Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— FallsPACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03167840
• Other study ID #: HSEARS20170402001
• Status: Active, not recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: April 26, 2018
• Start date: September 6, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: May 2017
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: August 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Physical and Cognitive Training
Physical Exercise and Cognitive Training
• Physical Training
Physical training alone
• Cognitive training
Cognitive training alone

Locations

Country	Name	City	State
Philippines	University of Santo Tomas	Manila	Metro Manila

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	University of Santo Tomas

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fear of Falling	Falls Efficacy Scale - International	Baseline, 3 months, 9 months
Other	Change in Quality of Life	European Quality of life - five dimensions - five levels (EQ-5D-5L) questionnaire	Baseline, 3 months, 9 months
Primary	Falls Rate	Number of Falls over a period of time	9 months
Secondary	Change in Physiologic Profile Assessment (PPA) score	Physiologic risk for falls	Baseline, 3 months, 9 months
Secondary	Change in Falls Risks for Older People in the Community (FROP-Com) Screen score	Overall fall risk	Baseline, 3 months, 9 months
Secondary	Change in Global Cognitive Function	Montreal Cognitive Assessment (MoCA)	Baseline, 3 months, 9 months
Secondary	Change in Memory Function	Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS)	Baseline, 3 months, 9 months
Secondary	Change in Executive Function	Executive Function Performance Test (EFPT)	Baseline, 3 months, 9 months
Secondary	Change in Balance	Time Up and Go Test (TUGT)	Baseline, 3 months, 9 months
Secondary	Change in Gait Speed	10-Meter Walk Test (10MWT)	Baseline, 3 months, 9 months
Secondary	Change in Muscle Strength	30s-Chair-Stand Test (CST)	Baseline, 3 months, 9 months