Balance Training for Fall Reduction in COPD

Copd Clinical Trial

Official title:

Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02995681
• Other study ID #: 16-018-WP
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 2022

Study information

• Verified date: May 2023
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 258
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Copd
• Fall Patients

Intervention

Other:
• Balance training
Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.
• Pulmonary rehab
Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	Western Health	Saint Albans	Victoria
Canada	G.F. Macdonald Centre for Lung Health	Edmonton	Alberta
Canada	Ottawa Hospital Rehabilitation Centre	Ottawa	Ontario
Canada	West Park Healthcare Centre	Toronto	Ontario
Canada	Colchester East Hants Health Authority	Truro	Nova Scotia
Canada	St. Paul's Pulmonary Rehab Program	Vancouver	British Columbia
Portugal	School of Health Sciences, University of Aveiro	Aveiro
United Kingdom	James Cook University Hospital	Middlesbrough	North Yorkshire

Sponsors (10)

Lead Sponsor	Collaborator
West Park Healthcare Centre	Aveiro University, Dalhousie University, La Trobe University, Teesside University, University of Alberta, University of British Columbia, University of Ottawa, University of Sydney, University of Toronto

Countries where clinical trial is conducted

Australia,  Canada,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline Dyspnea Index	Descriptive measure of shortness of breath	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Other	Falls Risk for Older People - Community Setting (FROP-Com)	Descriptive measure of falls risk in community dwelling older people	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Primary	Number of falls	Number of falls will be measured using monthly falls diaries	12 months
Secondary	Berg Balance Scale	Clinical measure of balance	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary	Balance Evaluation Systems Test (BESTest)	Clinical measure of balance	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary	Activities Specific Balance Confidence Scale	Balance confidence questionnaire	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary	30 Second Repeated Chair Stand Test	Functional lower body strength test	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary	European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)	Health status questionnaire	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months