COPD and Inflammatory Mediators

February 13, 2020 updated by: Acheche Amal, Faculty of Medicine, Sousse

Comparison of Exercise Training

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4002
        • Recruiting
        • Laboratoire de Recherche : Physiologie de l'Exercice et Physiopathologie
        • Principal Investigator:
          • Amal Acheche, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PR
Other: exercise training
The patients are allocated to PR+ET group or PR Each group receive an exercise training
EXPERIMENTAL: PR+ET
Other: exercise training
The patients are allocated to PR+ET group or PR Each group receive an exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Interleukins concentrations
Time Frame: Before the training, 2 months
ELISA assay
Before the training, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6Minutes Walk test
Time Frame: Before the training, 2 months
patients performed the test
Before the training, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Investigators

  • Study Director: Yassine Trabelsi, professor, Laboratoire de recherche:Physiologie de l'Exercice et Physiopathologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Effect of exercise training

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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