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.: PACTR201711002735285 Date of Approval: 30/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title the impact of pulmonary rehabilitation in patients with COPD
Official scientific title The effect of adding neuromuscular electrical stimulation training to pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomised clinical trial.
Brief summary describing the background and objectives of the trial Falls are associated with increased mortality, decreased independence and physical activity levels, and worsening quality of life in patients with chronic obstructive pulmonary disease. In pulmonary rehabilitation, exercise protocol focuses primarily on endurance training leading to clinically significant improvement in sub-maximal exercise performance with variable effects on maximal exercise capacity. Recently, the neuromuscular electrical stimulation of the lower limbs has been successfully utilized as a useful alternative training method to increase quadriceps femoris strength, improve walking tolerance in patients with COPD. The effects of neuromuscular electrical stimulation applying on lower-limb muscles on balance have been only analyzed in chronic obstructive pulmonary disease -free older patients. These effects were turned out to be efficient but they deserve to be confirmed in patients with chronic obstructive pulmonary disease in order to optimize the pulmonary rehabilitation programs
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 04/09/2017
Actual trial start date
Anticipated date of last follow up 05/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 45
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 who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group neuromuscular electrical stimulation group 3 times per week 45-80 min endurance training and neuromuscular electrical stimulation 25
Control Group pulmonary rehabilitation group 3 times per week 45-80 min pulmonary rehabilitation 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Stable COPD patients (2) absence of other obstructive disease (asthma, bronchiectasis...) and (3) lack of musculoskeletal or neurologic conditions that might affect their exercise performance 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. 60 Year(s) 79 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 six minutes walking test, balance assesssment, maximal voluntary contraction. for all outcomes measures: before and after training program
Secondary Outcome spirometry and anthropometric measures for all outcomes measures: before and after training program
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. Yassine trabelsi 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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information