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

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ClinicalTrials.gov Identifier: NCT03167840
Recruitment Status : Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
University of Santo Tomas Hospital, Philippines
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Physical and Cognitive Training Behavioral: Physical Training Behavioral: Cognitive training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : January 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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.



Primary Outcome Measures :
  1. Falls Rate [ Time Frame: 9 months ]
    Number of Falls over a period of time


Secondary Outcome Measures :
  1. Change in Physiologic Profile Assessment (PPA) score [ Time Frame: Baseline, 3 months, 9 months ]
    Physiologic risk for falls

  2. Change in Falls Risks for Older People in the Community (FROP-Com) Screen score [ Time Frame: Baseline, 3 months, 9 months ]
    Overall fall risk

  3. Change in Global Cognitive Function [ Time Frame: Baseline, 3 months, 9 months ]
    Montreal Cognitive Assessment (MoCA)

  4. Change in Memory Function [ Time Frame: Baseline, 3 months, 9 months ]
    Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS)

  5. Change in Executive Function [ Time Frame: Baseline, 3 months, 9 months ]
    Executive Function Performance Test (EFPT)

  6. Change in Balance [ Time Frame: Baseline, 3 months, 9 months ]
    Time Up and Go Test (TUGT)

  7. Change in Gait Speed [ Time Frame: Baseline, 3 months, 9 months ]
    10-Meter Walk Test (10MWT)

  8. Change in Muscle Strength [ Time Frame: Baseline, 3 months, 9 months ]
    30s-Chair-Stand Test (CST)


Other Outcome Measures:
  1. Change in Fear of Falling [ Time Frame: Baseline, 3 months, 9 months ]
    Falls Efficacy Scale - International

  2. Change in Quality of Life [ Time Frame: Baseline, 3 months, 9 months ]
    European Quality of life - five dimensions - five levels (EQ-5D-5L) questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167840


Locations
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Philippines
University of Santo Tomas
Manila, Metro Manila, Philippines, 1015
Sponsors and Collaborators
The Hong Kong Polytechnic University
University of Santo Tomas Hospital, Philippines
Investigators
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Principal Investigator: William Tsang, PhD The Hong Kong Polytechnic University - Department of Rehabilitation Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03167840     History of Changes
Other Study ID Numbers: HSEARS20170402001
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Hong Kong Polytechnic University:
falls prevention, older adults, mild cognitive impairment

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders