Physiotherapy and Dysfunctional Breathing (HVS)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2009 | ||||
| Last Updated Date | May 7, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Nijmegen Questionnaire [ Time Frame: 0, 2, 4, 8, 12 and 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Six-minute walking test [ Time Frame: 0, 2, 4, 8, 12 & 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Physiotherapy and Dysfunctional Breathing | ||||
| Official Title ICMJE | A Comparison of the Effects of Respiratory Physiotherapy Alone and Respiratory Physiotherapy Combined With Musculoskeletal Techniques in the Management of Dysfunctional Breathing | ||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hyperventilation | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00895219 | ||||
| Other Study ID Numbers ICMJE | 06/Q0404/64 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Jennifer A Pryor, Royal Brompton & Harefield NHS Trust | ||||
| Study Sponsor ICMJE | Royal Brompton & Harefield NHS Foundation Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Royal Brompton & Harefield NHS Foundation Trust | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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