Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients

NCT ID: NCT04120142

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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IMT goup

Inspiratory muscle training + aerobic exercice

Group Type EXPERIMENTAL

Pulmonary rehabilitation+IMT

Intervention Type OTHER

The experimental group receives inspiratory muscle training and aerobic exercise.

Control group

aerobic exercice

Group Type ACTIVE_COMPARATOR

Pulmonary rehabilitation

Intervention Type OTHER

The Active Comparator group received only aerobic exercise.

Interventions

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Pulmonary rehabilitation+IMT

The experimental group receives inspiratory muscle training and aerobic exercise.

Intervention Type OTHER

Pulmonary rehabilitation

The Active Comparator group received only aerobic exercise.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Medicine, Sousse

OTHER

Sponsor Role lead

Responsible Party

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Bilel Tounsi

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bilel TOUNSI

Sousse, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type BACKGROUND
PMID: 25858974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29371379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29371389 (View on PubMed)

Other Identifiers

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COPD-DYS

Identifier Type: -

Identifier Source: org_study_id

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