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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; part2

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ClinicalTrials.gov Identifier: NCT01905982
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: reflectory breathing therapy Procedure: conventional breathing therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional breathing therapy
first: conventional breathing therapy, second: reflectory breathing therapy
Procedure: conventional breathing therapy
duration:4x30 minutes

Experimental: Reflectory breathing therapy
first: Reflectory breathing therapy second:Conventional breathing therapy
Procedure: reflectory breathing therapy
duration:2x60 minutes




Primary Outcome Measures :
  1. Change in BORG-Scale [ Time Frame: Change from pre (minute 0) in Borg Scale and directly post intervention ]
    Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea)


Secondary Outcome Measures :
  1. Change in lung volume [ Time Frame: change from pre (minute0) in residual volume to post intervention ]
    measured by a bodyplethysmograph

  2. physical activity [ Time Frame: 48 h post intervention ]
    measured by Senswear

  3. parasympathetic activities [ Time Frame: baseline and post intervention ]
    measured via Biofeedback

  4. Chronic Respiratory Questionnaire [ Time Frame: baseline and post intervention ]
    health related quality of life

  5. COPD Assessment Test [ Time Frame: baseline and post intervention ]
    health related Quality of life



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905982


Locations
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Germany
Schön Klinik Berchtesgadener Land Recruiting
Schönau, Bayern, Germany, 83471
Contact: Klaus Kenn, Prof.    0049865293 ext 1540    kkenn@schoen-kliniken.de   
Contact: Tessa Schneeberger, MSc    0049865293 ext 2730    tschneeberger@schoen-kliniken.de   
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Investigators
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Study Chair: Klaus Kenn, Prof. Dr. Schön Klinik Berchtesgadener Land
Principal Investigator: Tessa Schneeberger Schön Klinik Berchtesgadener Land
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Responsible Party: Klaus Kenn, Head physician (department of pulmonology), Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT01905982    
Other Study ID Numbers: RAT 2013
KBerchtesgadener
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes