- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478646
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea and Activity in Patients With COPD III-IV
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the treatment of COPD-Patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet.
Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system.
Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity.
The purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayern
-
Schönau, Bayern, Germany, 83471
- Schön Klinik Berchtesgadener Land
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inpatient rehabilitation
- COPD (Gold stage III and IV)
Exclusion Criteria:
- severe exacerbation in the last four weeks
- acute infections
- fever
- neuritides
- severe osteoporosis
- skin disease
- manic depression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conventional breathing therapy
first: conventional breathing therapy, second: reflectory breathing therapy
|
duration: 60 minutes.
|
|
Experimental: Reflectory breathing therapy
first: reflectory breathing therapy second: conventional breathing therapy
|
duration: 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BORG-Scale
Time Frame: Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
|
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea).
|
Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in residual volume
Time Frame: change from pre (minute 0) in residual volume at post (minute 60) intervention
|
measured by a portable spirometry device
|
change from pre (minute 0) in residual volume at post (minute 60) intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Klaus Kenn, Dr. med., Schön Klinik Berchtesgadener Land
- Principal Investigator: Stella Seeberg, University of Osnabrueck
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAT 2011
- KBerchtesgadener (Registry Identifier: KBerchtesgadener)
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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