- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424098
Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
April 29, 2022 updated by: Roger Goldstein
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M6M2J5
- West Park Healthcare Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Balance Training
The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation.
|
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.
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No Intervention: Usual care
The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
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Balance Evaluation Systems Test
Time Frame: At baseline and 6 weeks.
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At baseline and 6 weeks.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Balance confidence/falls self-efficacy
Time Frame: At baseline and 6 weeks.
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At baseline and 6 weeks.
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Functional strength
Time Frame: At baseline and 6 weeks.
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At baseline and 6 weeks.
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Self-reported physical function
Time Frame: At baseline and 6 weeks.
|
At baseline and 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dina Brooks, PhD, University of Toronto
- Study Chair: Marla K Beauchamp, MSc.PT, University of Toronto
- Study Chair: Tania Janaudis-Ferreira, PhD, West Park Healthcare Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
August 22, 2011
First Submitted That Met QC Criteria
August 24, 2011
First Posted (Estimate)
August 26, 2011
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
April 29, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Goldstein_OTSBalanceRCT_2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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