NCT03853174

Brief 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\[2\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

February 21, 2019

Last Update Submit

December 18, 2019

Conditions

Keywords

COPDInflammationexercise training

Outcome Measures

Primary Outcomes (1)

  • Enzyme linked immunosorbent assay for serum cytokines levels change

    The interleukines were determined by ELISA assays with commercial kits

    Baseline, 6 months

Study Arms (2)

ET

ACTIVE COMPARATOR

Active Comparator: ET Endurance training were prformed. Intensity was gradually increased.

Other: Endurance Training ET

RT

OTHER

Resistance training were prformed. Intensity was gradually increased.

Other: Resistance Training RT

Interventions

Endurance training were prformed. Intensity was gradually increased.

ET

Resistance training were prformed. Intensity was gradually increased.

RT

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amal Acheche

Sousse, 4002, Tunisia

Location

Related Publications (4)

  • authors non mentionned., global initiative for chronic lung disease. 2017

    BACKGROUND
  • 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.

    PMID: 16798034BACKGROUND
  • 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.

    PMID: 27373322BACKGROUND
  • 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.

    PMID: 24507838BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInflammation

Interventions

Endurance TrainingResistance Training

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amal Acheche, Phd

    Faculty of Medicine of Sousse Sousse, Tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 25, 2019

Study Start

January 1, 2019

Primary Completion

April 17, 2019

Study Completion

April 27, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations