Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00542932
The Effects of a Home Exercise Video Programme for Patients With COPD
A Phase 2 study testing Exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes in the form of pulmonary rehabilitation (PR) have been shown to improve both of these symptoms significantly. PR involves patients attending a hospital or community centre. For some patients, leaving the house is an ordeal. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Oct 2006
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate/severe COPD
- Access to a video or DVD player
Who cannot join
- Comorbid condition that precludes safe exercise
- Previous attendance at a pulmonary rehabilitation programme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Home Exercise Video Programme for Patients With Chronic Obstructive Pulmonary Disease:Pilot Study
Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes in the form of pulmonary rehabilitation (PR) have been shown to improve both of these symptoms significantly. PR involves patients attending a hospital or community centre. For some patients, leaving the house is an ordeal. This study investigated the effectiveness of an exercise video programme delivered in the patients home.
Read the detailed description
Pulmonary Rehabilitation (PR) has been shown to deliver cost-effective improvements in dyspnoea, exercise tolerance and health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD). PR programmes in the United Kingdom (UK) are typically delivered on an outpatient basis, either at a hospital or suitable site in the community. It is not always possible however, for patients to access outpatient programmes due to lack of local availability or adequate transport from isolated locations. Severe breathlessness may reduce activity levels to such a degree that for many leaving the house is an ordeal. A British Lung Foundation (BLF) survey reported that less than 2% of UK COPD patients had access to a rehabilitation exercise programme, despite National Institute for Health and Clinical Excellence (NICE) and British Thoracic Society (BTS) recommendations that PR be made available to all patients who are functionally limited by dyspnoea. Meeting the demand for PR remains a challenge.
Access to the benefits of PR may be broadened if effective exercise could be administered at home. Current evidence suggests that home-based rehabilitation interventions result in smaller benefits as judged by exercise tolerance and quality of life when compared to supervised programmes. The impact of home based rehabilitation may be limited by multiple factors including, lack of health care professional supervision and lack of support from fellow COPD sufferers. This lack of support may lead to poor adherence to prescribed exercise intensity and frequency in home programmes.
One-to-one supervision on an individual basis is unlikely to be feasible or cost-effective, however, use of a home exercise video could enhance adherence to prescribed exercise programmes. Video media can be an effective means of delivering exercise instruction. No published research to date has investigated the effectiveness of a home exercise video for patients with COPD. We hypothesised that an exercise programme based on video instruction at home, could improve walking ability, breathlessness and quality of life.
- Being tested
- Exercise
- Keywords
- COPD, Exercise, Home
- 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.
ExerciseOther
Watched Film A (promotional film)
Film B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home
| Study group | Role | What they receive |
|---|---|---|
| I | No intervention | Not described |
| II | Active comparator | Exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walk Test
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Chronic Respiratory Disease Questionnaire
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startOct 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brighton
- Investigators
- John Moxham, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542932
- Sponsor's protocol ID
- 05/Q0703/151
- Status last verified
- Oct 2007
- First submitted
- 11 Oct 2007
- Last updated
- 12 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Home Exercise Video Programme for Patients With Chronic Obstructive Pulmonary Disease:Pilot Study
- ClinicalTrials.gov ID
- NCT00542932
- Acronym / sponsor ID
- 05/Q0703/151
- Keywords
- COPD, Exercise, Home
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University of Brighton
- Study start
- Oct 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Oct 2007 (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.
Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes in the form of pulmonary rehabilitation (PR) have been shown to improve both of these symptoms significantly. PR involves patients attending a hospital or community centre. For some patients, leaving the house is an ordeal. This study investigated the effectiveness of an exercise video programme delivered in the patients home.
Detailed description
Pulmonary Rehabilitation (PR) has been shown to deliver cost-effective improvements in dyspnoea, exercise tolerance and health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD). PR programmes in the United Kingdom (UK) are typically delivered on an outpatient basis, either at a hospital or suitable site in the community. It is not always possible however, for patients to access outpatient programmes due to lack of local availability or adequate transport from isolated locations. Severe breathlessness may reduce activity levels to such a degree that for many leaving the house is an ordeal. A British Lung Foundation (BLF) survey reported that less than 2% of UK COPD patients had access to a rehabilitation exercise programme, despite National Institute for Health and Clinical Excellence (NICE) and British Thoracic Society (BTS) recommendations that PR be made available to all patients who are functionally limited by dyspnoea. Meeting the demand for PR remains a challenge.
Access to the benefits of PR may be broadened if effective exercise could be administered at home. Current evidence suggests that home-based rehabilitation interventions result in smaller benefits as judged by exercise tolerance and quality of life when compared to supervised programmes. The impact of home based rehabilitation may be limited by multiple factors including, lack of health care professional supervision and lack of support from fellow COPD sufferers. This lack of support may lead to poor adherence to prescribed exercise intensity and frequency in home programmes.
One-to-one supervision on an individual basis is unlikely to be feasible or cost-effective, however, use of a home exercise video could enhance adherence to prescribed exercise programmes. Video media can be an effective means of delivering exercise instruction. No published research to date has investigated the effectiveness of a home exercise video for patients with COPD. We hypothesised that an exercise programme based on video instruction at home, could improve walking ability, breathlessness and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | No intervention | – |
| II | Active comparator | Other: ExerciseExercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate/severe COPD
- Access to a video or DVD player
Key exclusion criteria (2 listed)
- Comorbid condition that precludes safe exercise
- Previous attendance at a pulmonary rehabilitation programme
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 |
|---|---|---|
| ExerciseWatched Film A (promotional film) Film B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home | Other | II |
Primary outcome
Incremental Shuttle Walk Test
Time frame: Baseline and 6 weeks
1 secondary outcome
Chronic Respiratory Disease Questionnaire
Time frame: Baseline and 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 12 Oct 2007.
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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.
John Moxham principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by King's College Hospital NHS Trust 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 2 inclusion and 2 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 12 Oct 2007. 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 phase mean?
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?
Incremental Shuttle Walk Test (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2007.