NCT01905982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

3.9 years

First QC Date

July 19, 2013

Last Update Submit

June 17, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in lung volume

    change from pre (minute0) in residual volume to post intervention

  • physical activity

    48 h post intervention

  • parasympathetic activities

    baseline and post intervention

  • Chronic Respiratory Questionnaire

    baseline and post intervention

  • COPD Assessment Test

    baseline and post intervention

Study Arms (2)

Conventional breathing therapy

EXPERIMENTAL

first: conventional breathing therapy, second: reflectory breathing therapy

Procedure: conventional breathing therapy

Reflectory breathing therapy

EXPERIMENTAL

first: Reflectory breathing therapy second:Conventional breathing therapy

Procedure: reflectory breathing therapy

Interventions

reflectory breathing therapyPROCEDURE

duration:2x60 minutes

Reflectory breathing therapy
conventional breathing therapyPROCEDURE

duration:4x30 minutes

Conventional breathing therapy

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inpatient rehabilitation
  • COPD (Gold stage III and IV)

You may not qualify if:

  • severe exacerbation in the last four weeks
  • acute infections
  • fever
  • neuritides
  • severe osteoporosis
  • skin disease
  • manic depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau, Bavaria, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Klaus Kenn, Prof. Dr.

    Schön Klinik Berchtesgadener Land

    STUDY CHAIR

  • Tessa Schneeberger

    Schön Klinik Berchtesgadener Land

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician (department of pulmonology)

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

DE(1)