Clinical trial NCT02995681: Balance Training for Fall Reduction in COPD
Official title: Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Copd
Fall Patients
Keywords: COPD
Falls
Balance training
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Dalhousie University
name: University of Alberta
name: University of Ottawa
name: Teesside University
name: University of Sydney
name: La Trobe University
name: Aveiro University
name: University of Toronto
First posted: 2016-12-16
Enrollment: 258
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of falls
timeFrame: 12 months
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
measure: Activities Specific Balance Confidence Scale
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
measure: 30 Second Repeated Chair Stand Test
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
measure: European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months
Other outcomes:
measure: Baseline Dyspnea Index
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
measure: Falls Risk for Older People - Community Setting (FROP-Com)
timeFrame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Saint Albans
country: Australia
facility: Western Health
state: Victoria
city: Edmonton
country: Canada
facility: G.F. Macdonald Centre for Lung Health
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Pulmonary Rehab Program
state: British Columbia
city: Truro
country: Canada
facility: Colchester East Hants Health Authority
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital Rehabilitation Centre
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
city: Aveiro
country: Portugal
facility: School of Health Sciences, University of Aveiro
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: North Yorkshire
Study officials:
affiliation: West Park Healthcare Centre
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Park Healthcare Centre
name: Roger Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Park Healthcare Centre
name: Marla Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.