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The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conventional breathing therapy
reflectory breathing therapy
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring breathing therapy, reflective breathing therapy, COPD, chronic obstructive pulmonary disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional breathing therapy

Reflectory breathing therapy

Arm Description

first: conventional breathing therapy, second: reflectory breathing therapy

first: reflectory breathing therapy second: conventional breathing therapy

Outcomes

Primary Outcome Measures

Change in BORG-Scale
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea).

Secondary Outcome Measures

Change in residual volume
measured by a portable spirometry device

Full Information

First Posted
September 30, 2011
Last Updated
November 22, 2011
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
University of Osnabrueck
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1. Study Identification

Unique Protocol Identification Number
NCT01478646
Brief Title
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV
Official Title
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea and Activity in Patients With COPD III-IV
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
University of Osnabrueck

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
breathing therapy, reflective breathing therapy, COPD, chronic obstructive pulmonary disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional breathing therapy
Arm Type
Experimental
Arm Description
first: conventional breathing therapy, second: reflectory breathing therapy
Arm Title
Reflectory breathing therapy
Arm Type
Experimental
Arm Description
first: reflectory breathing therapy second: conventional breathing therapy
Intervention Type
Other
Intervention Name(s)
conventional breathing therapy
Intervention Description
duration: 60 minutes.
Intervention Type
Other
Intervention Name(s)
reflectory breathing therapy
Intervention Description
duration: 60 minutes.
Primary Outcome Measure Information:
Title
Change in BORG-Scale
Description
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea).
Time Frame
Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
Secondary Outcome Measure Information:
Title
Change in residual volume
Description
measured by a portable spirometry device
Time Frame
change from pre (minute 0) in residual volume at post (minute 60) intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr. med.
Organizational Affiliation
Schön Klinik Berchtesgadener Land
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stella Seeberg
Organizational Affiliation
University of Osnabrueck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau
State/Province
Bayern
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV

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