NCT04120142

Brief Summary

Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress. The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

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

Timeline
Completed

Started Feb 2019

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

Geographic Reach
1 country

1 active site

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

February 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

September 30, 2019

Last Update Submit

January 31, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDIMT6MWTDyspoeaSGRQ

Outcome Measures

Primary Outcomes (2)

  • Dyspnoea

    The dyspnoea were measured before and after the 6 minutes walk test

    Baseline, After 2 months

  • Inspiratory muscle strength

    The inspiratory muscle strength were measured by maximal inspiratory pressure test

    Baseline, After 2 months

Study Arms (2)

IMT goup

EXPERIMENTAL

Inspiratory muscle training + aerobic exercice

Other: Pulmonary rehabilitation+IMT

Control group

ACTIVE COMPARATOR

aerobic exercice

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation+IMTOTHER

The experimental group receives inspiratory muscle training and aerobic exercise.

IMT goup
Pulmonary rehabilitationOTHER

The Active Comparator group received only aerobic exercise.

Control group

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Were COPD diagnosed by pulmonary function testing
  • Clinically stable
  • Abscence of other obstructive diseases
  • Signed written consert

You may not qualify if:

  • Were previous pneumonectomy or lobectomy in the past 6 months
  • spontaneous risk of pneumothorax or rib fracture
  • Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
  • The absence of written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilel TOUNSI

Sousse, 4002, Tunisia

Location

Related Publications (3)

  • Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.

    PMID: 25858974BACKGROUND

  • 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: 29371379BACKGROUND

  • Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1):1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. No abstract available.

    PMID: 29371389BACKGROUND

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
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 9, 2019

Study Start

February 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)