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.: PACTR201706002340256 Date of Registration: 06/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neuromuscular Electrical Stimulation Training on balance in COPD patients
Official scientific title Effect of Neuromuscular Electrical Stimulation Training with Pulmonary Rehabilitation on Balance in Patients with COPD.
Brief summary describing the background and objectives of the trial Patients with COPD fall frequently, although the risk of falls may seem less important than the respiratory consequences of the disease. Falls are associated with increased mortality, decreased independence and physical activity levels, and worsening quality of life.In PR, 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, several investigations have reported the benefit of balance training for patients with COPD .Neuromuscular electrical stimulation (NMES) of the lower limbs has been successfully utilized as a useful alternative training method in patients with COPD . Increases in quadriceps femoris strength improve exercise tolerance and quality of life after NMES . Knowing that loss of muscle strength is one of the major factors affecting balance and the COPD disease reduces physical activity and subsequently functional capacity , it seems then important to investigate NMES effects on balance and exercise tolerance of patients with COPD to help design new rehabilitation therapies. Therefore, the aim of this study was to analyze the effects of NMES combined in PR on exercise tolerance and 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 10/11/2014
Actual trial start date 12/01/2015
Anticipated date of last follow up 11/05/2015
Actual Last follow-up date 15/06/2015
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants) 45
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 radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PR+NMES group 85 min per session/ 3 per weeks 6 months pulmonary rehabilitation + neuromuscular electro stimulation 25
Control Group PR group 85 minutes per session / 3 sessions weekly 6 months pulmonary rehabilitation only 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) a diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and post-bronchodilator results on spirometry of forced expiratory volume in 1 second (FEV1) / Forced vital capacity (FVC) < 0.7 according to GOLD guidelines (2) 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 Individuals who smoke and those who run significant response to bronchodilators, defined as an increase in FEV1 over 12% from predicted values were excluded from our study. 56 Year(s) 69 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 24/01/2014 Resarch ethics comittee of farhat hached hospital (sousse)
Ethics Committee Address
Street address City Postal code Country
street Ibn Jazzar SOUSSE 4031 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Exercise tolerance, balance, Time Up and Go (TUG) test, Berg Balance Scale (BBS) and the maximal voluntary contraction (MVC) of the quadriceps muscle were recorded. A 6 Minute Walk Test (6MWT) was conducted to determine the exercise tolerance according to the international recommendations testing using a 40 m hospital corridor with chairs placed along the corridor in case patients needed to rest. Dyspea was measured using the Borg scale before and at the end of the test
Secondary Outcome Pulmonary function testing All subjects underwent pulmonary function testing with determination of forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) measurement was performed using a constant volume plethysmograph (ZAN 500 Body II, ZAN Me¿grerate GmbH, Germany)according to the European Respiratory recommendations
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 rue ali belhwen chebba mahdia tunis, rue ali belhwen chebba mahdia tunis La Chebba 5170 Tunisia University
Secondary Sponsor Yassine trabelsi Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Sonia Sahli High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia SFAX 3023 Tunisia
Thierry Paillard University of Pau and des Pays de l¿Adour, France pau 64012 Pau, France France
Yassine trabelsi Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia
zouhair tabka Avenue Mohamed Karoui, 4002, Sousse, Tunisia SOUSSE 4002 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Mekki Mekkimarwa52@yahoo.fr +21652918384 Street ali belhween
City Postal code Country Position/Affiliation
Chebba mahdia 5170 Tunisia Department of Physiology and Lung Function Testing, Faculty of Medicine, University of Sousse
Role Name Email Phone Street address
Public Enquiries Yassine trabelssi Trabelsiyassine882@gmail.com +21624918382 Avenue Mohamed Karoui,
City Postal code Country Position/Affiliation
sousse 4200 Tunisia Department of Physiology and Lung Function Testing, Faculty of Medicine, University of Sousse
Role Name Email Phone Street address
Scientific Enquiries Marwa Mekki Mekkimarwa52@yahoo.fr +21652918384 Street ali belhween
City Postal code Country Position/Affiliation
Chebba mahdia 5170 Tunisia Department of Physiology and Lung Function Testing, Faculty of Medicine, University of Sousse
REPORTING
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