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Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD) (IMTCO)

Primary Purpose

COPD, Inspiratory Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with COPD
  • Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
  • Pi,max <60 centimeters of water or <50% of the predicted normal value

Exclusion Criteria:

  • Major comorbidities preventing successful participation in an 8 week exercise training intervention
  • use of non-invasive ventilation

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory Muscle Training

Sham Inspiratory Muscle Training

Arm Description

Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max

Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)

Outcomes

Primary Outcome Measures

6-Minute walking distance

Secondary Outcome Measures

exercise capacity (constant work rate test)
maximal inspiratory pressure (PImax)
inspiratory muscle endurance capacity
dyspnea
measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test

Full Information

First Posted
July 12, 2013
Last Updated
March 1, 2017
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01903772
Brief Title
Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
IMTCO
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Inspiratory Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max
Arm Title
Sham Inspiratory Muscle Training
Arm Type
Sham Comparator
Arm Description
Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Primary Outcome Measure Information:
Title
6-Minute walking distance
Time Frame
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary Outcome Measure Information:
Title
exercise capacity (constant work rate test)
Time Frame
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Title
maximal inspiratory pressure (PImax)
Time Frame
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Title
inspiratory muscle endurance capacity
Time Frame
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Title
dyspnea
Description
measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test
Time Frame
change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with COPD Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks Pi,max <60 centimeters of water or <50% of the predicted normal value Exclusion Criteria: Major comorbidities preventing successful participation in an 8 week exercise training intervention use of non-invasive ventilation
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
State/Province
Bayern
ZIP/Postal Code
83483
Country
Germany

12. IPD Sharing Statement

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Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

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