CopdNCT02995681
Balance Training for Fall Reduction in COPD
A study testing Balance training and Pulmonary rehab in people with Copd and Fall Patients, run by West Park Healthcare Centre at 10 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd, Fall Patients
- What is being tested?
- Balance training and Pulmonary rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Jan 2017to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Canada5 sites
G.F. Macdonald Centre for Lung Health
Edmonton, Alberta, T5K 0L4
Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
West Park Healthcare Centre
Toronto, Ontario, M6M2J5
Colchester East Hants Health Authority
Truro, Nova Scotia, B2N 4Z9
St. Paul's Pulmonary Rehab Program
Vancouver, British Columbia, V6Z 1Y6
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Alfred Health
Melbourne, Victoria, 3004
Western Health
Saint Albans, Victoria, 3021
Portugal1 site
School of Health Sciences, University of Aveiro
Aveiro, 3810-193
United Kingdom1 site
James Cook University Hospital
Middlesbrough, North Yorkshire, TS4 3BW
About this study
Official title: 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.
Read the 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
- Being tested
- Balance training, Pulmonary rehab
- Keywords
- COPD, Falls, Balance training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.
Pulmonary rehabOther
Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehab and balance training | Experimental | The intervention group will receive standard pulmonary rehab plus additional balance training. Receives: Other: Balance training; Other: Pulmonary rehab |
| Pulmonary rehab | Active comparator | 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. Receives: Other: Pulmonary rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls
Number of falls will be measured using monthly falls diaries
Measured: 12 months
Secondary outcomes (5)
Berg Balance Scale
Clinical measure of balance
Measured: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Balance Evaluation Systems Test (BESTest)
Clinical measure of balance
Measured: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Activities Specific Balance Confidence Scale
Balance confidence questionnaire
Measured: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
30 Second Repeated Chair Stand Test
Functional lower body strength test
Measured: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)
Health status questionnaire
Measured: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2022
- Study completionMar 2022
Why it stopped: COVID-19 pandemic restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Dalhousie University, University of Alberta, University of Ottawa, Teesside University, University of Sydney, La Trobe University, Aveiro University, University of Toronto
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Dina Brooks, PhD, Principal investigator, West Park Healthcare CentreRoger Goldstein, MD, Principal investigator, West Park Healthcare CentreMarla Beauchamp, PhD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995681
- Sponsor's protocol ID
- 16-018-WP
- Status last verified
- May 2023
- First submitted
- 14 Dec 2016
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nguyen KT, Brooks D, Macedo LG, Ellerton C, Goldstein RS, Alison J, Dechman G, Harrison S, Holland AE, Lee A, Marques A, Spencer L, Stickland MK, Skinner EH, Haines KJ, Beauchamp MK. Development of a clinical prediction model for falls in individuals with COPD. BMJ Open Respir Res. 2025 Dec 25;12(1):e002556. doi: 10.1136/bmjresp-2024-002556.
PubMed 41448796Alrabbaie H, Beauchamp M, Ellerton C, Goldstein R, Lee AL, Alison JA, Dechman G, Haines KJ, Harrison SL, Holland AE, Marques A, Spencer L, Stickland MK, Skinner EH, Brooks D. Determinants of balance impairment in individuals with Chronic Obstructive Pulmonary Disease: A secondary analysis of a randomized controlled trial. Respir Med. 2025 Dec;250:108537. doi: 10.1016/j.rmed.2025.108537. Epub 2025 Nov 25.
PubMed 41308797Hao 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.
PubMed 39182033Beauchamp 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.
PubMed 29158206
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD
- ClinicalTrials.gov ID
- NCT02995681
- Acronym / sponsor ID
- 16-018-WP
- Conditions
- Copd, Fall Patients
- Keywords
- COPD, Falls, Balance training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic restrictions
- Enrolment
- 258 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- University of British Columbia, Dalhousie University, University of Alberta, University of Ottawa, Teesside University, University of Sydney, La Trobe University, Aveiro University, University of Toronto
- Study start
- Jan 2017
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehab and balance training | Experimental | Other: Balance training, Other: Pulmonary rehabThe intervention group will receive standard pulmonary rehab plus additional balance training. |
| Pulmonary rehab | Active comparator | Other: Pulmonary rehabThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance trainingBalance 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 and balance training |
| Pulmonary rehabPulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support. | Other | Pulmonary rehab, Pulmonary rehab and balance training |
Primary outcome
Number of falls
Time frame: 12 months
Number of falls will be measured using monthly falls diaries
5 secondary outcomes
Berg Balance Scale
Time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Balance Evaluation Systems Test (BESTest)
Time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Activities Specific Balance Confidence Scale
Time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
30 Second Repeated Chair Stand Test
Time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)
Time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months
Results and safety
The study was stopped early (reason given: COVID-19 pandemic restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Derived from this study: PubMed 41448796Nguyen KT, Brooks D, Macedo LG, Ellerton C, Goldstein RS, Alison J, Dechman G, Harrison S, Holland AE, Lee A, Marques A, Spencer L, Stickland MK, Skinner EH, Haines KJ, Beauchamp MK. Development of a clinical prediction model for falls in individuals with COPD. BMJ Open Respir Res. 2025 Dec 25;12(1):e002556. doi: 10.1136/bmjresp-2024-002556.
- Derived from this study: PubMed 41308797Alrabbaie H, Beauchamp M, Ellerton C, Goldstein R, Lee AL, Alison JA, Dechman G, Haines KJ, Harrison SL, Holland AE, Marques A, Spencer L, Stickland MK, Skinner EH, Brooks D. Determinants of balance impairment in individuals with Chronic Obstructive Pulmonary Disease: A secondary analysis of a randomized controlled trial. Respir Med. 2025 Dec;250:108537. doi: 10.1016/j.rmed.2025.108537. Epub 2025 Nov 25.
- Derived from this study: PubMed 39182033Hao 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.
- Derived from this study: PubMed 29158206Beauchamp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Brooks, PhD principal investigator
West Park Healthcare Centre
Roger Goldstein, MD principal investigator
West Park Healthcare Centre
Marla Beauchamp, PhD principal investigator
West Park Healthcare Centre
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training and Pulmonary rehab in people with Copd and Fall Patients, run by West Park Healthcare Centre at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Australia, Portugal, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic restrictions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995681, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.