Chronic Obstructive Pulmonary DiseaseNCT01424098
Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Balance training program in people with Chronic Obstructive Pulmonary Disease, run by Roger Goldstein at 1 site in Canada.
Trial summary
A growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. The main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Balance training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Sep 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COPD; a self-report of decline in balance or fall in the last 5 years or a recent near fall; smoking history greater than 10 pack years; and are able to provide written informed consent.
Who cannot join
- Inability to communicate because of language skills, hearing or cognitive impairment; and evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Balance Training in Patients With Chronic Obstructive Pulmonary Disease
A growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. The main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with chronic lung disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Balance training program
- 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 training programBehavioural
Training will consist of 30 minute sessions 3 times/week for 6 weeks in keeping with best practice guidelines for older adults. Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training | Experimental | The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation. Receives: Behavioral: Balance training program |
| Usual care | No intervention | The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: All outcomes will be assessed upon admission to pulmonary rehabilitation (baseline) and again upon completion of the program, an expected average of 6 weeks from baseline.
Balance Evaluation Systems Test
Measured: At baseline and 6 weeks.
Secondary outcomes (3)
Balance confidence/falls self-efficacy
Measured: At baseline and 6 weeks.
Functional strength
Measured: At baseline and 6 weeks.
Self-reported physical function
Measured: At baseline and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Goldstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association
- Responsible party
- Sponsor-investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Dina Brooks, PhD, Principal investigator, University of TorontoRoger S Goldstein, MD, Principal investigator, West Park Healthcare CentreMarla K Beauchamp, MSc.PT, Study chair, University of TorontoTania Janaudis-Ferreira, PhD, Study chair, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424098
- Sponsor's protocol ID
- Goldstein_OTSBalanceRCT_2012
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2011
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.
PubMed 23975185
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Balance Training in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01424098
- Acronym / sponsor ID
- Goldstein_OTSBalanceRCT_2012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Roger GoldsteinUniversity, hospital or other
- Collaborators
- Ontario Lung Association
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Aug 2011 (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.
A growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. The main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with chronic lung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Experimental | Behavioral: Balance training programThe treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation. |
| Usual care | No intervention | –The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD; a self-report of decline in balance or fall in the last 5 years or a recent near fall; smoking history greater than 10 pack years; and are able to provide written informed consent.
Key exclusion criteria (1 listed)
- Inability to communicate because of language skills, hearing or cognitive impairment; and evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).
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 training programTraining will consist of 30 minute sessions 3 times/week for 6 weeks in keeping with best practice guidelines for older adults. Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression. | Behavioural | Balance Training |
Primary outcome
Berg Balance Scale
Time frame: All outcomes will be assessed upon admission to pulmonary rehabilitation (baseline) and again upon completion of the program, an expected average of 6 weeks from baseline.
Balance Evaluation Systems Test
Time frame: At baseline and 6 weeks.
3 secondary outcomes
Balance confidence/falls self-efficacy
Time frame: At baseline and 6 weeks.
Functional strength
Time frame: At baseline and 6 weeks.
Self-reported physical function
Time frame: At baseline and 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 23975185Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.
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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
University of Toronto
Roger S Goldstein, MD principal investigator
West Park Healthcare Centre
Marla K Beauchamp, MSc.PT study chair
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training program in people with Chronic Obstructive Pulmonary Disease, run by Roger Goldstein at 1 site in Canada.
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: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Scale (time frame: All outcomes will be assessed upon admission to pulmonary rehabilitation (baseline) and again upon completion of the program, an expected average of 6 weeks from baseline.). The study lists 2 primary outcomes in all. 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 NCT01424098, which also lists 1 linked publication.
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 3 May 2022.