Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder

• ClinicalTrials.gov Identifier: NCT02673242
• Recruitment Status: Completed
• First Posted: February 3, 2016
• Last Update Posted: April 27, 2017
• Sponsor: Sykehuset Innlandet HF
• Collaborator: Bergen University College
• Information provided by (Responsible Party): Sykehuset Innlandet HF

Tracking Information

• First Submitted Date: February 1, 2016
• First Posted Date: February 3, 2016
• Last Update Posted Date: April 27, 2017
• Study Start Date: November 2015
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 2, 2016): Maximal inspiratory pressure [ Time Frame: 6 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02673242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pulmonary Disease, Chronic Obstructive

Intervention

Device: Threshold IMT Philips Respironics

Inspiratory muscle training

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 26, 2017): 3
• Original Estimated Enrollment (submitted: February 2, 2016): 20
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT02673242
• Other Study ID Numbers: E16260
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sykehuset Innlandet HF
• Study Sponsor: Sykehuset Innlandet HF
• Collaborators: Bergen University College
• Investigators: Not Provided
• PRS Account: Sykehuset Innlandet HF
• Verification Date: April 2017