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.: PACTR201711002736822 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 combined effects of endurance training and endurance training in patients with COPD
Official scientific title Efficacy of endurance training combined with voluntary or stimulated contractions
Brief summary describing the background and objectives of the trial Inactivity engenders skeletal muscle weakness, body weight loss, systemic inflammation and psychological impairment. The skeletal muscle¿s weakness affects physical and functional capacity and degrades postural balance leading to an increase in labored breathing and falls in patients with COPD. 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 postural balance in patient with chronic obstructive pulmonary disease (COPD).
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 30/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
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 imple randomisation using a radomisation table created by a computer software program llocation 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 Endurance training combined with strength training 3 times per week, for 6 months 45-80 min cycling folled by strength training 25
Experimental Group Endurance training combined with electrical stimulation 3 times per week, for 24 weeks 45-80 min cycling folled by electrical stimulation for both legs 20
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 (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 patients presented with a cognitive deficiency, a neurological or locomotive condition that may impair their mobility and balance were excluded from the study. 68 Year(s) 77 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 08/05/2017 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 exercice tolerance test, balance assessment, quadriceps strength tese above outcomes were measured before and after training programs for both groups
Secondary Outcome spirometry and anthropometric measures these outcomes were measured before and after training programs for both groups
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 Marwa mekki 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information