- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930526
Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
January 4, 2016 updated by: Roger Goldstein, West Park Healthcare Centre
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with COPD referred for Pulmonary Rehabilitation
Exclusion Criteria:
- Unstable cardiac disease
- any neurological or orthopaedic condition that would make cycling difficult
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulmonary Rehabilitation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peak oxygen uptake achieved by incremental cycle ergometry
Time Frame: Measured at the end of an average of eight weeks of pulmonary rehabilitation compared to baseline
|
A full incremental cardiopulmonary exercise test will be performed on a cycle ergometer to symptom limitation with expiratory gas analysis.
|
Measured at the end of an average of eight weeks of pulmonary rehabilitation compared to baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roger S Goldstein, MBChB, 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
July 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
July 15, 2013
First Submitted That Met QC Criteria
August 23, 2013
First Posted (Estimate)
August 29, 2013
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JREB2011-12
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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