Balance Training for Fall Reduction in COPD

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

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.

Study Overview

• Status: Terminated
• Conditions: Copd; Fall Patients
• Intervention / Treatment: Other: Balance training; Other: Pulmonary rehab

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 Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
    • Saint Albans, Victoria, Australia, 3021
      • Western Health
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 0L4
      • G.F. Macdonald Centre for Lung Health
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Pulmonary Rehab Program
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 4Z9
      • Colchester East Hants Health Authority
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8M2
      • Ottawa Hospital Rehabilitation Centre
    • Toronto, Ontario, Canada, M6M2J5
      • West Park Healthcare Centre
• Portugal
  • Aveiro, Portugal, 3810-193
    • School of Health Sciences, University of Aveiro
• United Kingdom
  • North Yorkshire
    • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
      • James Cook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary rehab and balance training; The intervention group will receive standard pulmonary rehab plus additional balance training.	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.; Other: Pulmonary rehab; Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.
Active Comparator: 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.	Other: Pulmonary rehab; Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls	Number of falls will be measured using monthly falls diaries	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	Clinical measure of balance	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Balance Evaluation Systems Test (BESTest)	Clinical measure of balance	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Activities Specific Balance Confidence Scale	Balance confidence questionnaire	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
30 Second Repeated Chair Stand Test	Functional lower body strength test	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Dyspnea Index	Descriptive measure of shortness of breath	Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
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

Collaborators and Investigators

• Sponsor: West Park Healthcare Centre
• Collaborators: University of British Columbia; University of Alberta; University of Toronto; University of Ottawa; Dalhousie University; University of Sydney; Teesside University; Aveiro University; La Trobe University
• Investigators: Principal Investigator: Dina Brooks, PhD, West Park Healthcare Centre; Principal Investigator: Roger Goldstein, MD, West Park Healthcare Centre; Principal Investigator: Marla Beauchamp, PhD, West Park Healthcare Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Balance training; Falls
• Other Study ID Numbers: 16-018-WP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO