AgingNCT06621368
Effect of Two Years of Resistance Training on Health Status in Postmenopausal Women: Longitudinal Study Active Aging.
A study testing Exercise in people with Aging, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Nov 2023to 23 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or older;
- physically independent;
- not have cardiovascular, musculoskeletal or metabolic limitations that prevent the practice of physical exercises or the execution of motor tests;
- not being on hormone replacement therapy;
- not being involved in physical exercise more than once a week, over the six months prior to the start of the study.
Who cannot join
- not participating in at least 85% of the training and not attending the assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
State University of Londrina
Londrina, Paraná, 86057-970
Edílson S Cyrino, PhD, 55 43 9139-4509, edilsoncyrino@gmail.com
About this study
Official title: Effect of Two Years of Resistance Training on Muscular Strength, Body Composition, Functional Fitness, Metabolic Biomarkers, Cognition, and Cardiac Parameters in Postmenopausal Women: Longitudinal Study Active Aging
Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed.
- Conditions
- Aging
- Being tested
- Exercise, Control-no treatment
- Keywords
- bone mineral density, health´s women, skeletal muscle mass, motor performance, strength training, metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Resistance traning
the RT program will consist of eight exercises for different body segments, namely: vertical bench press, horizontal leg press, low row, leg extension, scott curl, leg curl, triceps pulley and seated calf raise. Every 12 weeks of training, the program will be restructured with changes in the order in which the exercises are performed, the number of sets, the number of repetitions or the training system in an attempt to avoid a supposed adaptive plateau. The protocols in each stage will follow the recommendations for prescribing RT for the elderly, aiming at improving strength and hypertrophy, namely: a combination of single-joint and multi-joint exercises (free weights and machines), slow or moderate execution speed (ratio 1:2 for concentric and eccentric muscle actions, respectively), one to three sets of multiple repetitions, 8-12 RM or 10-15 RM, with recovery intervals between sets of one to two minutes, and a training frequency of two to three weekly sessions, on alternate days.
Control-no treatmentOther
Participants will maintain their daily activities.
| Study group | Role | What they receive |
|---|---|---|
| control group = participants maintained their usual activities normally | No intervention | Participants maintained their ususal activities normally |
| exercise group = participants performed two years of strength training | Experimental | Participants will performed two years of strength training Receives: Other: Exercise; Other: Control-no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Muscle mass
Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Secondary outcomes (9)
Cardiovascular risk factors
HDL-c (mg/dL), LDL-c (mg/dL), Total cholesterol (mg/dL), Glucose (mg/dL), triglycerides(mg/dL), C-reactive protein (mg/dL)
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Cardiac function
Echocardiography exams were performed accord- ing to current guidelines [18], at baseline and the end of the investigation, by an experienced echocardi- ographer blinded to patient status and group assign- ment, using a Philips ultrasound machine, model iE33 (Philips Medical Solutions, Noord Brabant, The Netherlands), equipped with an S5-1 and X5-1 transducer. According to current recommendations, cardiac chamber dimensions, volumes, and left ven- tricular mass were measured. Mitral inflow velocities were assessed using a pulsed-wave Doppler in the apical four-chamber view, with the sample volume placed between the tips of the mitral leaflets; veloci- ties were recorded at end-expiration. Tissue Doppler velocities were acquired at end-expiration, in the api- cal four-chamber view, with the sample positioned at the septal and lateral mitral annulus for determination of systolic (S'), early diastolic (E'), and late diastolic (A') velocities.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
MoCA
The Brazilian version ofthe Montreal Cognitive Assessment (MoCA) was used to analyze the global cognitive function. The MoCA is a screening tool composed of 12 individually punctuated tasks grouped into eight cognitive domains. The total score ranges from 0 to 30 (higher values reflect better cognition). Cognitive domains and their respective punctuations are as follows: short-term memory (delayed recall, 5 points); visuospatial abilities (cube drawing, 1 point, clock drawing, 3 points); executive function (trail making test, 1 point; phonemic verbal fluency, 1 point; verbal abstraction, 2 points); attention, concentration, andwork- ing memory (cancelation, 1 point; subtraction, 3 points; digit span, 2 points); language (naming, 3 points; sentence repetition, 2 points); and orientation to time (3 points) and space (3 points).
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Stroop test
The Stroop test version used in the present study consisted of 36 tasks. In every trial, one cue appeared at the top part of the screen and the bottom two response options, one matched and one mismatched. Participants had to press the directional button (\< or \>) corresponding to the position ofthe correct response as quickly and accurately as possible. The test consisted of three stages with 12 trials each: (I-congruent) an inked rect- angle (green, black, red, or blue) appeared, and participants had to choose the response corresponding to the ink name; (II- neutral) a color name (green, black, red, or blue) appeared in white ink, and participants had to choose the option corresponding to the color name; (III-incongruent) a color name appeared at the top of the screen in a different ink color (e.g., the word black in green ink). The participants had to respond to the ink color, not the color name (e.g., green in this example).
