CClinicalTrials.gg
Status unknownNCT04271124Updated Feb 17, 2020

COPD and Inflammatory Mediators

An interventional study of exercise training in COPD, sponsored by Faculty of Medicine, Sousse. Status unknown at 1 site in Tunisia. Open to male participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Faculty of Medicine, Sousse · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • COPD
03

In context

Lead sponsor

Faculty of Medicine, Sousse is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Neuromuscular diseases -Severe psychiatric, neurologic or musculoskeletal conditions
  • cardiovascular diseases.
  • Contre-indications to physical therapy
  • Acute exacerbations a month before the intervention
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    PR

    Other: exercise training

  • Experimental
    PR+ET

    Other: exercise training

Interventions

  • Otherexercise training

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

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What researchers measure

Primary outcomes

  1. Change of Interleukins concentrations

    ELISA assay

    Time frame: Before the training, 2 months

Secondary outcomes

  1. 6Minutes Walk test

    patients performed the test

    Time frame: Before the training, 2 months

07

Study locations

1 of 1 sites recruiting
  • Laboratoire de Recherche : Physiologie de l'Exercice et Physiopathologie
    Sousse, 4002, Tunisia
    • Amal Acheche, phd · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04271124
Lead sponsor
Faculty of Medicine, Sousse
Responsible party
Acheche Amal (PhD, Faculty of Medicine, Sousse) — Principal investigator
First posted
Feb 17, 2020
Start date
May 2020 (estimated)
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Feb 17, 2020

Study contacts

Amal Acheche, PhD
Contact
acheche_amal@hotmail.com
00216 55028619
Yassine Trabelsi, professor
Contact
trabelsiyassine@yahoo.fr
00216 20 202 963
Yassine Trabelsi, professor
study director · Laboratoire de recherche:Physiologie de l'Exercice et Physiopathologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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