesnaitiene VJ, Himmelreich U, Levin O, Masiulis N. Strength gains after 12 weeks of resistance training correlate with neurochemical markers of brain health in older adults: a randomized control 1H-MRS study. Geroscience. 2023 Jun;45(3):1837-1855. doi: 10.1007/s11357-023-00732-6. Epub 2023 Jan 26.
PubMed 36701005Tatebe H, Kasai T, Ohmichi T, Kishi Y, Kakeya T, Waragai M, Kondo M, Allsop D, Tokuda T. Quantification of plasma phosphorylated tau to use as a biomarker for brain Alzheimer pathology: pilot case-control studies including patients with Alzheimer's disease and down syndrome. Mol Neurodegener. 2017 Sep 4;12(1):63. doi: 10.1186/s13024-017-0206-8.
PubMed 28866979Vints WAJ, Gokce E, Langeard A, Pavlova I, Cevik OS, Ziaaldini MM, Todri J, Lena O, Sakkas GK, Jak S, Zorba Zormpa I, Karatzaferi C, Levin O, Masiulis N, Netz Y. Myokines as mediators of exercise-induced cognitive changes in older adults: protocol for a comprehensive living systematic review and meta-analysis. Front Aging Neurosci. 2023 Jul 13;15:1213057. doi: 10.3389/fnagi.2023.1213057. eCollection 2023.
PubMed 37520128
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 6-months of Resistance Training on Intrinsic Capacity, Cognition, and Brain/Circulating Biomarkers of Neuroplasticity and Neuroinflammation in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06252844
- Acronym / sponsor ID
- LithuanianSportsU-18
- Keywords
- Mild Cognitive Impairment, Magnetic resonance imaging, Proton magnetic resonance spectroscopy (1H-MRS), Intrinsic capacity, Mobility, Blood biomarkers, cytokines, Neuroinflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Collaborators
- Lithuanian University of Health Sciences, KU Leuven, Vrije Universiteit Brussel, Wingate Institute, University of Hamburg-Eppendorf, Maastricht University
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the effect of long resistance training intervention on brain and muscle health in older adults with mild cognitive impairment (MCI). The main question it aims to answer is whether progressive resistance training can prevent/delay neurodegenerative/pro-inflammatory processes that are detrimental to cognition, mobility, vitality, and mental health of older adults with MCI. Participants will undergo 6 months of supervise resistance training. Subjects in the intervention group will undergo sessions of structural and functional magnetic resonance imaging, proton magnetic resonance spectroscopy at baseline and end of intervention. Blood analyses and functional and cognitive tests will be performed at baseline after 3 months from the start of intervention and at the end of the intervention. Observations obtained from the intervention group will compare to data collected from age-matched active control group who will undergo flexibility training of lower limb muscles.
Detailed description
Physical exercise appears to be effective in preventing transitions from normal cognitive aging to mild cognitive impairments (MCI) and from MCI to dementia-related disorders such as Alzheimer's disease (AD). The investigators will examine the longitudinal effects of progressive resistance training on biomarkers of (neuro)inflammation and neuroplasticity in a cohort of community-dwelling older individuals at high risk of developing MCI. The investigators will focus specifically on the effects of 24 weeks of resistance training on structural and neurochemical properties of the hippocampus and associations between exercise-induced changes in those properties and improvement in functional ability as quantified by pre-to-post changes in the mobility, cognition, psychological and vitality composites of intrinsic capacity (IC). Similarly, the investigators will examine the association between exercise-induced changes in global internal capacity index and exercise-induced changes in the expressions of inflammatory biomarkers (specifically, IL-1β, IL-6, IL-10, IL-18, kynurenine, and TNFa), myokines (specifically, BDNF, IGF-1, irisin), and circulating biomarkers of neurodegeneration (specifically, neurofilament light chain - NfL), tauopathy (specifically, total and phosphorylated tau181) and amyloid pathology (specifically, Aβ42/Aβ40 ratio). Blood samples will be collected between 8 a.m. and 11 a.m. after fasting. Behavioral outcome measures from gait/balance tests, handgrip strength test, cognitive tests, psychological tests, etc. and serum/plasma levels of the circulating biomarkers will be assessed at baseline, mid-intervention time (12 weeks), immediately post-intervention time (24 weeks), and at six-month follow-up (48 weeks). Structural MRI (sMRI) images, diffusion MRI (dMRI) images, resting state functional MRI (rs-fMRI) data and proton magnetic resonance spectroscopy (1H-MRS) data from the brain and T1-wighted images and 1H-MRS spectra from the lower-limb musculature will be collected at baseline and immediately post-treatment time (24 weeks) using a Siemens 3T Skyra scanner. Findings from this study will be used to provide evidence-based frameworks for implementation of longitudinal exercise interventions in prevention of dementia-related neurodegenerative disease among older with MCI. Further, the investigators will assess the effects of exercise on longitudinal changes in muscle mass, muscle strength, and neuromuscular functioning and examine the associations between these changes and exercise induced changes in locomotion capacity and postural stability as well as the prevention of sarcopenia and frailty. Secondary (exploratory) outcome measures will be (1) effects of the longitudinal strength training program on brain structural and neurochemical properties and (2) demographic factors, physiological properties and/or biomarkers that predict response to the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Resistance exercise trainingProgressive resistance training (PRT) of lower limb muscles. Frequency of intervention: 2-3 times per week. Duration of intervention: 24 weeks. |
| Active control | Experimental | Behavioral: Active controlFlexibility training of the lower limb muscles. Frequency of intervention: 2-3 times per week. Duration of intervention: 24 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male and female 65+ years old,
- Community-dwelling,
- Sedentary (not engaged in any structured activity for exercise) or non-sedentary individuals who engaged in mild recreational activities for less than 150 min/week.
