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.: PACTR202005764510617 Date of Approval: 19/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short-term outcome of a home-based rehabilitation program in COPD tunisian patients
Official scientific title Short-term outcome of a home-based rehabilitation program in COPD tunisian patients
Brief summary describing the background and objectives of the trial background: The objective of this study is to demonstrate feasibility of a home-based simplified rehabilitation program for COPD patients and their adherence to it. We aimed also to analyse its impact on respiratory functional parameters and quality of life after a four months period.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) shest COPD
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 15/01/2019
Actual trial start date 01/02/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 73
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group respiratory rehabilitation at home one session lasts 50 minutes , includes stretching, aerobic exercices, endurance exercices and one strengthening exercice patients perform 2 to 4 sessions a week 4 months a rehabilitation session includes stretching, aerobic exercices, endurance exercices and one strengthening exercice. thin patients should stick to a hyperprotidic diet, give up smoking 30
Control Group non adherence to respiratory rehabilitation none 4 months this group includes patients who did not perform respiratory rehabilitation recommended by the researcher 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
COPD confirmed by a spirometry with a B2agonists reversibility test Patients put on an inhaled treatment during at least a year records and follow up in Abderrahmen Mami Hospital Written informed consent presence of other respiratory or chest disease which influence the respiratory functional testings chronic respiratory failure which hamper performing a spirometry or a physical exercise exacerbated patient with no possibility to assess his respiratory state percutaneous oxymetry under 90% at rest, before any functional testing instable chronic disease or musculoskeletal impairement which may influence the respiratory functional testings contra-indication of a 6 minutes walk test non investigated thoracic pain or intermittent claudication withdrawal of consent 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 08/10/2018 Abderrahmen Mami Ethics commitee
Ethics Committee Address
Street address City Postal code Country
2 rue de lhopital Ariana 2080 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess the enhancement of the functional respiratory tests, essentially FEV1 and 6 minutes walk test, after 4 months of respiratory rehabilitation at home, in COPD patients. assess the impact of respiratory rehabilitation at home on the disease symptoms, dyspnea mMRC scale and CAT score. 4 months of follow up
Secondary Outcome assess the compliance of COPD patients to respiratory rehabilitation at home. assess respiratory exacerbation rate and severity during respiratory rehabilitation . assess prognosis impact of respiratory rehabilitation through BODE index. 4 months after respiratory rehabilitation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abderrahmen Mami hospital rue de lhopital. Ariana 2080 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Nidhal BELLOUMI service de pneumologie pavillon 4, hopital abderrahmen mami, 2 rue de lhopital ariana 2080 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor service de pneumologie Pavillon 4 hopital Abderrahmen mami 2 rue de lhopital ariana 2080 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
imen bachouche 2 rue de lhopital ariana 2080 Tunisia
fatma chermiti 2 rue de lhopital ariana 2080 Tunisia
soraya fenniche 2 rue de lhopital ariana 2080 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nidhal belloumi nidhalbelloumi@gmail.com +21620456190 hopital abderrahmen mami 2 rue de lhopital
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de pneumologie Pavillon 4
Role Name Email Phone Street address
Scientific Enquiries soraya fenniche soraya.fenniche@rns.tn +21670160300 2 rue de lhopital abderrahmen mami
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de peumologie Pavillon 4
Role Name Email Phone Street address
Public Enquiries imen bachouche imenebachouche@yahoo.fr +21670160300 2 rue de lhopital abderrahmen mami
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de pneumologie Pavillon 4
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available on request to the author for any purpose, immediately after publication , there will be no end date Analytic Code,Statistical Analysis Plan,Study Protocol immediately after publication , no end date individual participant data will be available, with no restrictions, on request to the author for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/03/2021 01/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchgate.net/project/respiratory-rehabilitation-programme-applied-at-home-for-COPD-patients
Changes to trial information