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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930526
Other study ID # JREB2011-12
Secondary ID
Status Completed
Phase N/A
First received July 15, 2013
Last updated January 4, 2016
Start date July 2011
Est. completion date October 2015

Study information

Verified date January 2016
Source West Park Healthcare Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health CanadaCanada: Ministry of Health & Long Term Care, Ontario
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 2015
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada West Park Healthcare Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measured at the end of an average of eight weeks of pulmonary rehabilitation compared to baseline No
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