Clinical trial NCT06470568: Resistance Exercise Training in Individuals Aged 60 and Older With Mild Cognitive Impairment
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Resistance exercise training
Cognition
Dementia
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2024-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Cognitive Function measured via Addenbrooke's Cognitive Examination III (ACE III) after resistance exercise training
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in body composition measured via dual-energy X-ray absorptiometry scanning after resistance exercise training
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in muscle strength measured via 1RM strength tests after resistance exercise training.
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in quadriceps muscle volume (QMV) measured via magnetic resonance imaging (MRI)
timeFrame: The assessment will be conducted before and after the 12-week intervention
Secondary outcomes:
measure: Change in functional capacity measured via Short Physical Performance Battery (SPPB) after resistance exercise training.
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in functional capacity measured via Timed Up and Go test (TUG) after resistance exercise training.
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in functional capacity measured via T-ADLQ questionnaire after resistance exercise training.
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in biomarkes measured via blood samples after resistance exercise training.
timeFrame: The assessment will be conducted before and after the 12-week intervention
measure: Change in quality of life measured via WHOQOL-BREF scale after resistance exercise training.
timeFrame: he assessment will be conducted before and after the 12-week intervention
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
References: