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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201711002731292
Date of registration: 30/10/2017
Prospective Registration: No
Primary sponsor: mekki marwa
Public title: Impact of pulmonary rehabilitation programme for COPD patients
Scientific title: Effect of Neuromuscular Electrical Stimulation Training added to Pulmonary Rehabilitation on psychosocial outcomes
Date of first enrolment: 05/06/2017
Target sample size: 50
Recruitment status: Pending
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2731
Study type:  Interventional
Study design:  Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Allocation was determined by the holder of the sequence who is situated off site  
Phase:  Not Applicable
Countries of recruitment
Tunisia
Contacts
Name: Yassine    Trabelsi
Address:  Avenue Mohamed Karoui, 4002, Sousse, Tunisia 4002 sousse Tunisia
Telephone: +21620202963
Email: trabelsiyassine@yahoo.fr
Affiliation:  Department of Physiology and Lung Function Testing University of Sousse
Name: Marwa     Mekki
Address:  Avenue Mohamed Karoui, 4002, Sousse, Tunisia 4002 sousse Tunisia
Telephone: +21652918384
Email: Mekkimarwa52@yahoo.fr
Affiliation:  Department of Physiology and Lung Function Testing University of Sousse
Key inclusion & exclusion criteria
Inclusion criteria: (1) stable COPD patients, absence of other obstructive disease (asthma, bronchiectasis...) and (3) lack of musculoskeletal or neurologic conditions that might affect their exercise performance, symptomatic cardiac disease, or previous lung surgery
Exclusion criteria: Individuals who smoke and those who run significant response to bronchodilators, defined as an increase in forced expiratory volume in 1 second over 12% from predicted values were excluded from our study.

Age minimum: 65 Year(s)
Age maximum: 76 Year(s)
Gender: Male
Health Condition(s) or Problem(s) studied

Respiratory
chronic obstructive pulmonary disease
Respiratory
chronic obstructive pulmonary disease
Intervention(s)
neuromuscular electro stimulation added to pulmoanary rehabilitation
PR group
Primary Outcome(s)
6-Minutes Walking Test (6MWT) and psychosocial tests
Secondary Outcome(s)
spirometry
Secondary ID(s)
Source(s) of Monetary Support
Department of Physiology and Lung Function Testing (UR12 ES06), Faculty of Medicine of Sousse, University of Sousse, Tunisia
Secondary Sponsor(s)
Prof. Yassine trabelsi
Ethics review
Status: Approved
Approval date: 03/04/2017
Contact:
the Research Ethics Committee of Farhat Hached Hospital (Sousse)
Results
Results available:
Date Posted:
Date Completed:
URL:
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