NCT00291460

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 21, 2006

Status Verified

February 1, 2006

First QC Date

February 13, 2006

Last Update Submit

August 18, 2006

Conditions

COPDRespiratory Failure

Keywords

COPDrespiratory failureinspiratory muscle training

Outcome Measures

Primary Outcomes (4)

  • inspiratory muscle strength

  • inspiratory muscle endurance

  • walking distance with dyspnea score

  • Carbon dioxide level

Interventions

inspiratory muscle trainingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, 57392, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • Dominic Dellweg, M.D.

    FKKG

    PRINCIPAL INVESTIGATOR

  • Dieter Koehler, Prof. Dr.

    FKKG

    STUDY CHAIR

Central Study Contacts

Dominic Dellweg, M.D.

CONTACT

+49 2972 791d.dellweg@fkkg.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2008

Last Updated

August 21, 2006

Record last verified: 2006-02

Locations

DE(1)