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Trial record 3 of 128 for:    Recruiting, Not yet recruiting, Available Studies | falls

Effect of Home Exercise on Reducing Falls

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ClinicalTrials.gov Identifier: NCT03599934
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Kwok, Chinese University of Hong Kong

Brief Summary:
This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.

Condition or disease Intervention/treatment Phase
Fall Other: Lifestyle integrated functional exercise program Other: Home safety assessment Not Applicable

Detailed Description:
This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial
Estimated Study Start Date : July 18, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LiFE training and home safety assessment
The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment
Other: Lifestyle integrated functional exercise program
Lifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months.

Other: Home safety assessment
Home safety assessment and modification that targets to reduce environmental risk factors of falls.

No Intervention: Control group
The control group will continue their usual daily routine.



Primary Outcome Measures :
  1. Fall [ Time Frame: 1.5 years ]
    Prospective fall data will be collected through telephone follow-up for 1.5 year


Secondary Outcome Measures :
  1. Handgrip strength [ Time Frame: Baseline and follow-up assessment at 6-month ]
    Hand grip strength will be assessed by handheld dynamometer

  2. Functional lower body strength [ Time Frame: Baseline and follow-up assessment at 6-month ]
    Five-time sit-to-stand test will be used to assess lower body strength

  3. Single leg standing balance [ Time Frame: Baseline and follow-up assessment at 6-month ]
    Single leg standing balance of both legs will be assessed

  4. 10-meter walk test [ Time Frame: Baseline and follow-up assessment at 6-month ]
    The usual walking speed on a 10-meter walkway

  5. Timed-up and Go test [ Time Frame: Baseline and follow-up assessment at 6-month ]
    The time required to stand up from a chair, walk 3-m, return, and sit down, in comfortable speed

  6. Timed-up and Go test with dual-task [ Time Frame: Baseline and follow-up assessment at 6-month ]
    The timed-up and Go test would be tested while asking the participants to do serial-3-subtraction

  7. Montreal Cognitive Assessment 5-minute protocol [ Time Frame: Baseline and follow-up assessment at 6-month ]
    A standardized cognitive test

  8. Activity level [ Time Frame: Baseline and follow-up assessment at 6-month ]
    Selected participants will be asked to wear an activity tracker for 7 days to examine their activity level

  9. Fall risk [ Time Frame: Baseline and follow-up assessment at 6-month ]
    Physiological Profile Assessment (PPA) will be used to assess fall risk



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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:

  • aged 60 or older
  • able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
  • able to walk for ≥ 10 meters
  • history of falls in the past 12 months
  • living in the community
  • without MCI or dementia according to the 5-minute Montreal Cognitive assessment
  • have a moderate fall risk or above as assessed by the Physiological Profile Assessment
  • able to understand Chinese.

Exclusion Criteria:

  • blindness
  • diagnosis of mental disorders (e.g., severe depression, schizophrenia)
  • any contraindications to exercise (e.g. unstable angina).

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): NCT03599934


Contacts
Contact: Freddy Man Hin Lam, PhD 23473811 freddylam@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control Not yet recruiting
Hong Kong, Hong Kong
Contact: Man Hin Lam, PhD    23473811    freddylam@cuhk.edu.hk   
Principal Investigator: Timothy Kwok, MD         
Sub-Investigator: Freddy Man Hin Lam, PhD         
Sub-Investigator: Tak Kee Dicky Choy, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Timothy Kwok, MD The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control

Responsible Party: Timothy Kwok, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03599934     History of Changes
Other Study ID Numbers: 2017.400
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Timothy Kwok, Chinese University of Hong Kong:
Elderly
Exercise
Fall
Home safety