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

NCT ID: NCT06470568

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2027-03-31

Brief 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. 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, 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.

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Participants 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.

Group Type: EXPERIMENTAL

Progressive Resistance exercise training

Intervention Type: BEHAVIORAL

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).

Control Group

Participants 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Progressive Resistance exercise training

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role: collaborator

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Paulina Belen Sepulveda Figueroa

Academic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de La Frontera

Temuco, , Chile

Countries

Chile

Other Identifiers

11240905

Identifier Type: -

Identifier Source: org_study_id