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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
Sponsor:
Collaborator:
Bergen University College
Information provided by (Responsible Party):
Sykehuset Innlandet HF

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Threshold IMT Philips Respironics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
No Intervention: Control
No treatment other than medical
Experimental: Intervention
Inspiratory muscle training
Device: Threshold IMT Philips Respironics
Inspiratory muscle training




Primary Outcome Measures :
  1. Maximal inspiratory pressure [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Six minute walk test [ Time Frame: 6 weeks ]
  2. Modified Medical Research Council Dyspnea Scale [ Time Frame: 6 weeks ]
  3. COPD Assessment Test [ Time Frame: 6 weeks ]
  4. Spirometry [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673242


Locations
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Norway
Sykehuset Innlandet Hospital Trust
Elverum, Norway, 2409
Sponsors and Collaborators
Sykehuset Innlandet HF
Bergen University College

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Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT02673242     History of Changes
Other Study ID Numbers: E16260
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive