Balance Training for Fall Reduction in COPD

Not Applicable

Terminated

• Conditions: Copd; Fall Patients

• Registration Number: NCT02995681
• Lead Sponsor: West Park Healthcare Centre

Brief Summary

People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their balance and a high incidence of falls compared to those of a similar age. Pulmonary rehabilitation is recommended for people with COPD, however, these training programs do not typically include balance training or fall prevention strategies. In this study, patients with COPD who report problems with their balance or have had a fall in the last two years will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or control group (standard pulmonary rehabilitation). We will record the number of falls using monthly diaries and evaluate patient's balance, strength, confidence and quality of life.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in Canada. In addition to lung impairment, secondary effects of the disease are well established including impairments in muscle function and exercise capacity. However, individuals with COPD also have marked deficits in balance and an increased risk of falls with a 3-5 times higher annual fall rate than those of similar age. The underlying mechanisms remain unclear, but several factors have been implicated including decreased physical activity, muscle weakness, altered trunk mechanics, comorbidities, hypoxemia and proprioceptive deficits. Given this unique impairment profile, tailored approaches to balance training and fall prevention are needed in COPD.

Pulmonary rehabilitation (PR) is an integral therapeutic intervention for individuals with COPD. The program typically consists of supervised exercise, disease-specific education, and psychological and social support. Balance training and fall prevention strategies are not currently included in international guidelines for PR and few programs include any balance assessment. We have previously shown that the exercise component of traditional PR has minimal effect on measures of balance and fall risk. We then conducted an RCT to examine the effects of balance training alongside PR, which specifically addressed the profile of balance deficits we had identified in COPD. Tailored balance training alongside PR results in clinically important improvements in balance performance compared to PR alone. Given these results, we now have the opportunity to build on our existing experience to test the effect of the intervention on falls.

The purpose of this study is to establish the efficacy of a tailored balance exercise program for reducing falls in individuals with COPD enrolled in PR. If participation in tailored balance training decreases falls compared to usual PR, this approach will represent an innovative and potential cost-saving strategy to prevent falls and reduce associated healthcare utilization in COPD. Our results will be relevant for guiding clinical and policy-based decision making, given the large population of individuals with COPD and the potential for severe consequences of falls in this population.

The primary objective of this study is to evaluate the long-term effects of tailored balance exercise on the rate of falls in individuals with COPD enrolled in PR. Secondary objectives are to determine 1) the long-term effects of the program on measures of balance, balance confidence and muscle strength; and 2) the cost-utility of the program.

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-16
• Study Start: 2017-01
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• a physician diagnosis of COPD based on GOLD criteria; a self-reported decline in balance, a fall within the last two years or a recent near fall; and an ability to provide written informed consent

Exclusion Criteria

• severe cognitive impairment (dementia, neurological condition) an inability to communicate because of language skills (aphasia, non-English speaking), or evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g. cerebrovascular accident, Parkinson's Disease, amputation) and may jeopardize their safety or influence their balance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of falls	12 months	Number of falls will be measured using monthly falls diaries

Secondary Outcome Measures

Name	Time	Method
Balance Evaluation Systems Test (BESTest)	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months	Clinical measure of balance
Activities Specific Balance Confidence Scale	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months	Balance confidence questionnaire
30 Second Repeated Chair Stand Test	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months	Functional lower body strength test
European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months	Health status questionnaire
Berg Balance Scale	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months	Clinical measure of balance

Trial Locations

Locations (10)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia

Western Health; 🇦🇺 Saint Albans, Victoria, Australia

G.F. Macdonald Centre for Lung Health; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Pulmonary Rehab Program; 🇨🇦 Vancouver, British Columbia, Canada

Colchester East Hants Health Authority; 🇨🇦 Truro, Nova Scotia, Canada

Ottawa Hospital Rehabilitation Centre; 🇨🇦 Ottawa, Ontario, Canada

West Park Healthcare Centre; 🇨🇦 Toronto, Ontario, Canada

School of Health Sciences, University of Aveiro; 🇵🇹 Aveiro, Portugal

James Cook University Hospital; 🇬🇧 Middlesbrough, North Yorkshire, United Kingdom