NCT01545011

Brief Summary

The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP \> 60 cmH2O).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 3, 2025

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

February 29, 2012

Last Update Submit

November 26, 2025

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Inspiratory muscle trainingCOPDConventional respiratory rehabilitationDyspnea scale

Outcome Measures

Primary Outcomes (1)

  • Dyspnea measure

    Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire

    21 days

Study Arms (2)

standard

NO INTERVENTION

conventional respiratory rehabilitation

IMT

EXPERIMENTAL

Inspiratory muscle training and conventional respiratory rehabilitation

Other: Inspiratory muscle training

Interventions

Inspiratory muscle trainingOTHER

Inspiratory muscle training

IMT

Eligibility Criteria

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

You may qualify if:

  • Patient with COPD
  • Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course

You may not qualify if:

  • Pneumonectomy, Lobectomy less than 6 months
  • Cardio-pulmonary anomaly
  • Max inspiratory pressure \< 60 cm H2O

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brest University Hospital

Brest, Brittany Region, 29200, France

Location

Hospital of Morlaix

Morlaix, Brittany Region, 29600, France

Location

Related Publications (1)

  • Beaumont M, Mialon P, Le Ber-Moy C, Lochon C, Peran L, Pichon R, Gut-Gobert C, Leroyer C, Morelot-Panzini C, Couturaud F. Inspiratory muscle training during pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomized trial. Chron Respir Dis. 2015 Nov;12(4):305-12. doi: 10.1177/1479972315594625. Epub 2015 Jul 13.

    PMID: 26170421RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 6, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

September 1, 2012

Last Updated

December 3, 2025

Record last verified: 2012-09

Locations

FR(2)