Back to resultsThe Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
reflectory breathing therapy
conventional breathing therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Schön Klinik Berchtesgadener LandRecruiting
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 lung volume
measured by a bodyplethysmograph
physical activity
measured by Senswear
parasympathetic activities
measured via Biofeedback
Chronic Respiratory Questionnaire
health related quality of life
COPD Assessment Test
health related Quality of life
Full Information
NCT ID
NCT01905982
First Posted
July 19, 2013
Last Updated
June 17, 2019
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT01905982
Brief Title
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2
Official Title
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea, Activity and Parasympathetic Activities in Patients With COPD III-IV
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
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, increase activity and have impact on parasympathetic activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
44 (Anticipated)
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
Procedure
Intervention Name(s)
reflectory breathing therapy
Intervention Description
duration:2x60 minutes
Intervention Type
Procedure
Intervention Name(s)
conventional breathing therapy
Intervention Description
duration:4x30 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 0) in Borg Scale and directly post intervention
Secondary Outcome Measure Information:
Title
Change in lung volume
Description
measured by a bodyplethysmograph
Time Frame
change from pre (minute0) in residual volume to post intervention
Title
physical activity
Description
measured by Senswear
Time Frame
48 h post intervention
Title
parasympathetic activities
Description
measured via Biofeedback
Time Frame
baseline and post intervention
Title
Chronic Respiratory Questionnaire
Description
health related quality of life
Time Frame
baseline and post intervention
Title
COPD Assessment Test
Description
health related Quality of life
Time Frame
baseline and post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 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, Prof. Dr.
Organizational Affiliation
Schön Klinik Berchtesgadener Land
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tessa Schneeberger
Organizational Affiliation
Schön Klinik Berchtesgadener Land
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau
State/Province
Bayern
ZIP/Postal Code
83471
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof.
Phone
0049865293
Ext
1540
Email
kkenn@schoen-kliniken.de
First Name & Middle Initial & Last Name & Degree
Tessa Schneeberger, MSc
Phone
0049865293
Ext
2730
Email
tschneeberger@schoen-kliniken.de
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; part2
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