Chronic Obstructive Pulmonary DiseasePhase 1/2webbasedPRNCT02404831
An Evaluation of Web Based Pulmonary Rehabilitation
A Phase 1/2 study testing Web-based PR and Hospital-based PR in people with Chronic Obstructive Pulmonary Disease, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Web-based PR and Hospital-based PR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD
- Suitable for participation in the NHS Lanarkshire PR programme
- Independently mobile
- Access to the internet in their own home
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Web-based PR, Hospital-based PR
- Keywords
- Physiotherapy, Pulmonary Rehabilitation, Exercise, Telerehab
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based PROther
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.
Hospital-based PROther
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional hospital-based PR | Active comparator | Class based pulmonary rehabilitation Receives: Other: Hospital-based PR |
| Web-based PR | Experimental | web-based pulmonary rehab Receives: Other: Web-based PR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Shuttle Walk test at 6 weeks
analysis
Measured: 6 weeks
Secondary outcomes (1)
Change from baseline in Chronic Disease Questionnaire at 6 weeks
questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Research and Development
- Responsible party
- Principal investigator, Dr Lorna Paul, University of Glasgow
- Investigators
- Lorna Paul, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404831
- Sponsor's protocol ID
- L13099
- Acronym
- webbasedPR
- Status last verified
- Jul 2015
- First submitted
- 2 Dec 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Web Based Pulmonary Rehabilitation- Pilot Study
- ClinicalTrials.gov ID
- NCT02404831
- Acronym / sponsor ID
- webbasedPR / L13099
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Physiotherapy, Pulmonary Rehabilitation, Exercise, Telerehab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Research and Development
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional hospital-based PR | Active comparator | Other: Hospital-based PRClass based pulmonary rehabilitation |
| Web-based PR | Experimental | Other: Web-based PRweb-based pulmonary rehab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of COPD
- Suitable for participation in the NHS Lanarkshire PR programme
- Independently mobile
- Access to the internet in their own home
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based PRParticipants 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. | Other | Web-based PR |
| Hospital-based PRParticipants 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. | Other | Traditional hospital-based PR |
Primary outcome
Change from baseline in Shuttle Walk test at 6 weeks
Time frame: 6 weeks
analysis
1 secondary outcome
Change from baseline in Chronic Disease Questionnaire at 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Paul, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Web-based PR and Hospital-based PR in people with Chronic Obstructive Pulmonary Disease, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Shuttle Walk test at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.