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Mild Cognitive ImpairmentRET-MCINCT06470568

Resistance Exercise Training in Individuals Aged 60 and Older With Mild Cognitive Impairment

A study testing Progressive Resistance exercise training in people with Mild Cognitive Impairment, run by Universidad de La Frontera at 1 site in Chile.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aging population in Chile and worldwide is increasing, with older people expected to represent 32.1% of the population by 2050. This demographic shift brings age-related pathologies such as dementia, a leading cause of disability and dependence among older individuals globally. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Progressive Resistance exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChile
Study dates
15 Aug 2024to Mar 2027
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with Mild Cognitive Impairment will be identified through the administration of the standard MoCA test and the Pfeffer Functional Activities Questionnaire (PFAQ). Both assessments will be conducted in a single evaluation session by an expert neurologist.
  • 18.5 < body mass index <30 kg/m2

Who cannot join

  • Performing regular resistance exercise training in the previous 6 months
  • Unstable cardiac diseases, or individuals who have had a stroke in the last 6 months
  • Significant psychiatric or neurological disorders, with the use of acetylcholinesterase inhibitors, and untreated mood disorders or depressive pathology
  • Neuromuscular or mobility disorders that prevent safe resistance training (debilitating arthritis, spasticity/rigidity, and paralysis), along with untreated metabolic disorders (such as uncontrolled systemic hypertension)

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Universidad de La Frontera

    Temuco, 4811230

Other trials in Chile

About this study

Official title: Comparison of Progressive Resistance Exercise Training and Usual Therapy in People Over 60 Years of Age With Mild Cognitive Impairment: Effects on Cognitive Function, Skeletal Muscle Mass, and Strength

The aging population in Chile and worldwide is increasing, with older people expected to represent 32.1% of the population by 2050. This demographic shift brings age-related pathologies such as dementia, a leading cause of disability and dependence among older individuals globally. Mild cognitive impairment (MCI) precedes dementia and presents a critical therapeutic window for halting or slowing its progression. While resistance exercise training appears promising for this at-risk population, few studies have evaluated its effects on cognitive function and muscle strength in individuals with MCI.

Hypothesis: Twelve weeks of progressive resistance exercise training will significantly improve cognitive function, skeletal muscle mass, and strength in people over 60 years of age with MCI compared to the usual therapy in the control group.

Read more

Goal: The main objective of this study is to compare the effect of progressive resistance exercise training with usual therapy (control group) on cognitive function, skeletal muscle mass, and strength in individuals over 60 years of age with mild cognitive impairment.

Methodology: In this randomized controlled trial, we will recruit 60 participants (both men and women) aged 60 years or older. Participants will be identified with MCI using the MoCA and Pfeffer Functional Activities Questionnaire (PFAQ). They will be randomly assigned to two equal groups: a control group (receiving usual therapy) and an intervention group (receiving usual therapy plus resistance training). All participants in both groups will be evaluated before (Pre-time 0) and after (Post-time 1) the intervention. During the evaluations, samples and measurements will be taken, including fasting blood samples for BDNF and CTSB measurement, whole-body dual-energy X-ray absorptiometry (DEXA) to assess global muscle mass, and magnetic resonance imaging of the quadriceps and brain. Global cognitive function will be evaluated using the ACEIII test, maximum strength with 1 repetition maximum (1RM), functional capacity with the Short Physical Performance Battery (SPPB), adapted Timed Up and Go (TUG) test, Activities of Daily Living Questionnaire (T-ADLQ). Finally, quality of life will be assessed using the WHOQOL-BREF scale.

Read the detailed description

The aging population in Chile and worldwide is increasing, with older people expected to represent 32.1% of the population by 2050. This demographic shift brings age-related pathologies such as dementia, a leading cause of disability and dependence among older individuals globally. Mild cognitive impairment (MCI) precedes dementia and presents a critical therapeutic window for halting or slowing its progression. While resistance exercise training appears promising for this at-risk population, few studies have evaluated its effects on cognitive function and muscle strength in individuals with MCI.

