COPD and Inflammatory Mediators

NCT ID: NCT04271124

Last Updated: 2020-02-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2020-07-31

Brief Summary

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Chronic obstructive pulmonary disease (COPD) is widely spread all over the world. It is predicted to be the third leading cause of death by 2020.

Detailed Description

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COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversible.Not only the long-term exposition to noxious particles and gases contributes to the development of COPD, but also many others factors such as genetics and cigarette smoking. Cigarettes are harmful and contribute to different extra pulmonary disorders. Although COPD affects lungs some extrapulmonary manifestations are prescribed such as muscle dysfunction, abnormal respiratory muscles and systemic inflammation. Indeed, the systemic inflammation\[6, 8\] is considered as a key process in the pathogenesis of COPD. It involves different cells and molecules; high levels of circulating of white blood cells, increased plasma c-reactive proteins (CRP), interleukin 6 (Il6) have been reported in.those patients.Likewise, systemic inflammation could worsen the comorbidities (cardiovascular, osteoporosis..) and may lead to the exercise limitation.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PR

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type OTHER

The patients are allocated to PR+ET group or PR Each group receive an exercise training

PR+ET

Group Type EXPERIMENTAL

exercise training

Intervention Type OTHER

The patients are allocated to PR+ET group or PR Each group receive an exercise training

Interventions

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exercise training

The patients are allocated to PR+ET group or PR Each group receive an exercise training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Neuromuscular diseases -Severe psychiatric, neurologic or musculoskeletal conditions
* cardiovascular diseases.
* Contre-indications to physical therapy
* Acute exacerbations a month before the intervention
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 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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Acheche Amal

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yassine Trabelsi, professor

Role: STUDY_DIRECTOR

Laboratoire de recherche:Physiologie de l'Exercice et Physiopathologie

Locations

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Laboratoire de Recherche : Physiologie de l'Exercice et Physiopathologie

Sousse, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Amal Acheche, PhD

Role: CONTACT

00216 55028619

Yassine Trabelsi, professor

Role: CONTACT

00216 20 202 963

Other Identifiers

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Effect of exercise training

Identifier Type: -

Identifier Source: org_study_id

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