HyperventilationPhase 3HVSNCT00895219
Physiotherapy and Dysfunctional Breathing
A Phase 3 study testing Breathing re-training and Breathing re-training and musculoskeletal techniques in people with Hyperventilation, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperventilation
- What is being tested?
- Breathing re-training and Breathing re-training and musculoskeletal techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of dysfunctional breathing (Nijmegen score of more than 23)
Who cannot join
- active metastatic disease
- osteoporotic disease
- dysfunctional breathing as a consequence of respiratory or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effects of Respiratory Physiotherapy Alone and Respiratory Physiotherapy Combined With Musculoskeletal Techniques in the Management of Dysfunctional Breathing
Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.
- Conditions
- Hyperventilation
- Being tested
- Breathing re-training, Breathing re-training and musculoskeletal techniques
- Keywords
- Hyperventilation, Dysfunctional breathing, Physiotherapy, Musculoskeletal techniques
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing re-trainingOther
Breathing re-training
Breathing re-training and musculoskeletal techniquesOther
Breathing re-training and musculoskeletal physiotherapy techniques including mobilisation techniques to normalise muscle and joint restrictions, doming of the diaphragm to enhance contraction and relaxation, and rib raising to free restriction in rib cage motion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Breathing re-training Receives: Other: Breathing re-training |
| 2 | Active comparator | Breathing re-training and musculoskeletal physiotherapy techniques Receives: Other: Breathing re-training and musculoskeletal techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nijmegen Questionnaire
Measured: 0, 2, 4, 8, 12 and 26 weeks
Secondary outcomes (1)
Six-minute walking test
Measured: 0, 2, 4, 8, 12 & 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperventilationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Margaret E Hodson, MD, Study director, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895219
- Sponsor's protocol ID
- 06/Q0404/64
- Acronym
- HVS
- Status last verified
- Apr 2009
- First submitted
- 7 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Respiratory Physiotherapy Alone and Respiratory Physiotherapy Combined With Musculoskeletal Techniques in the Management of Dysfunctional Breathing
- ClinicalTrials.gov ID
- NCT00895219
- Acronym / sponsor ID
- HVS / 06/Q0404/64
- Conditions
- Hyperventilation
- Keywords
- Hyperventilation, Dysfunctional breathing, Physiotherapy, Musculoskeletal techniques
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 8 May 2009 (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.
Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Breathing re-trainingBreathing re-training |
| 2 | Active comparator | Other: Breathing re-training and musculoskeletal techniquesBreathing re-training and musculoskeletal physiotherapy techniques |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of dysfunctional breathing (Nijmegen score of more than 23)
Key exclusion criteria (3 listed)
- active metastatic disease
- osteoporotic disease
- dysfunctional breathing as a consequence of respiratory or cardiac disease
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 re-trainingBreathing re-training | Other | 1 |
| Breathing re-training and musculoskeletal techniquesBreathing re-training and musculoskeletal physiotherapy techniques including mobilisation techniques to normalise muscle and joint restrictions, doming of the diaphragm to enhance contraction and relaxation, and rib raising to free restriction in rib cage motion. | Other | 2 |
Primary outcome
Nijmegen Questionnaire
Time frame: 0, 2, 4, 8, 12 and 26 weeks
1 secondary outcome
Six-minute walking test
Time frame: 0, 2, 4, 8, 12 & 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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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.
Margaret E Hodson, MD study director
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breathing re-training and Breathing re-training and musculoskeletal techniques in people with Hyperventilation, run by Royal Brompton & Harefield NHS Foundation 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 May 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Nijmegen Questionnaire (time frame: 0, 2, 4, 8, 12 and 26 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 8 May 2009.