Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Physical and Cognitive Training; Behavioral: Physical Training; Behavioral: Cognitive training

• Registration Number: NCT03167840
• Lead Sponsor: The Hong Kong Polytechnic University

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 Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Study Start: 2017-09-06
• Primary Completion: 2018-01-31
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical and cognitive training (PACT)	Physical and Cognitive Training	Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.
Physical training alone (PT)	Physical Training	Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.
Cognitive training alone (CT)	Cognitive training	Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Falls Rate	9 months	Number of Falls over a period of time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Santo Tomas; 🇵🇭 Manila, Metro Manila, Philippines