- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05820776
Tele-rehabilitation in Chronic Respiratory Disease: an Observational Cohort Study
July 25, 2024 updated by: Roger Goldstein, West Park Healthcare Centre
Remote Exercise-based Pulmonary Rehabilitation Telemedicine in Chronic Respiratory Disease: an Observational Cohort Study
Pulmonary rehabilitation is a program that helps people with lung disease improve their function.
It uses exercise, education, and self-management strategies to improve physical ability and quality of life.
Because some people are unable to visit West Park Healthcare Centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone).
Regular quality assurance is necessary to ensure that the program is effective.
We plan to collect and summarize the program's results.
The benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Office Supervisor
- Phone Number: 14162433631
Study Contact Backup
- Name: Research Assistant
- Phone Number: 2186 14162433600
- Email: diane.peterson@westpark.org
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- Recruiting
- West Park Healthcare Centre
-
Contact:
- Research Assistant
- Phone Number: 2186 14162433600
-
Contact:
- Office Supervisor
- Phone Number: 14162433631
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adults diagnosed with chronic respiratory disease affecting the airways and other structures of the lungs causing dyspnea including chronic obstructive pulmonary disease (COPD), occupational lung diseases and pulmonary hypertension.
Description
Inclusion Criteria:
- stable chronic respiratory disease
- qualified candidates for pulmonary rehabilitation,
- current non-smoker;
- primary diagnosis chronic respiratory disease limited by dyspnea (mMRC≥2);
- free of exacerbation at the time of admission, and
- stable co-existing conditions
Exclusion Criteria:
- completed PR within the previous 12 months of the current admission and
- being unable to communicate with the treating team.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
health-related quality of life Chronic Respiratory Questionnaire - dyspnea
Time Frame: 12 weeks
|
Disease-specific health-related quality of life questionnaire.
Developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute walk test distance
Time Frame: 12 weeks
|
An objective evaluation of functional exercise capacity; the subject is asked to walk as far as possible for 6 minutes.
|
12 weeks
|
|
30-second Chair Stand Test
Time Frame: 12 weeks
|
A measurement to assess functional leg strength and endurance by involves recording the number of stands a person can complete in 30 seconds
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roger Goldstein, MD, West Park Healthcare Centre
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 (Actual)
April 6, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
April 6, 2023
First Submitted That Met QC Criteria
April 6, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
July 26, 2024
Last Update Submitted That Met QC Criteria
July 25, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTR-RG2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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