Effect of Home Exercise on Reducing Falls

Not Applicable

Completed

• Conditions: Fall
• Interventions: Other: Lifestyle integrated functional exercise program; Other: Home safety assessment

• Registration Number: NCT03599934
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study Start: 2018-07-18
• Study First Posted: 2018-07-26
• Primary Completion: 2020-11-10
• Study Completion: 2021-10-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LiFE training and home safety assessment	Home safety assessment	The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment
LiFE training and home safety assessment	Lifestyle integrated functional exercise program	The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment

Primary Outcome Measures

Name	Time	Method
Fall	1.5 years	Prospective fall data will be collected through telephone follow-up for 1.5 year

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment 5-minute protocol	Baseline and follow-up assessment at 6-month	A standardized cognitive test
Handgrip strength	Baseline and follow-up assessment at 6-month	Hand grip strength will be assessed by handheld dynamometer
Activity level	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
Fall risk	Baseline and follow-up assessment at 6-month	Physiological Profile Assessment (PPA) will be used to assess fall risk
Single leg standing balance	Baseline and follow-up assessment at 6-month	Single leg standing balance of both legs will be assessed
10-meter walk test	Baseline and follow-up assessment at 6-month	The usual walking speed on a 10-meter walkway
Timed-up and Go test	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
Timed-up and Go test with dual-task	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
Functional lower body strength	Baseline and follow-up assessment at 6-month	Five-time sit-to-stand test will be used to assess lower body strength

Trial Locations

Locations (2)

The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control; 🇭🇰 Hong Kong, Hong Kong

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong