Balance Training for Fall Reduction in COPD

NCT ID: NCT02995681

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2022-03-31

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.

Conditions

Copd; Fall Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulmonary rehab and balance training

The intervention group will receive standard pulmonary rehab plus additional balance training.

Group Type: EXPERIMENTAL

Balance training

Intervention Type: OTHER

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

Intervention Type: OTHER

Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

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.

Group Type: ACTIVE_COMPARATOR

Pulmonary rehab

Intervention Type: OTHER

Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

Interventions

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.

Intervention Type: OTHER

Pulmonary rehab

Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

Teesside University

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

La Trobe University

OTHER

Sponsor Role: collaborator

Aveiro University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

West Park Healthcare Centre

OTHER

Sponsor Role: lead

Responsible Party

Roger Goldstein

Respirologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Brooks, PhD

Role: PRINCIPAL_INVESTIGATOR

West Park Healthcare Centre

Roger Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

West Park Healthcare Centre

Marla Beauchamp, PhD

Role: PRINCIPAL_INVESTIGATOR

West Park Healthcare Centre

Locations

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

Countries

Australia; Canada; Portugal; United Kingdom

References

Hao Q, Brooks D, Ellerton C, Goldstein R, Lee AL, Alison JA, Dechman G, Haines KJ, Harrison SL, Holland AE, Marques A, Spencer L, Stickland MK, Skinner EH, Camp PG, Ma J, Beauchamp MK. Pulmonary rehabilitation with balance training for fall reduction in chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2024 Aug 24;24(1):408. doi: 10.1186/s12890-024-03215-2.

Reference Type: DERIVED

PMID: 39182033 (View on PubMed)

Beauchamp MK, Brooks D, Ellerton C, Lee A, Alison J, Camp PG, Dechman G, Haines K, Harrison SL, Holland AE, Marques A, Moineddin R, Skinner EH, Spencer L, Stickland MK, Xie F, Goldstein RS. Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 20;6(11):e228. doi: 10.2196/resprot.8178.

Reference Type: DERIVED

PMID: 29158206 (View on PubMed)

Other Identifiers

16-018-WP

Identifier Type: -

Identifier Source: org_study_id