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Completed

NCT Number: NCT04120142

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

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bilel TOUNSI

Sousse, 4002, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary rehabilitation+IMT

Other

The experimental group receives inspiratory muscle training and aerobic exercise.

Pulmonary Rehabilitation

Other

The Active Comparator group received only aerobic exercise.

Primary outcomes

  1. Dyspnoea

    Time frame: Baseline, After 2 months

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

  2. Inspiratory muscle strength

    Time frame: Baseline, After 2 months

    The inspiratory muscle strength were measured by maximal inspiratory pressure test

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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