Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Exercise, Cycling, Single leg, Pulmonary Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Patients with COPD referred for Pulmonary Rehabilitation
Exclusion Criteria:
- Unstable cardiac disease
- any neurological or orthopaedic condition that would make cycling difficult
Sites / Locations
- West Park Healthcare Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Rehabilitation
Arm Description
Patients will undergo the usual pulmonary rehabilitation programme but instead of two-legged cycling they will undergo single leg cycling where they cycle with one leg for 10-15mins and then the other in the same session.
Outcomes
Primary Outcome Measures
Change in peak oxygen uptake achieved by incremental cycle ergometry
A full incremental cardiopulmonary exercise test will be performed on a cycle ergometer to symptom limitation with expiratory gas analysis.
Secondary Outcome Measures
Full Information
NCT ID
NCT01930526
First Posted
July 15, 2013
Last Updated
January 4, 2016
Sponsor
West Park Healthcare Centre
1. Study Identification
Unique Protocol Identification Number
NCT01930526
Brief Title
Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
Official Title
Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for patients with chronic lung disease (COPD). Patients can improve their shortness of breath, walking distance and quality of life. However, many patients do not improve their overall fitness. They are too breathless to train at a high enough intensity. In a laboratory training study, patients with COPD improved their overall fitness by using single leg cycling. Despite this knowledge, single leg cycling has not been used clinically. The objective of this project is to use and assess single leg cycling in a clinical setting. Single leg cycling can be incorporated into a clinical service (replacing traditional two legged cycling) as the predominant aerobic training strategy, resulting in improvements in cardio-respiratory fitness (peak oxygen uptake).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Exercise, Cycling, Single leg, Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Patients will undergo the usual pulmonary rehabilitation programme but instead of two-legged cycling they will undergo single leg cycling where they cycle with one leg for 10-15mins and then the other in the same session.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Pulmonary Rehabilitation (PR) is a short course 6-12 weeks of supervised exercise training and education for patients with COPD. This is part of their usual treatment. This study is replacing two-legged cycling with single leg training. Patients will have the usual PR outcome measures assessed but in addition will have a laboratory exercise test.
Primary Outcome Measure Information:
Title
Change in peak oxygen uptake achieved by incremental cycle ergometry
Description
A full incremental cardiopulmonary exercise test will be performed on a cycle ergometer to symptom limitation with expiratory gas analysis.
Time Frame
Measured at the end of an average of eight weeks of pulmonary rehabilitation compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with COPD referred for Pulmonary Rehabilitation
Exclusion Criteria:
Unstable cardiac disease
any neurological or orthopaedic condition that would make cycling difficult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein, MBChB
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26291542
Citation
Evans RA, Dolmage TE, Mangovski-Alzamora S, Romano J, O'Brien L, Brooks D, Goldstein RS. One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Ann Am Thorac Soc. 2015 Oct;12(10):1490-7. doi: 10.1513/AnnalsATS.201504-231OC.
Results Reference
derived
Learn more about this trial
Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
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