Resistance Exercise Training in Individuals Aged 60 and Older With Mild Cognitive Impairment
NCT Number: NCT06470568
Acronym: RET-MCI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mild Cognitive Impairment
Interventions: BEHAVIORAL: Progressive Resistance exercise training
Sponsor: Universidad de La Frontera
Collaborators: Agencia Nacional de Investigación y Desarrollo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-03

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.

Primary Outcome Measures: 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 Outcome Measures: 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)., 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 functional capacity is assessed through the adapted Timed Up and Go test (TUG)., 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 functional capacity is assessed through the T-ADLQ questionnaire., The assessment will be conducted before and after the 12-week intervention|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., 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., 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, he assessment will be conducted before and after the 12-week intervention