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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120142
Other study ID # COPD-DYS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date December 1, 2019

Study information

Verified date January 2020
Source Faculty of Medicine, Sousse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation+IMT
The experimental group receives inspiratory muscle training and aerobic exercise.
Pulmonary rehabilitation
The Active Comparator group received only aerobic exercise.

Locations

Country Name City State
Tunisia Bilel TOUNSI Sousse

Sponsors (1)

Lead Sponsor Collaborator
Faculty of Medicine, Sousse

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1). pii: 1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. — View Citation

Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran 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). pii: 1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan. — View Citation

Langer D, Charususin N, Jácome 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dyspnoea The dyspnoea were measured before and after the 6 minutes walk test Baseline, After 2 months
Primary Inspiratory muscle strength The inspiratory muscle strength were measured by maximal inspiratory pressure test Baseline, After 2 months
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