- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895219
Physiotherapy and Dysfunctional Breathing (HVS)
May 7, 2009 updated by: Royal Brompton & Harefield NHS Foundation Trust
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
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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-
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London, United Kingdom, SW3 6NP
- Royal Brompton 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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of dysfunctional breathing (Nijmegen score of more than 23)
Exclusion Criteria:
- active metastatic disease
- osteoporotic disease
- dysfunctional breathing as a consequence of respiratory or cardiac disease
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: 1
Breathing re-training
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Breathing re-training
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Active Comparator: 2
Breathing re-training and musculoskeletal physiotherapy techniques
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nijmegen Questionnaire
Time Frame: 0, 2, 4, 8, 12 and 26 weeks
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0, 2, 4, 8, 12 and 26 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Six-minute walking test
Time Frame: 0, 2, 4, 8, 12 & 26 weeks
|
0, 2, 4, 8, 12 & 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Margaret E Hodson, MD, Royal Brompton & Harefield NHS Foundation Trust
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
July 1, 2007
Primary Completion (Anticipated)
July 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
May 7, 2009
First Submitted That Met QC Criteria
May 7, 2009
First Posted (Estimate)
May 8, 2009
Study Record Updates
Last Update Posted (Estimate)
May 8, 2009
Last Update Submitted That Met QC Criteria
May 7, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06/Q0404/64
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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