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Balance Training for Fall Reduction in COPD

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02995681
Enrollment
258
Registered
2016-12-16
Start date
2017-01-31
Completion date
2022-03-31
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd, Fall Patients

Keywords

COPD, Falls, Balance training

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.

Interventions

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

Sponsors

University of British Columbia
CollaboratorOTHER
Dalhousie University
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
University of Ottawa
CollaboratorOTHER
Teesside University
CollaboratorOTHER
University of Sydney
CollaboratorOTHER
La Trobe University
CollaboratorOTHER
Aveiro University
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
West Park Healthcare Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Number of falls12 monthsNumber of falls will be measured using monthly falls diaries

Secondary

MeasureTime frameDescription
Berg Balance ScaleBaseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsClinical measure of balance
Balance Evaluation Systems Test (BESTest)Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsClinical measure of balance
Activities Specific Balance Confidence ScaleBaseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsBalance confidence questionnaire
30 Second Repeated Chair Stand TestBaseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsFunctional 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 monthsHealth status questionnaire

Other

MeasureTime frameDescription
Baseline Dyspnea IndexBaseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsDescriptive measure of shortness of breath
Falls Risk for Older People - Community Setting (FROP-Com)Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 monthsDescriptive measure of falls risk in community dwelling older people

Countries

Australia, Canada, Portugal, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026