Hypothesis: Twelve weeks of progressive resistance exercise training will significantly improve cognitive function, skeletal muscle mass, and strength in people over 60 years of age with MCI compared to the usual therapy in the control group.

Goal: The main objective of this study is to compare the effect of progressive resistance exercise training with usual therapy (control group) on cognitive function, skeletal muscle mass, and strength in individuals over 60 years of age with mild cognitive impairment.

Methodology: In this randomized controlled trial, 60 participants (both men and women) aged 60 years or older will be recruited. Participants will be identified with MCI using the Montreal Cognitive Assessment (MoCA) and the Pfeffer Functional Activities Questionnaire (PFAQ). They will be randomly assigned to two equal groups: a control group (receiving usual therapy) and an intervention group (receiving usual therapy plus resistance training). Participants in the control group will receive usual care for 12 weeks, including one medical review and one educational talk. Participants in the intervention group will maintain their usual therapy and will participate in supervised full-body resistance training with a kinesiologist, performing exercises three times per week for 12 weeks. All participants in both groups will be evaluated before (Pre-time 0) and after (Post-time 1) the intervention. During the evaluations, samples and measurements will be taken, including fasting blood samples for BDNF and CTSB measurement, whole-body dual-energy X-ray absorptiometry (DEXA) to assess global muscle mass, and magnetic resonance imaging of the quadriceps and brain. Global cognitive function will be evaluated using the ACEIII test, maximum strength with 1 repetition maximum (1RM), functional capacity with the Short Physical Performance Battery (SPPB), adapted Timed Up and Go (TUG) test, Activities of Daily Living Questionnaire (T-ADLQ). Finally, quality of life will be assessed using the WHOQOL-BREF scale. Expected Results: Few studies worldwide, and none in Chile, have evaluated the effects of resistance training on cognitive function, muscle mass, and strength gain in individuals with mild cognitive impairment, or the correlation between increased muscle strength and cognition. There are also no protocols or clinical guidelines for resistance training in this at-risk population. The impact of resistance exercise on cognitive function in individuals with MCI remains unclear. The proposed research will provide new insights into the effectiveness of resistance training on cognition in individuals with MCI over 60 years of age. We hope that our findings will be of significant value in the development of future interventions to prevent or postpone the progression of dementia.

Being tested
Progressive Resistance exercise training
Keywords
Mild cognitive impairment, Resistance exercise training, Cognition, Dementia
Medical subject headings
Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Resistance exercise trainingBehavioural

    The training sessions will begin with a 5-minute warm-up on a cycle ergometer and global movements involving the upper limbs. Following this, participants will perform one additional warm-up set, followed by four regular sets on both the leg press and leg extension machines. Upper body exercises will then be conducted on the chest press, pull-up, and horizontal rowing machines, with each exercise comprising 2 sets.

    To conclude each session, there will be a 5-minute cooldown period involving global muscle stretching exercises. During the initial 6-week period, the workload will progressively increase from 60% to 80% of 1RM (10 repetitions per set). Subsequently, the 1RM will be reassessed to adjust workloads (maintaining 60%-80%) for the subsequent 6-week period. Compliance for per-protocol analysis will require participants to complete at least 80% of the training sessions (i.e., a minimum of 29 out of 36 sessions).

