- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00781183
Does Pulmonary Rehabilitation Change Self-Selected And Maximum Sustainable Walking Speed In Patients With Lung Disease?
Does Pulmonary Rehabilitation Change The Self-Selected And Maximum Sustainable Walking Speed In Patients With Symptomatic Lung Disease?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: Pulmonary rehabilitation (PR) is considered a standard of care for patients with symptomatic lung disease. It has achieved strong evidence for reducing symptoms and improving exercise tolerance. Walking is the most common form of physical activity and most individuals need to walk in the course of their daily activities. Chosen walking speed is a good indicator of the debilitating effects of disease and improvement in usual walk speed has been associated with a substantial reduction in mortality in elderly subjects. Therefore, it is important for clinicians to understand how patients choose to walk in relation to their capabilities as well as to know how this relationship changes with PR.
The main purpose of this study is to examine the relationship between walking speed and walking endurance before and after PR.
Primary aim: to estimate the maximum walking speed that can be sustained for > 24 min (i.e. maximum sustainable walking speed; MSWS) from the relationship between walking speed and walking time in patients with symptomatic lung disease.
Secondary aims: (i) to determine if chosen speed during the endurance walk test is different from the MSWS, (ii) to determine if MSWS and speed chosen for the endurance walk test changes in response to PR and, (iii) to measure the repeatability of endurance walk time (EWT), defined as the duration a patient can walk at a self-selected pace before that first need to stop and rest.
Significance: Walking is the most common form of physical activity. Chosen walking speed and the capacity to endure walking at different speeds can help quantify disability. Also, studies that examine the effect of PR on survival are not available. However, indirect evidence suggests that PR improves many of the risk factors associated with mortality in patients with COPD. This study will examine the effect of PR on the usual walking speed selected by individuals with symptomatic lung disease, which has been demonstrated to be a predictor of mortality in elderly individuals. Therefore, our study may contribute to the indirect evidence for the effects of PR on survival.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients referred to pulmonary rehabilitation with symptomatic chronic lung disease
Exclusion Criteria:
- Co-morbid conditions that adversely affect exercise capacity or participation in a pulmonary rehabilitation program; inability to provide written informed consent; weaning doses of oral corticosteroids or methylxanthines
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pulmonary rehabilitation
patients that are enrolled in pulmonary rehabilitation
|
6-weeks of in-patient pulmonary rehabilitation or 12-weeks of out-patient pulmonary rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endurance walk time (EWT) defined as the time a patient can walk at a self-selected speed until they first need to stop and rest
Time Frame: Pre and post pulmonary rehabilitation
|
Pre and post pulmonary rehabilitation
|
The maximum sustainable walk speed (MSWS) defined as the maximum speed that a patient walk for at for > 24 minutes
Time Frame: Pre and post pulmonary rehabilitation
|
Pre and post pulmonary rehabilitation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dolmage TE, Evans RA, Hill K, Blouin M, Brooks D, Goldstein RS. The effect of pulmonary rehabilitation on critical walk speed in patients with COPD: a comparison with self-paced walks. Chest. 2012 Feb;141(2):413-419. doi: 10.1378/chest.11-1059. Epub 2011 Jul 21.
- Evans RA, Hill K, Dolmage TE, Blouin M, O'Hoski S, Brooks D, Goldstein RS. Properties of self-paced walking in chronic respiratory disease: a patient goal-oriented assessment. Chest. 2011 Sep;140(3):737-743. doi: 10.1378/chest.10-3104. Epub 2011 Mar 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6255L00002
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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