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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02673242
Other study ID # E16260
Secondary ID
Status Completed
Phase N/A
First received February 1, 2016
Last updated April 26, 2017
Start date November 2015
Est. completion date August 2016

Study information

Verified date April 2017
Source Sykehuset Innlandet HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled trial with the aim of evaluating the effect of homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The intervention group will train with threshold IMT for 6 weeks. The control group will not participate in any other training method or sham. Evaluation parameters are maximal inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research council dyspnea scale and spirometry.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- COPD grade III-IV,

- Inhabitant of Hedmark (Løten, Våler, Åsnes, Hamar, Elverum)

Exclusion Criteria:

- Undergoing exercise based physical therapy treatment,

- not able to do IMT physically or mentally

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Threshold IMT Philips Respironics
Inspiratory muscle training

Locations

Country Name City State
Norway Sykehuset Innlandet Hospital Trust Elverum

Sponsors (2)

Lead Sponsor Collaborator
Sykehuset Innlandet HF Bergen University College

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal inspiratory pressure 6 weeks
Secondary Six minute walk test 6 weeks
Secondary Modified Medical Research Council Dyspnea Scale 6 weeks
Secondary COPD Assessment Test 6 weeks
Secondary Spirometry 6 weeks
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