Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment

Study Overview
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Brief Summary
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This randomised controlled trial aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with mild cognitive impairment (MCI).

Detailed Description
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This is a single-blind, multicentre, randomised controlled trial. Community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and wait-list group (WG). Assessors blinded to participant allocation will conduct pre-test, posttest, and 6-month follow-up assessments.

Official Title
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Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Physical and Cognitive Training
* Behavioral: Physical Training
* Behavioral: Cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years or above community-dwelling in Manila, Philippines diagnosed with MCI Exclusion Criteria: diagnosis of dementia or Alzheimer's disease history of major medical conditions such as cerebrovascular disease, cardiopulmonary condition, serious musculoskeletal disease, cancer, major psychiatric condition have severe visual and/or hearing impairment taking medications such sedatives, antidepressants, diuretics, anti-epilepsy.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical training alone (PT)<br>Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity. | Behavioral: Physical Training<br>* Physical training alone<br>* Other names: Physical exercise;|
| Experimental: Cognitive training alone (CT)<br>Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks. | Behavioral: Cognitive training<br>* Cognitive training alone<br>* Other names: Mental exercise;|
| Experimental: Physical and cognitive training (PACT)<br>Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks. | Behavioral: Physical and Cognitive Training<br>* Physical Exercise and Cognitive Training<br>* Other names: Integrated cognitive training in physical exercise;|
| No Intervention: Wait-list group (WG)<br>The control group on wait-list. They will be instructed to go on with their usual activities and will receive the intervention, combined physical and cognitive training, at a later date. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Rate | Number of Falls over a period of time | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physiologic Profile Assessment (PPA) score | Physiologic risk for falls | Baseline, 3 months, 9 months | 
| Change in Falls Risks for Older People in the Community (FROP-Com) Screen score | Overall fall risk | Baseline, 3 months, 9 months | 
| Change in Global Cognitive Function | Montreal Cognitive Assessment (MoCA) | Baseline, 3 months, 9 months | 
| Change in Memory Function | Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) | Baseline, 3 months, 9 months | 
| Change in Executive Function | Executive Function Performance Test (EFPT) | Baseline, 3 months, 9 months | 
| Change in Balance | Time Up and Go Test (TUGT) | Baseline, 3 months, 9 months | 
| Change in Gait Speed | 10-Meter Walk Test (10MWT) | Baseline, 3 months, 9 months | 
| Change in Muscle Strength | 30s-Chair-Stand Test (CST) | Baseline, 3 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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falls prevention, older adults, mild cognitive impairment