Back to resultsInspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Threshold IMT Philips Respironics
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- Sykehuset Innlandet Hospital Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
No treatment other than medical
Inspiratory muscle training
Outcomes
Primary Outcome Measures
Maximal inspiratory pressure
Secondary Outcome Measures
Six minute walk test
Modified Medical Research Council Dyspnea Scale
COPD Assessment Test
Spirometry
Full Information
NCT ID
NCT02673242
First Posted
February 1, 2016
Last Updated
April 26, 2017
Sponsor
Sykehuset Innlandet HF
Collaborators
Bergen University College
1. Study Identification
Unique Protocol Identification Number
NCT02673242
Brief Title
Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Bergen University College
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment other than medical
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Inspiratory muscle training
Intervention Type
Device
Intervention Name(s)
Threshold IMT Philips Respironics
Intervention Description
Inspiratory muscle training
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Six minute walk test
Time Frame
6 weeks
Title
Modified Medical Research Council Dyspnea Scale
Time Frame
6 weeks
Title
COPD Assessment Test
Time Frame
6 weeks
Title
Spirometry
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sykehuset Innlandet Hospital Trust
City
Elverum
ZIP/Postal Code
2409
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
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