Main
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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:
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PACTR |
Last refreshed on:
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29 May 2023 |
Main ID: |
PACTR201711002731292 |
Date of registration:
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30/10/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact of pulmonary rehabilitation programme for COPD patients
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Scientific title:
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Effect of Neuromuscular Electrical Stimulation Training added to Pulmonary Rehabilitation on psychosocial outcomes |
Date of first enrolment:
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05/06/2017 |
Target sample size:
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50 |
Recruitment status: |
Pending |
URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2731 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Not Applicable
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Yassine
Trabelsi |
Address:
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Avenue Mohamed Karoui, 4002, Sousse, Tunisia
4002
sousse
Tunisia |
Telephone:
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+21620202963 |
Email:
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trabelsiyassine@yahoo.fr |
Affiliation:
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Department of Physiology and Lung Function Testing University of Sousse |
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Name:
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Marwa
Mekki |
Address:
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Avenue Mohamed Karoui, 4002, Sousse, Tunisia
4002
sousse
Tunisia |
Telephone:
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+21652918384 |
Email:
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Mekkimarwa52@yahoo.fr |
Affiliation:
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Department of Physiology and Lung Function Testing University of Sousse |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Respiratory chronic obstructive pulmonary disease
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Respiratory
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chronic obstructive pulmonary disease
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Intervention(s)
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neuromuscular electro stimulation added to pulmoanary rehabilitation
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PR group
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Primary Outcome(s)
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6-Minutes Walking Test (6MWT) and psychosocial tests
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Secondary Outcome(s)
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spirometry
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Source(s) of Monetary Support
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Department of Physiology and Lung Function Testing (UR12 ES06), Faculty of Medicine of Sousse, University of Sousse, Tunisia
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Ethics review
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Status: Approved
Approval date: 03/04/2017
Contact:
the Research Ethics Committee of Farhat Hached Hospital (Sousse)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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