AsthmaNCT00400270
Breathing and Relaxation Exercises for Asthma: a Randomised Controlled Trial
A study testing Breathing and relaxation exercises: the Papworth Method in people with Asthma, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Breathing and relaxation exercises: the Papworth Method
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2004to Jan 2006
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- doctor diagnosed asthma, volunteers from the practice asthma database
- 16-70 years of age
- able to understand, speak and write English
- willing to give informed consent
- willing and able to attend the surgery for assessments and treatments
Who cannot join
- serious co-morbid conditions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bridge Cottage Surgery
Welwyn, Hertfordshire, AL6 9EF
About this study
Official title: A Physical Therapy Treatment for Adults Diagnosed With Asthma in Primary Care: a Randomised Controlled Trial
All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. Patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12 months.
Hypotheses:
- The PM of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care.
- Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.
- Respiratory function measurements would improve compared with the control group.
- Conditions
- Asthma
- Being tested
- Breathing and relaxation exercises: the Papworth Method
- Keywords
- Asthma, Randomised controlled trial, Breathing exercises, Relaxation exercises, Primary care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing and relaxation exercises: the Papworth MethodProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related Quality of Life as measured by the St George's Respiratory Questionnaire
Secondary outcomes (3)
Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.
Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire.
Respiratory measurements as measured by spirometry and capnography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startOct 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Welwyn Hatfield Primary Care Trust, University College, London
- Investigators
- Professor Robert West, PhD, Study director, Department of Epidemiology and Public Health, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400270
- Sponsor's protocol ID
- EC03660
- Status last verified
- Nov 2006
- First submitted
- 15 Nov 2006
- Last updated
- 28 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physical Therapy Treatment for Adults Diagnosed With Asthma in Primary Care: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00400270
- Acronym / sponsor ID
- EC03660
- Conditions
- Asthma
- Keywords
- Asthma, Randomised controlled trial, Breathing exercises, Relaxation exercises, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- Welwyn Hatfield Primary Care Trust, University College, London
- Study start
- Oct 2004
- Study completion
- Jan 2006
- First posted
- 16 Nov 2006 (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.
All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. Patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12 months.
Hypotheses:
- The PM of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care.
- Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.
- Respiratory function measurements would improve compared with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- doctor diagnosed asthma, volunteers from the practice asthma database
- 16-70 years of age
- able to understand, speak and write English
- willing to give informed consent
- willing and able to attend the surgery for assessments and treatments
Key exclusion criteria (1 listed)
- serious co-morbid conditions
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 |
|---|---|---|
| Breathing and relaxation exercises: the Papworth Method | Procedure or surgery | – |
Primary outcome
Health related Quality of Life as measured by the St George's Respiratory Questionnaire
3 secondary outcomes
Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.
Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire.
Respiratory measurements as measured by spirometry and capnography.
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 28 May 2015.
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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.
Professor Robert West, PhD study director
Department of Epidemiology and Public Health, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing and relaxation exercises: the Papworth Method in people with Asthma, run by University College London Hospitals 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 5 inclusion and 1 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 28 May 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.
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?
Health related Quality of Life as measured by the St George's Respiratory Questionnaire. 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 28 May 2015.