Back to resultsBalance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Balance training program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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).
Sites / Locations
- West Park Healthcare Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Balance Training
Usual care
Arm Description
The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation.
The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes.
Outcomes
Primary Outcome Measures
Berg Balance Scale
Balance Evaluation Systems Test
Secondary Outcome Measures
Balance confidence/falls self-efficacy
Functional strength
Self-reported physical function
Full Information
NCT ID
NCT01424098
First Posted
August 22, 2011
Last Updated
April 29, 2022
Sponsor
Roger Goldstein
Collaborators
Ontario Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT01424098
Brief Title
Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized Controlled Trial of Balance Training in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roger Goldstein
Collaborators
Ontario Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 chronic lung disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance Training
Arm Type
Experimental
Arm Description
The treatment group will complete a specific balance training program in addition to conventional pulmonary rehabilitation.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The control group will undergo the usual pulmonary rehabilitation program offered at our centre with no additional balance training classes.
Intervention Type
Behavioral
Intervention Name(s)
Balance training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Title
Balance Evaluation Systems Test
Time Frame
At baseline and 6 weeks.
Secondary Outcome Measure Information:
Title
Balance confidence/falls self-efficacy
Time Frame
At baseline and 6 weeks.
Title
Functional strength
Time Frame
At baseline and 6 weeks.
Title
Self-reported physical function
Time Frame
At baseline and 6 weeks.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Brooks, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein, MD
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marla K Beauchamp, MSc.PT
Organizational Affiliation
University of Toronto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tania Janaudis-Ferreira, PhD
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Study Chair
Facility Information:
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M2J5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23975185
Citation
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.
Results Reference
derived
Learn more about this trial
Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
We'll reach out to this number within 24 hrs