Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment (FallsPACT)

April 26, 2018 updated by: The Hong Kong Polytechnic University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1015
        • University of Santo Tomas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical training alone (PT)
Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.
Behavioral: Physical Training
Physical training alone
Other Names:
  • Physical exercise
Experimental: 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.
Behavioral: Cognitive training
Cognitive training alone
Other Names:
  • Mental exercise
Experimental: Physical and cognitive training (PACT)
Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.
Behavioral: Physical and Cognitive Training
Physical Exercise and Cognitive Training
Other Names:
  • Integrated cognitive training in physical exercise
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fear of Falling
Time Frame: Baseline, 3 months, 9 months
Falls Efficacy Scale - International
Baseline, 3 months, 9 months
Change in Quality of Life
Time Frame: Baseline, 3 months, 9 months
European Quality of life - five dimensions - five levels (EQ-5D-5L) questionnaire
Baseline, 3 months, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

University of Santo Tomas

Investigators

  • Principal Investigator: William Tsang, PhD, The Hong Kong Polytechnic University - Department of Rehabilitation Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2017

Primary Completion (Actual)

January 31, 2018

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20170402001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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