- A score of 18 to 25 on the Montreal Cognitive Assessment (MoCA) with or without a diagnosis of MCI. The diagnosis of MCI will be confirmed by a qualified mental health care specialist at the screening evaluation according to the International Classification of Diseases (ICD-10) and the Petersen criteria (Petersen et al, 2014).
- Fluent in Lithuanian.
Key exclusion criteria (10 listed)
- Age < 65 years.
- MoCA ≥ 26 or MoCA < 18,
- Symptomatic heart or cardiopulmonary disorders, diabetes, diagnosis of renal/hepatic disease, oncology, brain injury, diagnosis of neurologic, psychiatric, or musculoskeletal diseases.
- Physical or orthopedic conditions (rheumatic symptoms, chronic pain, fractures, acute muscle injuries) that limit the subject's ability to participate in the training program.
- Moderate to severe intake of alcohol (intake of 3 drinks or more/day for men and 2 drink or more/day for women).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise trainingSupervised PRT will consist of leg extension, leg curl, leg press, and calf raises. Initially participants will start with a 4 weeks adaptation with low loads at 15 (repetition maximum, RM) conducting for 1-3 sets. Further on subjects will continue with a 5 month of PRT with intensity increasing every 2 weeks from 12 to 6 RM. Each exercise will be done for 3 sets with 2 min rest periods between sets. After the 2 weeks at 6 RM, 1 week of rest will be applied. After the rest week, the same cycle starting from 12 RM will be repeated until the end of intervention. | Behavioural | Intervention |
| Active controlSupervised static stretching exercises will be performed without causing an unpleasant feeling of stretching, up to pain, maintaining the stretching position for at least 30 s. Exercises will be performed slowly so that heart rate (HR) does not exceed 50% maximum. Subjects will calculate their HR before training, in the middle and after the training measuring the pulse for 10 s. Exercises will be repeated 3-5 times for each side of the body. The duration of the training will be match to PRT group and will take around 40 min. In order to keep the subjects interested and motivated, two of the stretching exercises will be changed every two weeks. | Behavioural | Active control |
Primary outcome
Changes in intrinsic capacity
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Assessment of intrinsic capacity subdomains will be conducted according to the WHO ICOPE guidelines. Outcome measures: Locomotion capacity [scale 0 to 12] with higher scores indicating a better outcome. Cognition capacity [scale: 0 to 4], with higher scores indicating a better outcome. Psychological capacity (mood) [scale: 0 to 4] with higher scores indicating a better outcome. Vitality [scale 0 to 12], with higher scores indicating a better outcome. Sensory capacity index [scale 0 to 3], with higher scores indicating a better outcome. Capacity indexes for each of the above mentioned subdomains will be calculated as the scores obtained divided by the maximum possible scores [scale 0 to 1]. The global intrinsic capacity index will be calculated as the sum of the subdomain's capacity indexes [scale 0 to 5] with higher scores indicating a better outcome.
Changes in global cognition
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Outcome measure: scores on the Montreal cognitive assessment (MoCA) [range 0 - 30] with higher scores indicating better performance.
Changes in psychological assessment of depression
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Outcome measure: scores on the Geriatric depression scale (GDS), [range 0-15] with higher score indicate severe depression.
