NCT02074813

Brief Summary

Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2014

Typical duration 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

First Submitted

Initial submission to the registry

February 27, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

February 27, 2014

Last Update Submit

October 24, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Inspiratory muscle trainingCOPDdyspneaMultidimensional Dyspnea Profile questionnaire (MDP).pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Dyspnea measure

    Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.

    21 - 4 days / +7 jours

Secondary Outcomes (3)

  • PI max variation

    21 - 4 days / +7 days

  • CI variation

    21 - 4 days / +7 days

  • Dyspnea measure

    21 - 4 days / +7 days

Study Arms (2)

Standard

NO INTERVENTION

conventional pulmonary rehabilitation

Inspiratory muscle training

EXPERIMENTAL

Inspiratory muscle training associated with a conventional pulmonary rehabilitation

Other: Inspiratory muscle training

Interventions

Inspiratory muscle trainingOTHER

Inspiratory muscle training

Inspiratory muscle training

Eligibility Criteria

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

You may qualify if:

  • Patients with COPD stage 3 or 4
  • Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;

You may not qualify if:

  • FEV ≥ 50%
  • Pneumonectomy, Lobectomy less than 6 months
  • Patient with risk of spontaneous pneumothorax or rib fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre des maladies respiratoires et allergiques - Les Acacias

Briançon, France, 05107, France

Location

Brest University Hospital

Morlaix, France, 29672, France

Location

Related Publications (2)

  • Beaumont M, Couasnon C, Peran L, Berriet AC, Ber CL, Pichon R. Determination of the minimal important difference for inspiratory muscle strength in people with severe and very severe COPD. Clin Rehabil. 2023 Nov;37(11):1521-1532. doi: 10.1177/02692155231174124. Epub 2023 May 15.

    PMID: 37186772DERIVED

  • Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

    PMID: 29371379DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns 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 27, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

FR(2)