NCT01930526

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

July 15, 2013

Last Update Submit

January 4, 2016

Conditions

Keywords

COPDExerciseCyclingSingle legPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

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

Interventions

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.

Pulmonary Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD referred for Pulmonary Rehabilitation

You may not qualify if:

  • Unstable cardiac disease
  • any neurological or orthopaedic condition that would make cycling difficult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Roger S Goldstein, MBChB

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respirologist

Study Record Dates

First Submitted

July 15, 2013

First Posted

August 29, 2013

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

October 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations