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Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
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
 (submitted: February 2, 2016)
Maximal inspiratory pressure [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02673242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Six minute walk test [ Time Frame: 6 weeks ]
  • Modified Medical Research Council Dyspnea Scale [ Time Frame: 6 weeks ]
  • COPD Assessment Test [ Time Frame: 6 weeks ]
  • Spirometry [ Time Frame: 6 weeks ]
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
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE Device: Threshold IMT Philips Respironics
Inspiratory muscle training
Study Arms  ICMJE
  • No Intervention: Control
    No treatment other than medical
  • Experimental: Intervention
    Inspiratory muscle training
    Intervention: Device: Threshold IMT Philips Respironics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Plan to Share IPD: No
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