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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Physical and Cognitive Training
Physical Training
Cognitive training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring falls prevention, older adults, mild cognitive impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Santo Tomas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Physical training alone (PT)

Cognitive training alone (CT)

Physical and cognitive training (PACT)

Wait-list group (WG)

Arm Description

Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.

Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks.

Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.

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 Outcome Measures

Falls Rate
Number of Falls over a period of time

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2017
Last Updated
April 26, 2018
Sponsor
The Hong Kong Polytechnic University
Collaborators
University of Santo Tomas
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1. Study Identification

Unique Protocol Identification Number
NCT03167840
Brief Title
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
Acronym
FallsPACT
Official Title
Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
University of Santo Tomas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
falls prevention, older adults, mild cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical training alone (PT)
Arm Type
Experimental
Arm Description
Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.
Arm Title
Cognitive training alone (CT)
Arm Type
Experimental
Arm Description
Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks.
Arm Title
Physical and cognitive training (PACT)
Arm Type
Experimental
Arm Description
Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.
Arm Title
Wait-list group (WG)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical and Cognitive Training
Other Intervention Name(s)
Integrated cognitive training in physical exercise
Intervention Description
Physical Exercise and Cognitive Training
Intervention Type
Behavioral
Intervention Name(s)
Physical Training
Other Intervention Name(s)
Physical exercise
Intervention Description
Physical training alone
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
Mental exercise
Intervention Description
Cognitive training alone
Primary Outcome Measure Information:
Title
Falls Rate
Description
Number of Falls over a period of time
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change in Physiologic Profile Assessment (PPA) score
Description
Physiologic risk for falls
Time Frame
Baseline, 3 months, 9 months
Title
Change in Falls Risks for Older People in the Community (FROP-Com) Screen score
Description
Overall fall risk
Time Frame
Baseline, 3 months, 9 months
Title
Change in Global Cognitive Function
Description
Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline, 3 months, 9 months
Title
Change in Memory Function
Description
Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS)
Time Frame
Baseline, 3 months, 9 months
Title
Change in Executive Function
Description
Executive Function Performance Test (EFPT)
Time Frame
Baseline, 3 months, 9 months
Title
Change in Balance
Description
Time Up and Go Test (TUGT)
Time Frame
Baseline, 3 months, 9 months
Title
Change in Gait Speed
Description
10-Meter Walk Test (10MWT)
Time Frame
Baseline, 3 months, 9 months
Title
Change in Muscle Strength
Description
30s-Chair-Stand Test (CST)
Time Frame
Baseline, 3 months, 9 months
Other Pre-specified Outcome Measures:
Title
Change in Fear of Falling
Description
Falls Efficacy Scale - International
Time Frame
Baseline, 3 months, 9 months
Title
Change in Quality of Life
Description
European Quality of life - five dimensions - five levels (EQ-5D-5L) questionnaire
Time Frame
Baseline, 3 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Tsang, PhD
Organizational Affiliation
The Hong Kong Polytechnic University - Department of Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Santo Tomas
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1015
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30143002
Citation
Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
Results Reference
derived

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Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment

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