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Clinical Trials/NCT04120142
NCT04120142CompletedNot Applicable

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

Faculty of Medicine, Sousse2 sites in 1 country34 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
2
Primary Endpoint
Inspiratory muscle strength

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Inspiratory muscle strength

Time Frame: Baseline, After 2 months

The inspiratory muscle strength were measured by maximal inspiratory pressure test

Dyspnoea

Time Frame: Baseline, After 2 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Faculty of Medicine, Sousse
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bilel Tounsi

PhD

Faculty of Medicine, Sousse

Study Sites (2)

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