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

NCT06470568 | Active Not Recruiting DMC

• 1 other identifier: 11240905
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment; Resistance exercise training; Cognition; Dementia

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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).

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

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

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

Secondary Outcomes (5)

• Change in functional capacity measured via Short Physical Performance Battery (SPPB) after resistance exercise training.

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

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

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

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

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

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

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

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

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Progressive Resistance exercise training

Control Group

NO INTERVENTION

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.

Interventions

Progressive Resistance exercise training 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).

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: In the sample selection, demographic data from the city of Temuco from 2017 (INE, 2017) will be considered. This data indicates a population distribution of 69% women and 31% men among older adults
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \< body mass index \<30 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad de La Frontera: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Universidad de La Frontera

Temuco, 4811230, Chile

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The kinesiologists performing the assessments will be blind to the intervention. The blinding will extend to the data analysis team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CL (1)