Changes in reaction time
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: Reaction Time (in milliseconds) with shorter time indicating a better outcome.
Changes in reaction accuracy
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: % number of correct responses with higher value indicating a better outcome.
Changes in cognitive efficiency
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
ANAM4 cognitive test battery, including: Go/No-Go test (GNG), 6 Letter Memory Search test (6LMST), Manikin test (MNKT) Outcome measures: throughput (= number of correct responses divided by mean RT for correct responses) with higher value indicating a better outcome
Changes in Stroop interference score
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Stroop Color and Word test (SCWT) Outcome measure: interference score (in seconds) Interference = CWT - [(WT + CT)/2] where WT, CT, and CWT are times (in seconds) to complete the Word, Color, and Color-Word conditions, respectively. Lower interference score indicates a better outcome.
Changes in performance on the Trail Making Test (TMT)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Complete parts A and part B of the Trail Making Test Outcome measures: Time (in seconds) required to complete part A (Trail A scores) Time (in seconds) required to complete part B (Trail B scores) Shorter time indicated a better outcome.
Changes in sway velocity
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Center of pressure (CoP) data will be collected in stance position with a single piezoelectric force plate (KISTLER, model 9286) under single and dual-task condition. Outcome measures: CoP sway velocity (CoPv) in ML and AP sway directions (millimiter/seconds). Lower sway velocity represents a better outcome.
Changes in dual-task cost for sway velocity
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Dual task cost (DTC) will be quantified as % change of sway velocity from dual to single task relative to their single task values. Increased negative value represents a better outcome whereas increased positive value represents a worse outcome.
Changes in agility
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
8-Foot timed up and go (8-foot TUG): Outcome measure: time to complete the task in seconds. Shorter time to complete the task represents a better outcome.
Changes in lower body strength and muscular endurance
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
30s Chair-Rise test: Outcome measure: number of sit-to-stand repetitions completed in 30 seconds. More sit-to-stand repetitions represents a better outcome.
Changes in levels of Albumin (Alb)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Albumin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Changes in levels of Hemoglobin (Hb)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Hemoglobin levels [grams/deciliter (g/dL)] will be measured with GBC-system XN-1500 blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Changes in levels of C-reactive protein (CRP)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
CRP levels [milligrams/deciliter (mg/dL)] will be measured with COBAS PRO blood analyzer. Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional.
Changes in circulating levels of cytokines
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Serum levels of the interleukins IL-1β, IL-6, IL-10, IL-18 and serum levels of TNFα [all picograms/milliliter(pg/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of Kynurenine
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Serum levels of Kynurenine [nanograms/milliliter(ng/ml)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of brain-derived neurotrophic factor (BDNF)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Plasma levels of BDNF [picograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of Insulin-like growth factor 1 (IGF-1)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Serum levels of IGF-1 [nanograms/milliliter(pg/mL)] will be assessed with enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of Irisin
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Plasma levels of irisin [nanograms/milliliter (ng/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of c-terminal agrin fragment-22 (CAF22)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Serum levels of c-terminal agrin fragment-22 [picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Serum samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of Neurofilament light chain (NfL)
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Plasma levels of NfL (picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of tau proteins
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Plasma levels of phosphorylated tau181 (p-tau181) and total tau (t-tau) [both, picograms/milliliter (pg/ml)] will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the at antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis.
Changes in circulating levels of beta amyloids
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Plasma levels of beta amyloid 40 (Aβ40) and beta amyloid 42 (Aβ42) will be assessed using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at the antecubital vein after 12-h fasting by a qualified medical professional. Plasma samples will be stored in the refrigerator compartment of the laboratory of the Lithuanian Sports University at -80 degrees Celsius until further analysis. Plasma levels of Aβ40 and Aβ42 will be combined to calculate the Aβ42/40 ratio.
Changes in brain volume properties
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Whole brain T1-weighted images, T2-wighted images, T2* relaxation images and fluid attenuated inversion recovery (FLAIR) images will be obtained. Outcome measures will be grey matter (GM) volumes, white matter (WM) volumes (WM) and WM hyperintensity (WMH) volumes [all in cubic millimeter (mm^3)] of cortical and subcortical structures. A total WMH volume will be obtained by summing the volumes of hyperintensities from all of the substructures. A large WMH volume will be taken as an indicator for cerebrovascular abnormalities. Image processing: FreeSurfaer software, version 6 (freely available).
