Effect of Home Exercise on Reducing Falls

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

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.

Study Overview

• Status: Completed
• Conditions: Fall
• Intervention / Treatment: Other: Lifestyle integrated functional exercise program; Other: Home safety assessment

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
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall	Prospective fall data will be collected through telephone follow-up for 1.5 year	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Hand grip strength will be assessed by handheld dynamometer	Baseline and follow-up assessment at 6-month
Functional lower body strength	Five-time sit-to-stand test will be used to assess lower body strength	Baseline and follow-up assessment at 6-month
Single leg standing balance	Single leg standing balance of both legs will be assessed	Baseline and follow-up assessment at 6-month
10-meter walk test	The usual walking speed on a 10-meter walkway	Baseline and follow-up assessment at 6-month
Timed-up and Go test	The time required to stand up from a chair, walk 3-m, return, and sit down, in comfortable speed	Baseline and follow-up assessment at 6-month
Timed-up and Go test with dual-task	The timed-up and Go test would be tested while asking the participants to do serial-3-subtraction	Baseline and follow-up assessment at 6-month
Montreal Cognitive Assessment 5-minute protocol	A standardized cognitive test	Baseline and follow-up assessment at 6-month
Activity level	Selected participants will be asked to wear an activity tracker for 7 days to examine their activity level	Baseline and follow-up assessment at 6-month
Fall risk	Physiological Profile Assessment (PPA) will be used to assess fall risk	Baseline and follow-up assessment at 6-month

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Exercise; Fall; Home safety
• Other Study ID Numbers: 2017.400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No