- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404831
An Evaluation of Web Based Pulmonary Rehabilitation (webbasedPR)
July 23, 2015 updated by: Dr Lorna Paul, University of Glasgow
An Evaluation of Web Based Pulmonary Rehabilitation- Pilot Study
The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a term used to describe a number of lung conditions characterised by irreversible damage to the airways causing airflow obstruction.
Pulmonary Rehabilitation (PR) is a broad programme that helps improve the health and well-being of people with breathing difficulties, most commonly COPD.
Participation in PR leads to improvements in exercise tolerance and functional ability, as well as a reducing breathlessness in everyday activities.
It is traditionally an outpatient programme based in a hospital or community setting run by a multidisciplinary team, and usually lead by physiotherapy and nursing staff.
Typically it includes a physical exercise programme, and advice and education on managing a chronic lung condition.
The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Airdrie, United Kingdom, ML60JS
- Monklands Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A diagnosis of COPD
- Suitable for participation in the NHS Lanarkshire PR programme
- Independently mobile
- Access to the internet in their own home
Exclusion Criteria:
- Unstable cardiac or other health problems which may prevent participation in study
- Under the age of 18
- Pregnant
- Unable to read/understand English
- Unwilling to be randomised into PR delivered via the hospital or internet
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional hospital-based PR
Class based pulmonary rehabilitation
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Participants allocated to this group will undertake hospital-based PR twice per week for 6 weeks in.
Participants attend PR classes and complete a circuit based exercise class.
The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group.
Following each class they will receive educational information about their condition.
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Experimental: Web-based PR
web-based pulmonary rehab
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Participants will undertake web-based PR twice/week for 6 weeks in their own home.
They will be given individual log-in details to access the website with access to exercises and education pages.
Participants will be provided with a standardised exercise programme at the start of the study.
The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group.
Participant log-ins and diaries will be monitored remotely and participants will be telephone at weeks 2 and 4 by their physiotherapist to discuss their progress and, at this time, exercises may be progressed by changing the level of difficulty/intensity.
This is done remotely by physiotherapy staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Shuttle Walk test at 6 weeks
Time Frame: 6 weeks
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analysis
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Chronic Disease Questionnaire at 6 weeks
Time Frame: 6 weeks
|
questionnaire
|
6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Hospital Anxiety and Depression Scale at 6 weeks
Time Frame: 6 weeks
|
6 weeks
|
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Change from baseline in Borg Breathlessness Scale at 6 weeks
Time Frame: 6 weeks
|
6 weeks
|
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Website evaluation questionnaire
Time Frame: 6 weeks
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questionnaire completed by Experimental Group only
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6 weeks
|
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Semi-structured telephone interviews
Time Frame: 6 weeks
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Qualitative interview conducted with Experimental Group only
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorna Paul, PhD, University of Glasgow
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 2, 2014
First Submitted That Met QC Criteria
March 26, 2015
First Posted (Estimate)
April 1, 2015
Study Record Updates
Last Update Posted (Estimate)
July 24, 2015
Last Update Submitted That Met QC Criteria
July 23, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L13099
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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