Changes in brain cortical thickness
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Whole brain T1-weighted images. Outcome measures: GM cortical thicknesses (in mm) of cortical substructures. Image processing: FreeSurfer software, version 6 (freely available).
Changes in brain WM microstructural organization
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Participants will undergo whole brain diffusion-weighted imaging (DWI). Outcome measures will be the Fractional anisotropy (FA) of WM tracts in the brain. Image processing will be possible with the use of the ExploreDTI software (freely available).
Changes in brain neurometabolic levels
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Single voxel proton magnetic resonance spectroscopy (1H-MRS) of left hippocampus (HPC), right dorsolateral prefrontal cortex (dlPFC) and left sensory motor cortex (SM1). Data will be processed with LC Model within the Osprey pipeline (freely available). Outcome measures will be the water-referenced levels of: * N-acetyl aspartate (NAA), * Creatine (Cr), * Choline (Cho), * Myoinositol (mIns), * Glutamine-glutamate complex (Glx), All levels are expressed in institutional units (i.u).
Changes in brain neurometabolic ratios
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Single voxel proton magnetic resonance spectroscopy (1H-MRS). Ratios will be calculated from water-referenced levels of NAA, Cho, mIns, Glx, and Cr in left Hippocampus, left sensorimotor cortex and right dorsolateral prefrontal cortex. Outcome measures: * NAA/Cr, * Cho/Cr, * mIns/Cr, * Glx/Cr * NAA/mIns Ratios are expressed in arbitrary units (a.u).
Changes in quadriceps/hamstrings cross sectional area
Time frame: Baseline and Post-intervention time (24 weeks); Optional: follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
T1-weighted images of the left/right thighs Outcome measures: * Quadricepscross-sectional areas at mid-thigh (in cm^2) * Hamstring cross-sectional areas at mid-thigh (in cm^2).
Changes in quadriceps myocellular lipid content
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
1H-MRS spectra from the right quadriceps. Outcome measures: * Quadriceps intramyocellular lipid (IMCL) content (% of unsuppressed water signal area) * Quadriceps extramyocellular lipid (EMCL) content (% of unsuppressed water signal area). * Quadriceps total IMCL and EMCL content (% of unsuppressed water signal area)
Changes in body composition and BMI
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
TANITA body impedance analysis. Outcome measures: total body weight, body fat mass, lean muscle mass, and bone mass (in kilograms). Total body weight and fat weight will be combined to calculate % body fat. Total body weight and height will be combined to calculate the body mass index (BMI) in kilograms/meter^2.
Changes in knee muscle torque production
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Biodex * Maximum voluntary contraction (MVC) torque during isometric contraction in Newton/meter (N/m)., * Knee extension/flexion concentric isokinetic peak torques (PT) in N/m at isokinetic speed of 60 and 180 deg/s. * Torque development in N/m at 30ms, 50 ms, 100 ms, and 200 ms from onset of contraction.
Changes in muscle contraction time
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Outcome measures: Delay time (Td) and contraction time (Tc) of left/right RF and BF (in milliseconds).
Changes in muscle contraction displacement
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Outcome measures: Muscle contraction displacement (Dm) of left/right RF and BF (in millimeter).
Changes in muscle contraction velocity
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Tensiomyography (TMG) of left and right rectus femoris (RF) and biceps femoris (BF) heads. Muscle contraction displacement (Dm), delay time (Td) and contraction time (Tc) will be combined to calculate contraction velocity (Vc) of left/right RF and BF. Vc = [Dm/(Td +Tc)] (in millimeter/second).
Changes in level of fatigue
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Participants will complete the Multidimensional Fatigue Inventory (MFI-20) [range 4-20] with higher scores indicate a higher level of fatigue.
Changes in level of frailty
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Subjects will undergo the Edmonton Frail Scale survey [range 0 -17] with higher scores indicate a higher level of frailty.
Changes in health status
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Participants will complete the 36-Items Form Health survey (SF-36), [range 0-100] with higher score indicate better physical and mental health.
Changes in nutritional status
Time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Participants will complete the Mini Nutritional Assessment (MNA) survey [range 0-14] with higher score indicate better nutritional condition.
4 secondary outcomes
Changes in blood count
Time frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in lipid profiles
Time frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Changes in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Post-intervention time (24 weeks); Optional follow-up at 72 weeks (2nd follow-up) for participants who would be willing to continue their training.
