- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853174
Exercise Training and Inflammatory Mediators in COPD
December 18, 2019 updated by: Acheche Amal, Faculty of Medicine, Sousse
Effect of Exercise Training on Inflammatory Mediators in COPD
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[1].
COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversable[2].
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversable.Not only the long-term exposition to noxious particles and gases contributes to the development of COPD, but also so many others factors such as genetics and cigarette smoking.
It has been shown that cigarettes are harmful and contributed to different extra pulmonary disorders.
Indeed, it induced a systemic inflammation that was considered as a key process in the pathogenesis of COPD and triggered the activation of inflammatory cells and an abnormal increase of circulating cytokines such as CRP, interleukin (IL6), IL8, tumor necrosis factor alpha (TNF alpha) and leptin.
Study Type
Interventional
Enrollment (Actual)
28
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 Locations
-
-
-
Sousse, Tunisia, 4002
- Amal Acheche
-
-
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
40 years to 75 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 and /or instable--- --
- 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ET
Active Comparator: ET Endurance training were prformed.
Intensity was gradually increased.
|
Endurance training were prformed.
Intensity was gradually increased.
|
Other: RT
Resistance training were prformed.
Intensity was gradually increased.
|
Resistance training were prformed.
Intensity was gradually increased.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enzyme linked immunosorbent assay for serum cytokines levels change
Time Frame: Baseline, 6 months
|
The interleukines were determined by ELISA assays with commercial kits
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amal Acheche, Phd, Faculty of Medicine of Sousse Sousse, Tunisia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barnes PJ. Inflammatory mechanisms in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2016 Jul;138(1):16-27. doi: 10.1016/j.jaci.2016.05.011. Epub 2016 May 27.
- authors non mentionned., global initiative for chronic lung disease. 2017
- Molfino NA, Jeffery PK. Chronic obstructive pulmonary disease: histopathology, inflammation and potential therapies. Pulm Pharmacol Ther. 2007;20(5):462-72. doi: 10.1016/j.pupt.2006.04.003. Epub 2006 May 6.
- Barnes PJ. Cellular and molecular mechanisms of chronic obstructive pulmonary disease. Clin Chest Med. 2014 Mar;35(1):71-86. doi: 10.1016/j.ccm.2013.10.004. Epub 2013 Dec 12.
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 (Actual)
January 1, 2019
Primary Completion (Actual)
April 17, 2019
Study Completion (Actual)
April 27, 2019
Study Registration Dates
First Submitted
February 21, 2019
First Submitted That Met QC Criteria
February 22, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
December 20, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- COPD and exercise
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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