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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01478646
Other study ID # RAT 2011
Secondary ID KBerchtesgadener
Status Completed
Phase N/A
First received September 30, 2011
Last updated November 22, 2011
Start date August 2011
Est. completion date November 2011

Study information

Verified date November 2011
Source Klinikum Berchtesgadener Land der Schön-Kliniken
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
conventional breathing therapy
duration: 60 minutes.
reflectory breathing therapy
duration: 60 minutes.

Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau Bayern

Sponsors (2)

Lead Sponsor Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken University of Osnabrueck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in BORG-Scale 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) Yes
Secondary Change in residual volume measured by a portable spirometry device change from pre (minute 0) in residual volume at post (minute 60) intervention No
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