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.: PACTR201706002153458 Date of Approval: 30/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of pulmonary rehabilitation programme for patients with TB to improve lung function and functional outcomes.
Official scientific title Impact of a pulmonary rehabilitation intervention to improve lung function and functional outcomes of patients with pulmonary tuberculosis in a high HIV prevalent setting.
Brief summary describing the background and objectives of the trial Pulmonary rehabilitation is not a novel intervention for the treatment of patients suffering from smoking-related chronic obstructive pulmonary disease (COPD) and has long been established as an appropriate and effective method of management for this condition. Generally TB has not been included in this grouping as it was not seen as a cause of COPD. It is only in the last decade that research has shown that TB patients post successful completion of drug therapy present with COPD. Even though pulmonary impairment is evident post TB cure uptake of these findings into clinical practice has been slow. Pulmonary rehabilitation, or additional care to address poor lung function or impaired functional ability arising from decreased lung function post-TB, to the researcher¿s knowledge, is non-existent in the South African context, despite the high TB burden. In a recent non-systematic review conducted by Munoz-Toricco et al (2016), who posed the question ¿Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis?¿, the authors concluded that there is a rationale for providing pulmonary rehabilitation for patients suffering from post-tuberculosis sequelae as it is evident that tuberculosis is responsible for causing primarily an obstructive pattern on spirometry but also restrictive and mixed patterns. Objectives of the trial are: ¿ Measure baseline parameters pertaining to lung function, functional capacity and quality of life, prior to enrolment into RCT at 0 months (time of TB diagnosis)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Other
Anticipated trial start date 03/07/2017
Actual trial start date
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 randomisation using a radomisation table created by a computer software program Allocation 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 Pulmonary rehabilitation programme (PRP) 3 times a week 45- 60minutes Pulmonary and aerobic exercises followed by educational session 30
Control Group No intervention once Once provided with information about TB as well as education on smoking cessation and healthy living 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Current pulmonary TB only with or without previous episodes of TB or COPD confirmed with gene expert/smear positive ¿ Adults 18 -65 years of age ¿ Must have infiltrate of at least one area on CXR ¿ Must pass screening tool for starting exercise program ¿ Must be compliant with TB medication ¿ No extra-pulmonary TB ¿ No asthma, recent chest trauma (last 3 months) or pneumonia ¿ No existing cardiac disease 18 Year(s) 65 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
No 01/05/2017 Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Rondebosch Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lung function parameters-FEV1, FVC and FEV1/FVC For all outcome measures: At enrollment At 6 weeks into the intervention (midway) At 12 weeks (completion of intervention) At 3 months post intervention At 6 months post intervention At 1 year post intervention
Secondary Outcome Quality of life and 6 minute step test-EQ5D score and SGRQ For all outcome measures: At enrollment At 6 weeks into the intervention (midway) At 12 weeks (completion of intervention) At 3 months post intervention At 6 months post intervention At 1 year post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Michael Mopongwana Khayelitsha Cape Town South Africa
Ubuntu Site B Khayelitsha Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Seyi Amosun Old Main Building, F56, Room 71, Groote Schuur Hospital, observatory Cape Town 7925 South Africa University
Secondary Sponsor Prof. Graeme Meintjes Anzio road Cape Town 7925 South Africa University
Secondary Sponsor Ass. Prof Brian Allwood Stellenbosch University Cape Town South Africa University
COLLABORATORS
Name Street address City Postal code Country
N/A
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyi Amosun Seyi.amosun@uct.ac.za (021)406-6992 Old Main Building, F56, Room 71, Groote Schuur Hospital, observatory
City Postal code Country Position/Affiliation
Cape town 8000 South Africa Primary supervisor
Role Name Email Phone Street address
Public Enquiries Shamila Manie shamila.manie@uct.ac.za 0832251736 72 Dale Street, Rondebosch East
City Postal code Country Position/Affiliation
Cape Town 7780 South Africa Study Researcher
Role Name Email Phone Street address
Scientific Enquiries Shamila Manie shamila.manie@uct.ac.za 0832251736 72 Dale Street, Rondebosch East
City Postal code Country Position/Affiliation
Cape Town 7780 South Africa Study Researcher
REPORTING
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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