COPDNCT03853174
Exercise Training and Inflammatory Mediators in COPD
A study testing Endurance Training ET and Resistance Training RT in people with COPD, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial 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[1]. COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversable[2]. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- COPD
- What is being tested?
- Endurance Training ET and Resistance Training RT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2019to 27 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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].
Read the 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.
- Conditions
- COPD
- Being tested
- Endurance Training ET, Resistance Training RT
- Keywords
- COPD, Inflammation, exercise training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance Training ETOther
Endurance training were prformed. Intensity was gradually increased.
Resistance Training RTOther
Resistance training were prformed. Intensity was gradually increased.
| Study group | Role | What they receive |
|---|---|---|
| ET | Active comparator | Active Comparator: ET Endurance training were prformed. Intensity was gradually increased. Receives: Other: Endurance Training ET |
| RT | Other | Resistance training were prformed. Intensity was gradually increased. Receives: Other: Resistance Training RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enzyme linked immunosorbent assay for serum cytokines levels change
The interleukines were determined by ELISA assays with commercial kits
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jan 2019
- Primary completion17 Apr 2019
- Study completion27 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acheche Amal, Faculty of Medicine, Sousse
- Investigators
- Amal Acheche, Phd, Principal investigator, Faculty of Medicine of Sousse Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853174
- Sponsor's protocol ID
- COPD and exercise
- Status last verified
- Dec 2019
- First submitted
- 21 Feb 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16798034Barnes 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.
PubMed 27373322Barnes 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.
PubMed 24507838
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Inflammatory Mediators in COPD
- ClinicalTrials.gov ID
- NCT03853174
- Acronym / sponsor ID
- COPD and exercise
- Conditions
- COPD
- Keywords
- COPD, Inflammation, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 27 Apr 2019 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET | Active comparator | Other: Endurance Training ETActive Comparator: ET Endurance training were prformed. Intensity was gradually increased. |
| RT | Other | Other: Resistance Training RTResistance training were prformed. Intensity was gradually increased. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance Training ETEndurance training were prformed. Intensity was gradually increased. | Other | ET |
| Resistance Training RTResistance training were prformed. Intensity was gradually increased. | Other | RT |
Primary outcome
Enzyme linked immunosorbent assay for serum cytokines levels change
Time frame: Baseline, 6 months
The interleukines were determined by ELISA assays with commercial kits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Backgroundauthors non mentionned., global initiative for chronic lung disease. 2017
- Background: PubMed 16798034Molfino 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.
- Background: PubMed 27373322Barnes 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.
- Background: PubMed 24507838Barnes 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.
- Individual participant dataSharing planned: No
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Acheche, Phd principal investigator
Faculty of Medicine of Sousse Sousse, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Training ET and Resistance Training RT in people with COPD, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enzyme linked immunosorbent assay for serum cytokines levels change (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853174, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.