NCT01478646

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

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

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

September 30, 2011

Last Update Submit

November 22, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

breathing therapyreflective breathing therapyCOPDchronic 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 o) in BORG-scale at directly post intervention (minute 60)

Secondary Outcomes (1)

  • Change in residual volume

    change from pre (minute 0) in residual volume at post (minute 60) intervention

Study Arms (2)

Conventional breathing therapy

EXPERIMENTAL

first: conventional breathing therapy, second: reflectory breathing therapy

Other: conventional breathing therapy

Reflectory breathing therapy

EXPERIMENTAL

first: reflectory breathing therapy second: conventional breathing therapy

Other: reflectory breathing therapy

Interventions

conventional breathing therapyOTHER

duration: 60 minutes.

Conventional breathing therapy
reflectory breathing therapyOTHER

duration: 60 minutes.

Reflectory breathing therapy

Eligibility Criteria

Age45 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

Location

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, Dr. med.

    Schön Klinik Berchtesgadener Land

    STUDY CHAIR

  • Stella Seeberg

    University of Osnabrueck

    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

September 30, 2011

First Posted

November 23, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

DE(1)