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Completed

NCT Number: NCT03599934

Effect of Home Exercise on Reducing Falls

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.

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Key information

Conditions

Fall Behavior Motor Activity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lifestyle integrated functional exercise program

Other

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.

Home safety assessment

Other

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

Primary outcomes

  1. Fall

    Time frame: 1.5 years

    Prospective fall data will be collected through telephone follow-up for 1.5 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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