- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080442
Balance Training for Chronic Obstructive Pulmonary Disease (COPD)
March 4, 2014 updated by: Samantha Harrison
Balance Training for COPD in Pulmonary Rehabilitation (PR): An Effectiveness Study
The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
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
-
Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Center
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with COPD enrolled in PR
Description
Inclusion Criteria:
- Diagnosis of COPD
- 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
- Are able to provide written informed consent.
Exclusion Criteria:
- An inability to communicate because of language skills, hearing or cognitive impairment
- 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic Obstructive Pulmonary Disease
|
Training will consist of 30 minute sessions 2-3 times/week for a total of 18-24 sessions, in keeping with best practice guidelines for older adults.12
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: at 6 weeks
|
The BBS was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
|
at 6 weeks
|
Timed Up and Go (TUG):
Time Frame: at 6 weeks
|
The TUG was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
|
at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Balance Evaluation Systems Test (BESTest)
Time Frame: at 6 weeks
|
The BESTest was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
|
at 6 weeks
|
Activity-specific Balance Confidence (ABC) Scale
Time Frame: at 6 weeks
|
The ABC scale was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
|
at 6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance training progression: the training prescription and progression will be recorded
Time Frame: at 6 weeks
|
at 6 weeks
|
|
Therapists' and the participants' satisfaction
Time Frame: at 6 weeks
|
Patients completed a questionnaire following completion of the balance training which took place thrice weekly for a period of 6 weeks. The focus group was conducted at the end of study recruitment. |
at 6 weeks
|
Safety: any adverse events associated with balance training will be recorded
Time Frame: at 6 weeks
|
at 6 weeks
|
|
Applicability and adherence
Time Frame: at 6 weeks
|
at 6 weeks
|
|
The Six-Minute Walk Test (6MWT)
Time Frame: at 6 weeks
|
The 6MWT was assessed by the physiotherapists responsible for delivering the PR program.
The PR programs runs over 6 weeks.
|
at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
May 1, 2013
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
March 3, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (ESTIMATE)
March 6, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 6, 2014
Last Update Submitted That Met QC Criteria
March 4, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-o11-WP
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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