Study groups in NCT06470568
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants assigned to the intervention group will perform a supervised Progressive Resistance Exercise Training program for the whole body three times per week for 12 weeks.
Receives: Behavioral: Progressive Resistance exercise training
Control GroupNo interventionParticipants assigned to the control group will receive the usual therapy, medical monitoring, and educational lectures. They will be instructed to maintain their current physical condition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cognitive Function measured via Addenbrooke's Cognitive Examination III (ACE III) after resistance exercise training

    It will be assessed with the Addenbrooke's Cognitive Examination III (ACE III) (Hsieh et al., 2013), which was developed to overcome the neuropsychological omissions present in the Mini-Mental State Examination (MMSE) (Carnero-Pardo, 2014). This examination is sensitive to cognitive changes in the early stages of cognitive impairment (Slachevsky et al., 2014; Matías-Guiu et al., 2018). The questionnaire, adapted and validated for the Chilean population (Bruno et al., 2020), showed a sensitivity of 98% and a specificity of 82%. It is composed of five domains: attention, memory, language, verbal fluency, and visuospatial skills, and takes no more than 20 minutes to complete. The result is based on a maximum score of 100 points, where higher scores indicate better memory and cognitive performance.

    Measured: The assessment will be conducted before and after the 12-week intervention

  2. Change in body composition measured via dual-energy X-ray absorptiometry scanning after resistance exercise training

    Whole-body and regional lean mass and whole-body fat mass were determined by dual-energy X-ray absorptiometry scanning (Lunar General Electric iDEXA, General Electric Medical Systems). In addition, weight, height, waist circumference, and leg volume were determined.

    Measured: The assessment will be conducted before and after the 12-week intervention

  3. Change in muscle strength measured via 1RM strength tests after resistance exercise training.

    Maximum strength was assessed using 1RM strength tests. Maximum strength was first estimated using the multiple-repetition procedure during the familiarization trial. In a separate session, 1RM strength was subsequently determined for all lower and upper body exercises on the same equipment as used for training. In addition, maximal handgrip strength was obtained using a Jamar electronic handheld dynamometer (model Plus+, Patterson Medical).

    Measured: The assessment will be conducted before and after the 12-week intervention

  4. Change in quadriceps muscle volume (QMV) measured via magnetic resonance imaging (MRI)

    Measured: The assessment will be conducted before and after the 12-week intervention

Secondary outcomes (5)
  1. Change in functional capacity measured via Short Physical Performance Battery (SPPB) after resistance exercise training.

    The functional capacity is assessed through the Short Physical Performance Battery (SPPB).

    Measured: The assessment will be conducted before and after the 12-week intervention

  2. Change in functional capacity measured via Timed Up and Go test (TUG) after resistance exercise training.

    The functional capacity is assessed through the adapted Timed Up and Go test (TUG).

    Measured: The assessment will be conducted before and after the 12-week intervention

  3. Change in functional capacity measured via T-ADLQ questionnaire after resistance exercise training.

    The functional capacity is assessed through the T-ADLQ questionnaire.

    Measured: The assessment will be conducted before and after the 12-week intervention

  4. Change in biomarkes measured via blood samples after resistance exercise training.

    Blood samples will be collected in EDTA-containing tubes and centrifuged at 3000 rpm for 15 minutes at room temperature. Subsequently, cell-free plasma will be aliquoted into cryovials and stored at -80°C until analysis for CTSB and BDNF. Quantification of CTSB and BDNF in plasma will be conducted using ELISA kits for total BDNF (R\&D Systems, Minneapolis, MN, USA) and CTSB (Abcam, Cambridge, MA, USA), following the manufacturers' specifications.

    Measured: The assessment will be conducted before and after the 12-week intervention

  5. Change in quality of life measured via WHOQOL-BREF scale after resistance exercise training.

    The WHOQOL-BREF scale assesses health-related quality of life. This scale consists of 26 items that evaluate four domains of quality of life: physical health, psychological health, social relationships, and environmen

    Measured: he assessment will be conducted before and after the 12-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start15 Aug 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06470568
Sponsor's protocol ID
11240905
Acronym
RET-MCI
Status last verified
Jan 2025
First submitted
17 Jun 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Resistance exercise training in people with Mild Cognitive Impairment, run by Universidad de La Frontera at 1 site in Chile.

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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. 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 Chile. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function measured via Addenbrooke's Cognitive Examination III (ACE III) after resistance exercise training (time frame: The assessment will be conducted before and after the 12-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jan 2025.

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