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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120142
• Other study ID #: COPD-DYS
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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