Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation

This study is currently recruiting participants.
Verified August 2013 by West Park Healthcare Centre
Sponsor:
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre
ClinicalTrials.gov Identifier:
NCT01930526
First received: July 15, 2013
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation

Resource links provided by NLM:


Further study details as provided by West Park Healthcare Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A full incremental cardiopulmonary exercise test will be performed on a cycle ergometer to symptom limitation with expiratory gas analysis.


Estimated Enrollment: 21
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Pulmonary Rehabilitation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930526

Contacts
Contact: Roger S Goldstein, MBChB RGoldstein@westpark.org
Contact: Julia Romano, MSc julia.romano@westpark.org

Locations
Canada, Ontario
West Park Healthcare Centre Recruiting
Toronto, Ontario, Canada, M6M 2J5
Contact: Roger S Goldstein, MBChB       roger.goldstein@westpark.org   
Contact: Julia Romano, MSc       julia.romano@westpark.org   
Principal Investigator: Roger S Goldstein, MBChB         
Sub-Investigator: Tom E Dolmage, MSc         
Sub-Investigator: Julia Romano, MSc         
Sub-Investigator: Rachael A Evans, MBChB         
Sub-Investigator: Suzanna Mangovski-alzamora, PT         
Sub-Investigator: Dina Brooks, PT, PhD         
Sponsors and Collaborators
West Park Healthcare Centre
Investigators
Principal Investigator: Roger S Goldstein, MBChB West Park Healthcare Centre
  More Information

No publications provided

Responsible Party: Roger Goldstein, Respirologist, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT01930526     History of Changes
Other Study ID Numbers: JREB2011-12
Study First Received: July 15, 2013
Last Updated: August 23, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by West Park Healthcare Centre:
COPD
Exercise
Cycling
Single leg
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014