Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- West Park Healthcare Centre
- Enrollment
- 258
- Locations
- 10
- Primary Endpoint
- Number of falls
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pulmonary rehab and balance training
The intervention group will receive standard pulmonary rehab plus additional balance training.
Intervention: Balance training (Other)
Pulmonary rehab and balance training
The intervention group will receive standard pulmonary rehab plus additional balance training.
Intervention: Pulmonary rehab (Other)
Pulmonary rehab
The control group will receive pulmonary rehab only and a pulmonary rehab home program (walking and lower extremity resistance exercises) upon discharge from pulmonary. They will also receive the same monthly phone calls and three home visits at three, six and nine months to ensure proper technique and progression.
Intervention: Pulmonary rehab (Other)
Outcomes
Primary Outcomes
Number of falls
Time Frame: 12 months
Number of falls will be measured using monthly falls diaries
Secondary Outcomes
- Berg Balance Scale(Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months)
- Balance Evaluation Systems Test (BESTest)(Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months)
- Activities Specific Balance Confidence Scale(Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months)
- 30 Second Repeated Chair Stand Test(Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months)
- European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)(Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months)
Investigators
Roger Goldstein
Respirologist
West Park Healthcare Centre