Effect of Home Exercise on Reducing Falls

Study Overview
=================
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.

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

Conditions
-----------------
Fall

Intervention / Treatment
-----------------
* Other: Lifestyle integrated functional exercise program
* Other: Home safety assessment


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiFE training and home safety assessment<br>The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment | Other: Lifestyle integrated functional exercise program<br>* 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.<br>Other: Home safety assessment<br>* Home safety assessment and modification that targets to reduce environmental risk factors of falls.<br>|
| No Intervention: Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Exercise, Fall, Home safety