Inspiratory Muscle Training in Hypercapnic COPD

August 18, 2006 updated by: Krankenhaus Kloster Grafschaft

Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD

The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.

During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schmallenberg, Germany, 57392
        • Recruiting
        • Fachkrankenhaus Kloster Grafschaft
        • Principal Investigator:
          • Dominic Dellweg, M.D.
        • Contact:
        • Sub-Investigator:
          • Karina Reissig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD with FEV1/FVC < 70 %
  • age > 18
  • stable disease
  • able to walk
  • carbon dioxide >= 48 mmHg

Exclusion Criteria:

  • ejection fraction of the heart < 40 %
  • active psychiatric disease
  • bronchial hyperresponsiveness according to ATS criteria
  • pregnancy
  • renal insufficiency with a creatinine < 2 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
inspiratory muscle strength
inspiratory muscle endurance
walking distance with dyspnea score
Carbon dioxide level

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Kloster Grafschaft

Investigators

  • Principal Investigator: Dominic Dellweg, M.D., FKKG
  • Study Chair: Dieter Koehler, Prof. Dr., FKKG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

March 1, 2008

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (Estimate)

February 14, 2006

Study Record Updates

Last Update Posted (Estimate)

August 21, 2006

Last Update Submitted That Met QC Criteria

August 18, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKKG IMT 0106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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