Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
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ClinicalTrials.gov Identifier: NCT02673242 |
Recruitment Status :
Completed
First Posted : February 3, 2016
Last Update Posted : April 27, 2017
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Sponsor:
Sykehuset Innlandet HF
Collaborator:
Bergen University College
Information provided by (Responsible Party):
Sykehuset Innlandet HF
Tracking Information | |||
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First Submitted Date ICMJE | February 1, 2016 | ||
First Posted Date ICMJE | February 3, 2016 | ||
Last Update Posted Date | April 27, 2017 | ||
Study Start Date ICMJE | November 2015 | ||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Maximal inspiratory pressure [ Time Frame: 6 weeks ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder | ||
Official Title ICMJE | Not Provided | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||
Intervention ICMJE | Device: Threshold IMT Philips Respironics
Inspiratory muscle training
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
3 | ||
Original Estimated Enrollment ICMJE |
20 | ||
Actual Study Completion Date ICMJE | August 2016 | ||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Norway | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02673242 | ||
Other Study ID Numbers ICMJE | E16260 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Responsible Party | Sykehuset Innlandet HF | ||
Study Sponsor ICMJE | Sykehuset Innlandet HF | ||
Collaborators ICMJE | Bergen University College | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Sykehuset Innlandet HF | ||
Verification Date | April 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |