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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01903772
Other study ID # IMTCO
Secondary ID Schön Klinik BGL
Status Completed
Phase N/A
First received July 12, 2013
Last updated March 1, 2017
Start date April 2013
Est. completion date February 2017

Study information

Verified date March 2017
Source Klinikum Berchtesgadener Land der Schön-Kliniken
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date February 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients with COPD

- Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks

- Pi,max <60 centimeters of water or <50% of the predicted normal value

Exclusion Criteria:

- Major comorbidities preventing successful participation in an 8 week exercise training intervention

- use of non-invasive ventilation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory Muscle Training


Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau am Königssee Bayern

Sponsors (2)

Lead Sponsor Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken Katholieke Universiteit Leuven

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6-Minute walking distance change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary exercise capacity (constant work rate test) change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary maximal inspiratory pressure (PImax) change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary inspiratory muscle endurance capacity change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary dyspnea measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
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