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.: PACTR201704002174545 Date of Approval: 04/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title rehabilitation in COPD patients
Official scientific title Comparative analysis of effects on endurance training programs combined with voluntary or stimulated contractions in patients with COPD
Brief summary describing the background and objectives of the trial Patients with chronic obstructive pulmonary disease (COPD) are markedly inactive in daily life.Physical activity is one of the most common interventions to avoid postural balance impairment (eg, risk of fall and falls). Exercise training is the corner stone of pulmonary rehabilitation. Several training programs have been recommended in patients with COPD. Strength training (ST) of lower and upper limb, focusing on weight lifting and endurance training (ET)that include whole body exercise such as cycling has been well investigated and well tolerated in these patients. in addition, Neuromuscular electrical stimulation (NMES) and voluntary contraction (VOL) are different modes of muscle activation that induce physiological effects on the neuromuscular system. However, it has been shown that combined training (ST combined with ET) seems to have achieved a more complete physiologically significant 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 COPD. This is why we aimed to analyse and compare the effects of combined ET and ST programs (VOL or NMES) on respiratory function, exercise tolerance and postural balance in COPD patients.
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 Education /Training
Anticipated trial start date 17/02/2015
Actual trial start date 23/02/2015
Anticipated date of last follow up 17/08/2015
Actual Last follow-up date 24/08/2015
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 41
Recruitment status Completed
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 randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ET+VOL 85 minutes per session / 3 sessions weekly 6 months endurance training + voluntary contraction 21
Experimental Group ET+NMES 85 minutes per session / 3 sessions weekly 6 months Endurance training+ neuromuscular electrical stimulation 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with stable clinical and functional diagnosis of COPD according to the global strategy for the diagnosis, management and prevention of COPD guideline were selected Smokers and those who suffer from cardiovascular or neurological disease, lower extremity musculoskeletal problems and visual deficits were excluded from the study. 55 Year(s) 66 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 05/01/2013 ethics committee and medical recherche of Hospital Farhat Hached
Ethics Committee Address
Street address City Postal code Country
avenue Ibn El Jazzar SOUSSE 4000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Timed Up and Go test (TUG) , the Berg Balance Scale (BBS) and the centre of pressure (CoP) excursions was recorded using a static stabilometric platform (PostureWin© Techno Concept, France; 40 Hz frequency). 6-Minutes Walking Test (6MWT)The test was performed indoors, along a 40m-flat and straight, walking course with chairs placed along the corridor in case patients needed to rest.
Secondary Outcome Spirometry and anthropometric measures - Body weight (BW) was measured with a digital scale (Harpenden balance scale, Holtain Ltd, Crosswell, UK) and height was measured with an appropriate stadiometer (Harpenden portable stadiometer, Holtain Ltd, Crosswell, UK).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Physiology and Lung Function Testing (UR12ES06), 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 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 University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Science of Bizerte, University of Carthage, Tunisia. aculté des Sciences de Bizerte 7021 Jarzouna- TUNISIE Bizerte 7021 Tunisia
Research Unit Education, Motricity, Sports and Health,(UR15JS01) High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia oute de l'Aéroport, Km 3,5, BP 384, Sfax 3000, Tunisie SFAX 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Mekki Mekkimarwa52@yahoo.fr +21652918384 Street Ali Belhwean chebba, Mahdia .
City Postal code Country Position/Affiliation
Chebba, mahdia 5170 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 Street Ali Belhwean chebba, Mahdia
City Postal code Country Position/Affiliation
Chebba, mahdia 5170 Tunisia Department of Physiology and Lung Function Testing University of Sousse
REPORTING
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