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Set shifting
The Trail Making Tests parts A and B were used to assess set shifting. Part A assesses the psychomotor speed and requires the participant to draw lines that connect encircled numbers sequentially, such as drawing a line from 1 to 2, 2 to 3, 3 to 4, and so on. Part B consists ofencircled numbers and letters. Participants were instructed to draw a line as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they completed the task. We recorded the time (in seconds) they took to complete each task. We calculated the difference between part B and part A completion times to index set shifting. Smaller difference scores indicate better set shifting.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Verbal fluency tasks
Participants were asked to say asmany words as possible within 60 s (31). In the first trial, par- ticipants had to produce words starting with the letter "F" (letter fluency) and produce the name of animals (category fluency). The final score refers to the number ofwords correctly spoken in 60 s.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Depressive symptoms
The 15-item Geriatric Depres- sion Scale (GDS-15): The GDS-15 comprises 15 dichotomic items (yes or not) concerning different characteristics of geriatric depression as cognitive decline and somatic symptoms, with the final score ranging from 0 to 15, where the higher scores are worse.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Anxiety symptoms
Beck Anxiety Inventory (BAI): The BAI comprises 21 items (statements) about different anxiety symptoms with a 4-point Likert scale, with the final score ranging from 0 to 63, where the higher scores are worse.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Bone
Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total and regional bone mineral density (cm/m²). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.
Measured: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start23 Nov 2023
- Primary completion20 Dec 2025 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edilson Serpeloni Cyrino, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621368
- Sponsor's protocol ID
- GEPEMENE 2024b
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nabuco HCG, Tomeleri CM, Sugihara Junior P, Fernandes RR, Cavalcante EF, Antunes M, Ribeiro AS, Teixeira DC, Silva AM, Sardinha LB, Cyrino ES. Effects of Whey Protein Supplementation Pre- or Post-Resistance Training on Muscle Mass, Muscular Strength, and Functional Capacity in Pre-Conditioned Older Women: A Randomized Clinical Trial. Nutrients. 2018 May 3;10(5):563. doi: 10.3390/nu10050563.
PubMed 29751507Dos Santos L, Cyrino ES, Antunes M, Santos DA, Sardinha LB. Sarcopenia and physical independence in older adults: the independent and synergic role of muscle mass and muscle function. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):245-250. doi: 10.1002/jcsm.12160. Epub 2016 Nov 8.
PubMed 27897417
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Years of Resistance Training on Muscular Strength, Body Composition, Functional Fitness, Metabolic Biomarkers, Cognition, and Cardiac Parameters in Postmenopausal Women: Longitudinal Study Active Aging
- ClinicalTrials.gov ID
- NCT06621368
- Acronym / sponsor ID
- GEPEMENE 2024b
- Conditions
- Aging
- Keywords
- bone mineral density, health´s women, skeletal muscle mass, motor performance, strength training, metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 1 Oct 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.
Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group = participants maintained their usual activities normally | No intervention | –Participants maintained their ususal activities normally |
| exercise group = participants performed two years of strength training | Experimental | Other: Exercise, Other: Control-no treatmentParticipants will performed two years of strength training |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years of age or older;
- physically independent;
- not have cardiovascular, musculoskeletal or metabolic limitations that prevent the practice of physical exercises or the execution of motor tests;
- not being on hormone replacement therapy;
- not being involved in physical exercise more than once a week, over the six months prior to the start of the study.
Key exclusion criteria (1 listed)
- not participating in at least 85% of the training and not attending the assessments.
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 |
|---|---|---|
| ExerciseAlso: Resistance traningthe RT program will consist of eight exercises for different body segments, namely: vertical bench press, horizontal leg press, low row, leg extension, scott curl, leg curl, triceps pulley and seated calf raise. Every 12 weeks of training, the program will be restructured with changes in the order in which the exercises are performed, the number of sets, the number of repetitions or the training system in an attempt to avoid a supposed adaptive plateau. The protocols in each stage will follow the recommendations for prescribing RT for the elderly, aiming at improving strength and hypertrophy, namely: a combination of single-joint and multi-joint exercises (free weights and machines), slow or moderate execution speed (ratio 1:2 for concentric and eccentric muscle actions, respectively), one to three sets of multiple repetitions, 8-12 RM or 10-15 RM, with recovery intervals between sets of one to two minutes, and a training frequency of two to three weekly sessions, on alternate days. | Other | exercise group = participants performed two years of strength training |
| Control-no treatmentParticipants will maintain their daily activities. | Other | exercise group = participants performed two years of strength training |
Primary outcome
Body Fat
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.
Muscle mass
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.
9 secondary outcomes
Cardiovascular risk factors
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Cardiac function
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
MoCA
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Stroop test
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Set shifting
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Verbal fluency tasks
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Depressive symptoms
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Anxiety symptoms
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Bone
Time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 29751507Nabuco HCG, Tomeleri CM, Sugihara Junior P, Fernandes RR, Cavalcante EF, Antunes M, Ribeiro AS, Teixeira DC, Silva AM, Sardinha LB, Cyrino ES. Effects of Whey Protein Supplementation Pre- or Post-Resistance Training on Muscle Mass, Muscular Strength, and Functional Capacity in Pre-Conditioned Older Women: A Randomized Clinical Trial. Nutrients. 2018 May 3;10(5):563. doi: 10.3390/nu10050563.
- Background: PubMed 27897417Dos Santos L, Cyrino ES, Antunes M, Santos DA, Sardinha LB. Sarcopenia and physical independence in older adults: the independent and synergic role of muscle mass and muscle function. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):245-250. doi: 10.1002/jcsm.12160. Epub 2016 Nov 8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging, run by Universidade Estadual de Londrina at 1 site in Brazil.
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 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat (time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)). The study lists 2 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 NCT06621368, which also lists 2 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 1 Oct 2024.