Self-report measure of habitual physical activity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 36356628Bautmans I, Knoop V, Amuthavalli Thiyagarajan J, Maier AB, Beard JR, Freiberger E, Belsky D, Aubertin-Leheudre M, Mikton C, Cesari M, Sumi Y, Diaz T, Banerjee A; WHO Working Group on Vitality Capacity. WHO working definition of vitality capacity for healthy longevity monitoring. Lancet Healthy Longev. 2022 Nov;3(11):e789-e796. doi: 10.1016/S2666-7568(22)00200-8.
- Background: PubMed 34343305Beard JR, Si Y, Liu Z, Chenoweth L, Hanewald K. Intrinsic Capacity: Validation of a New WHO Concept for Healthy Aging in a Longitudinal Chinese Study. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):94-100. doi: 10.1093/gerona/glab226.
- Background: PubMed 31275941Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.
- Background: PubMed 29408961Cesari M, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Cooper C, Martin FC, Reginster JY, Vellas B, Beard JR. Evidence for the Domains Supporting the Construct of Intrinsic Capacity. J Gerontol A Biol Sci Med Sci. 2018 Nov 10;73(12):1653-1660. doi: 10.1093/gerona/gly011.
- Background: PubMed 35015816Cesari M, Sadana R, Sumi Y, Amuthavalli Thiyagarajan J, Banerjee A. What Is Intrinsic Capacity and Why Should Nutrition Be Included in the Vitality Domain? J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):91-93. doi: 10.1093/gerona/glab318. No abstract available.
- Background: PubMed 35994115De Luca A, Kuijf H, Exalto L, Thiebaut de Schotten M, Biessels GJ; Utrecht VCI Study Group. Multimodal tract-based MRI metrics outperform whole brain markers in determining cognitive impact of small vessel disease-related brain injury. Brain Struct Funct. 2022 Sep;227(7):2553-2567. doi: 10.1007/s00429-022-02546-2. Epub 2022 Aug 22.
- Background: PubMed 35182742Gallardo-Gomez D, Del Pozo-Cruz J, Noetel M, Alvarez-Barbosa F, Alfonso-Rosa RM, Del Pozo Cruz B. Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022 Apr;76:101591. doi: 10.1016/j.arr.2022.101591. Epub 2022 Feb 17.
- Background: PubMed 35395736Leung AYM, Su JJ, Lee ESH, Fung JTS, Molassiotis A. Intrinsic capacity of older people in the community using WHO Integrated Care for Older People (ICOPE) framework: a cross-sectional study. BMC Geriatr. 2022 Apr 8;22(1):304. doi: 10.1186/s12877-022-02980-1.
- Background: PubMed 29276545Levin O, Netz Y, Ziv G. The beneficial effects of different types of exercise interventions on motor and cognitive functions in older age: a systematic review. Eur Rev Aging Phys Act. 2017 Dec 21;14:20. doi: 10.1186/s11556-017-0189-z. eCollection 2017.
- Background: PubMed 36580713Levin O, Vints WAJ, Ziv G, Katkute G, Kusleikiene S, Valatkeviciene K, Sheoran S, Drozdova-Statkeviciene M, Gleizniene R, Paasuke M, Dudoniene V, Himmelreich U, Cesnaitiene VJ, Masiulis N. Neurometabolic correlates of posturography in normal aging and older adults with mild cognitive impairment: Evidence from a 1H-MRS study. Neuroimage Clin. 2023;37:103304. doi: 10.1016/j.nicl.2022.103304. Epub 2022 Dec 24.
- Background: PubMed 30984760Netz Y. Is There a Preferred Mode of Exercise for Cognition Enhancement in Older Age?-A Narrative Review. Front Med (Lausanne). 2019 Mar 29;6:57. doi: 10.3389/fmed.2019.00057. eCollection 2019.
- Background: PubMed 24605806Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Guidance on person-centred assessment and pathways in primary careLink provided by the sponsor.
- Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 1. The data collected in this study will be available to all collaborators in an interactive closed data repository. 2. Analyzed data will be available in an open-source data repository for all researchers upon request after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oron Levin, PhD principal investigator
Lithuanian Sports University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training in people with Mild Cognitive Impairment and Older Adults at High Risk for MCI, run by Lithuanian Sports University at 2 sites in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vida J Česnaitienė, PhD (+370 698 33646, vida.cesnaitiene@lsu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intrinsic capacity (time frame: Baseline, Mid-intervention time (12 weeks) and Post-intervention time (24 weeks); Optional: follow-up at 48 weeks (1st follow-up) and 72 weeks (2nd follow-up) for participants who would be willing to continue their training.). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06252844, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.