Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Falls Rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Physical training alone (PT)
Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.
Intervention: Physical Training (Behavioral)
Cognitive training alone (CT)
Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks.
Intervention: Cognitive training (Behavioral)
Physical and cognitive training (PACT)
Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.
Intervention: Physical and Cognitive Training (Behavioral)
Wait-list group (WG)
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.
Outcomes
Primary Outcomes
Falls Rate
Time Frame: 9 months
Number of Falls over a period of time
Secondary Outcomes
- Change in Executive Function(Baseline, 3 months, 9 months)
- Change in Balance(Baseline, 3 months, 9 months)
- Change in Physiologic Profile Assessment (PPA) score(Baseline, 3 months, 9 months)
- Change in Gait Speed(Baseline, 3 months, 9 months)
- Change in Muscle Strength(Baseline, 3 months, 9 months)
- Change in Falls Risks for Older People in the Community (FROP-Com) Screen score(Baseline, 3 months, 9 months)
- Change in Global Cognitive Function(Baseline, 3 months, 9 months)
- Change in Memory Function(Baseline, 3 months, 9 months)