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.: PACTR202303849880222 Date of Approval: 31/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of rehabilitation on patients with post covid-19
Official scientific title Effect of a pulmonary rehabilitation program on lung function and submaximal exercise capacity of Tunisian patients with post-COVID19: A randomized clinical trial
Brief summary describing the background and objectives of the trial the pandemic of coronavirus disease 2019 involves the respiratory system and several extra pulmonary organs. Even under appropriate mediacl treatment it can cause permanent sytructural damage and be responsible of symptoms that last > 12 weeks (e.g. dyspnea, cough, fatigue, pain, rest tachycardia...), this is called "long COVID-19" and this can affect the quality of life. therefore cardiorespiratory rehabilitation is hyghly recommanded. The main aim of this study is to evaluate the impact of a cardiorespiratory rehabilitation on submaximal exercise capacity and social disadvantage data in post-COVID19 Tunisian patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/03/2023
Actual trial start date 27/03/2023
Anticipated date of last follow up 08/05/2023
Actual Last follow-up date 08/05/2023
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Respiratory rehabilitaion program Three times a week 6 weeks The program will include 18 sessions of exercise-training (aerobic cycle endurance and strength training session). 30
Control Group No respiratory rehabilitaion program None 6 weeks Nothing 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with confirmed covid 19 by PCR test Persistant dyspnea 3 months after resolution of covid 19 Patients having stage II mMRC dyspnea or more Respiratory chronic pathology Cardiology disease Patients with osteoarthritis Active smoking Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 77 Year(s) Both
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 03/03/2023 Ethics committe of the faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Spirometric data and social disadvantage data One week before the intervention and one week after the intervention
Primary Outcome 6-min walk distance. One week before the intervention and one week after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pulmonology department in Fattouma BOURGUIBA University hospital Avenue Farhat HACHED Monastir 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
rania kaddoussi farhat hached street monastir Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Helmi BEN SAAD Faculty of Medicine of sousse Sousse 4000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Helmi BEN SAAD Mohamed KAROUI Sousse 4000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hadhemi REJEB hadhemi.rejeb@gmail.com 0021652227856 IBN NAFISS pulmonology department abderrahmane mami ariana hospital
City Postal code Country Position/Affiliation
Ariana 2080 Tunisia University assistant
Role Name Email Phone Street address
Scientific Enquiries Rania KADDOUSSI kaddoussi.rania@gmail.com 0021626937703 pulmonary department fattouma bourguiba hospital
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia University assistant
Role Name Email Phone Street address
Public Enquiries Amine KALAI amine.kalai.1@gmail.com 00021652227856 Physical medicine department
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia University assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data will be available: individual participant data that underline the results reported in this article (texte, table, figures and appendices), ethics approval Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediatly following publication Ending 5 years following article publication Anyyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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