NCT04271124

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 30, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 17, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 30, 2020

Last Update Submit

February 13, 2020

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Change of Interleukins concentrations

    ELISA assay

    Before the training, 2 months

Secondary Outcomes (1)

  • 6Minutes Walk test

    Before the training, 2 months

Study Arms (2)

PR

ACTIVE COMPARATOR
Other: exercise training

PR+ET

EXPERIMENTAL
Other: exercise training

Interventions

exercise trainingOTHER

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

PRPR+ET

Eligibility Criteria

Age50 Years - 70 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
  • 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)

Laboratoire de Recherche : Physiologie de l'Exercice et Physiopathologie

Sousse, 4002, Tunisia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yassine Trabelsi, professor

    Laboratoire de recherche:Physiologie de l'Exercice et Physiopathologie

    STUDY DIRECTOR

Central Study Contacts

Amal Acheche, PhD

CONTACT

00216 55028619acheche_amal@hotmail.com

Yassine Trabelsi, professor

CONTACT

00216 20 202 963trabelsiyassine@yahoo.fr

Study Design

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

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 17, 2020

Study Start

May 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 17, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)