Physiotherapy and Dysfunctional Breathing (HVS)
Primary Purpose
Hyperventilation
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Breathing re-training
Breathing re-training and musculoskeletal techniques
Sponsored by
About this trial
This is an interventional treatment trial for Hyperventilation focused on measuring Hyperventilation, Dysfunctional breathing, Physiotherapy, Musculoskeletal techniques
Eligibility Criteria
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
Sites / Locations
- Royal Brompton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Breathing re-training
Breathing re-training and musculoskeletal physiotherapy techniques
Outcomes
Primary Outcome Measures
Nijmegen Questionnaire
Secondary Outcome Measures
Six-minute walking test
Full Information
NCT ID
NCT00895219
First Posted
May 7, 2009
Last Updated
May 7, 2009
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00895219
Brief Title
Physiotherapy and Dysfunctional Breathing
Acronym
HVS
Official Title
A Comparison of the Effects of Respiratory Physiotherapy Alone and Respiratory Physiotherapy Combined With Musculoskeletal Techniques in the Management of Dysfunctional Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperventilation
Keywords
Hyperventilation, Dysfunctional breathing, Physiotherapy, Musculoskeletal techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Breathing re-training
Arm Title
2
Arm Type
Active Comparator
Arm Description
Breathing re-training and musculoskeletal physiotherapy techniques
Intervention Type
Other
Intervention Name(s)
Breathing re-training
Intervention Description
Breathing re-training
Intervention Type
Other
Intervention Name(s)
Breathing re-training and musculoskeletal techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nijmegen Questionnaire
Time Frame
0, 2, 4, 8, 12 and 26 weeks
Secondary Outcome Measure Information:
Title
Six-minute walking test
Time Frame
0, 2, 4, 8, 12 & 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret E Hodson, MD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy and Dysfunctional Breathing
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