Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002730365 Date of Approval: 30/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of pulmonary rehabilitation programme for chronic obstructive pulmonary disease (COPD) patients
Official scientific title evaluation of the combined effect of endurance training or strength training on endurance tolerance and muscle strength of the lower limbs.
Brief summary describing the background and objectives of the trial Numerous studies have shown that endurance training (ET) and strength training (ST) programs, based on voluntary contraction (VOL) or neuromuscular electrical stimulation (NMES) improves physical capacities and muscle strength. However, it has been shown that combined training (ST combined with ET) seems to have achieved a better improvement in strength compared to ST or ET alone. None of these studies has analyzed the effects of combined ET and ST programs based on voluntary or stimulated contractions (VOL or NMES) on exercise tolerance and muscle strength of the lower limbs
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied chronic obstructive pulmonary disease ,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 11/09/2017
Actual trial start date 06/11/2017
Anticipated date of last follow up 05/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ET added to voluntary contraction 3 times per week, for 24 weeks 45-80 min endurance training added to voluntary contraction 33
Experimental Group ET added to neuromuscular electrical stimulation 3 times per week, for 24 weeks 45-80 min Endurance training combined with neuromuscular electrical stimulation 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Stable COPD patients, absence of other obstructive disease (eg, asthma, bronchiectasis); (3) lack of recent cardiac or neuromuscular pathologies; and (4) a fall in the last 5 years or a recent near-fall. Individuals who smoked and those who had a significant response to bronchodilators, defined as an increase > 12% in forced expiratory volume in 1 second . cognitive deficiency, a neurological or locomotive condition that may impair their mobility and balance were excluded from the study 60 Year(s) 71 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/04/2017 the Research Ethics Committee of Farhat Hached Hospital (Sousse)
Ethics Committee Address
Street address City Postal code Country
avenue Ibn El Jazzar SOUSSE 4031 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 6-Minutes Walking Test (6MWT), maximal voluntary contraction (MVC), electromyography (EMG) Exercise tolerance was assessed by 6MWT as described by the International Recommendations. Patients were required to sit with a 90° hip flexion, and a 90° knee flexion. Stabilization straps were positioned across chest and the arms were crossed the chest.
Secondary Outcome spirometry All participants underwent a pulmonary function test using a Spirometry Zan 100 (Inspire Health GmbH, Germany) according to Respiratory Society recommendations, with data related to Tunisian norms
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Physiology and Lung Function Testing (UR12 ES06), Faculty of Medicine of Sousse, University of Sousse, Tunisia Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Physiology and Lung Function Testing (UR12 ES06), Faculty of Medicine of Sousse, University of Sousse, Tunisia Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mekki marwa Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia University
Secondary Sponsor Prof. Zouhair tabka Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
N/A
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Mekki Mekkimarwa52@yahoo.fr +21652918384 Avenue Mohamed Karoui, 4002, Sousse, Tunisia
City Postal code Country Position/Affiliation
sousse 4002 Tunisia Department of Physiology and Lung Function Testing University of Sousse
Role Name Email Phone Street address
Public Enquiries Yassine Trabelsi trabelsiyassine@yahoo.fr +21620202963 Avenue Mohamed Karoui, 4002, Sousse, Tunisia
City Postal code Country Position/Affiliation
sousse 4002 Tunisia Department of Physiology and Lung Function Testing University of Sousse
Role Name Email Phone Street address
Scientific Enquiries Marwa Mekki Mekkimarwa52@yahoo.fr +21652918384 Avenue Mohamed Karoui, 4002, Sousse, Tunisia
City Postal code Country Position/Affiliation
sousse 4002 Tunisia Department of Physiology and Lung Function Testing University of Sousse
REPORTING
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Changes to trial information