The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2

The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea, Activity and Parasympathetic Activities in Patients With COPD III-IV

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Procedure: conventional breathing therapy; Procedure: reflectory breathing therapy

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Schönau, Bayern, Germany, 83471
      • Recruiting
      • Schön Klinik Berchtesgadener Land
      • Contact: Klaus Kenn, Prof.; Phone Number: 1540 0049865293; Email: kkenn@schoen-kliniken.de
      • Contact: Tessa Schneeberger, MSc; Phone Number: 2730 0049865293; Email: tschneeberger@schoen-kliniken.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 0) in Borg Scale and directly post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lung volume	measured by a bodyplethysmograph	change from pre (minute0) in residual volume to post intervention
physical activity	measured by Senswear	48 h post intervention
parasympathetic activities	measured via Biofeedback	baseline and post intervention
Chronic Respiratory Questionnaire	health related quality of life	baseline and post intervention
COPD Assessment Test	health related Quality of life	baseline and post intervention

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Investigators: Study Chair: Klaus Kenn, Prof. Dr., Schön Klinik Berchtesgadener Land; Principal Investigator: Tessa Schneeberger, Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
• Other Study ID Numbers: RAT 2013; KBerchtesgadener (Registry Identifier: KBerchtesgadener)