Home Balance Pilot for Fall Reduction in COPD

Study Overview
=================
Brief Summary
-----------------
There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD. The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability. Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.

Official Title
-----------------
Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Behavioral: Home balance exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a clinical diagnosis of COPD; age ≥ 60 yrs; a history of 1 or more falls in the previous year; ability to provide written informed consent. Exclusion Criteria: inability to communicate in English; history of significant cardiovascular disease; marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity; severe cognitive impairment; evidence of a condition that severely limits mobility and may jeopardize safety; completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home balance exercise program<br>The home-based exercise program will be tailored to address the underlying balance deficits in COPD and individualized according to each participant's ability. Physiotherapists will teach the program in four home visits over the first 6 weeks of the study; in the event of an exacerbation, a fifth visit will be provided to modify the program. Participants will be given an exercise DVD (with portable player), and will be instructed to perform the program 3 times/week for 6 months. Therapists will provide bi-monthly telephone support. | Behavioral: Home balance exercise program<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Percentage of eligible patients that consent to enroll in the study | Baseline | 
| Retention rate | Percentage of the sample that complete all 3 outcome assessments | 6 months | 
| Compliance | Mean number of prescribed exercise sessions completed | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Measure of balance | baseline, 3 months, 6 months | 
| Balance Evaluation Systems Test (BESTest) | Measure of balance | baseline, 3 months, 6 months | 
| Activity-Specific Balance Confidence questionnaire | Measure of balance confidence | baseline, 3 months, 6 months | 
| 30-second Sit-to-Stand Test | Measure of functional lower body strength | baseline 3 months, 6 months | 
| Self-reported function (PF-10) | Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey | baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Falls, Balance, Exercise, COPD