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.: PACTR201807847711940 Date of Approval: 10/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Patient-centred lifestyle rehabilitation for non-communicable disease in a low-resource setting
Official scientific title Patient-centred lifestyle rehabilitation for non-communicable disease in a low-resource setting: a feasibility and proof-of-concept randomized clinical trial
Brief summary describing the background and objectives of the trial South Africa and other Low-to-Middle Income (LMIC) countries are facing evolving health care needs from predominantly communicable to non-communicable diseases (NCD). In a high-income setting, rehabilitation is a well-established evidence-based treatment modality for NCD yet this model is unlikely translated into a low-resource, public health care, sector. Hence, there is a dearth of robust evidence and knowledge about how to (cost)effectively deliver and study patient-centred rehabilitation for NCDs within a low-resource setting. The aim of this study is to i) test the feasibility and key characteristics of a minimalistic patient-centred rehabilitation intervention that is designed specifically for the low-resource setting and ii) Inform the research methodology and study design for a full scale randomized clinical trial on the effectiveness of patient-centred rehabilitation for NCD in a low-resource setting.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Cardiology,Circulatory System,Nutritional, Metabolic, Endocrine,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 17/09/2018
Actual trial start date 12/12/2018
Anticipated date of last follow up 20/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Ethics ID: M17/09/031
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Patient-centred Lifestyle Rehabilitation Weekly supervised exercise; two home-based exercise sessions/week, and three health-education sessions. One hour per session 6 weeks Individualised exercise prescription to target 150 min/week moderate-to-vigorous intensity physical activity plus targeted health-education to address risk factors for non-communicable disease 150
Control Group Usual Care Usual Care 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. At least 18 years of age or older (i.e. adult) 2. Able to perform in some weight-bearing or non-weight-bearing exercise 3. Minimal of one confirmed diagnosis according to the WHO classification of: cardiovascular disease (ICD: I0-99), chronic respiratory disease (ICD:J30-98), Malignant neoplasms (ICD: C00-97), or diabetes (E10-E14; excluding those with complications [minus E10.2-E10.29, E11.2-E11.29, E12.2, E13.2- E13.29, E14.2]) 1. No generic contraindications for exercise training or disease-specific contraindications for exercise training (according to American College of Sports Medicine guidelines) 2. Other contraindications for exercise prescription as determined by the medical practitioner. 3. Structured exercise training at regular intervals (more than once per week) at a moderate-to-vigorous intensity in the previous 3 months. 4. Psychiatric, substance abuse or known history of violence that would jeopardize the safe conduct of this program. 5. Pregnancy 18 Year(s) 100 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 16/05/2018 Health Research and Ethics Committee 2
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University, Faculty of Health and Medicine Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility outcomes (eligible patients, participant and retention rate, group-allocation ratio, drop-out rate, and treatment adherence) Baseline 8 weeks 16 weeks
Secondary Outcome Physical examination (e.g. BMI, Blood Pressure, Lung Spirometry) Baseline 8 weeks 16 weeks
Secondary Outcome Lifestyle risk factors (e.g. Smoking, Alcohol abuse) Baseline 8 weeks 16 weeks
Secondary Outcome 6-Minute Walk Test (6MWT) Baseline 8 weeks 16 weeks
Secondary Outcome Pittsburg Quality of Sleep index Baseline 8 weeks 16 weeks
Secondary Outcome International Physical Activity Questionnaire Baseline 8 weeks 16 weeks
Secondary Outcome EQ-5D-5L Baseline 8 weeks 16 weeks
Secondary Outcome Timed Up & Go test Baseline 8 weeks 16 weeks
Secondary Outcome Six-Spot-Step test Baseline 8 weeks 16 weeks
Secondary Outcome Patient-perspective cost-benefits (includes transportation costs, productivity cost questionnaire, direct medical costs) Baseline 8 weeks 16 weeks
Secondary Outcome Treatment adherence 8 weeks
Secondary Outcome Treatment Fidelity Baseline to 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bishop Lavis day clinic Lavis drive Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
AXA Research Fund 25 Avenue Matignon Paris 75008 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Physiotherapy, Stellenbosch University Francy van Zyl drive Cape Town 8000 South Africa University
Primary Sponsor Institute of Sports and Exercise Medicine, Stellenbosch University Francy van Zyl drive Cape Town 8000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Martin Heine, PhD Dept. of Physiotherapy / ISEM, Stellenbosch University, Francy van Zyl drive Cape Town 8000 South Africa
Prof. Wayne Derman, MD, PhD Institute of Sports and Exercise Medicine (ISEM), Stellenbosch University, Francy van Zyl drive Cape Town 8000 South Africa
Prof. Susan Hanekom, PhD Dept. of Physiotherapy, Stellenbosch University, Francy van Zyl drive Cape Town 8000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martin Heine mheine@sun.ac.za +27760768342 Stellenbosch University, Faculty of Health and Medicine, Francy van Zyl drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa AXA Post Doctoral Research Fellow
Role Name Email Phone Street address
Public Enquiries Martin Heine mheine@sun.ac.za +27760768342 Stellenbosch University, Faculty of Health and Medicine, Francy van Zyl drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa AXA post doctoral research fellow
Role Name Email Phone Street address
Scientific Enquiries Martin Heine mheine@sun.ac.za +27760768342 Stellenbosch University, Faculty of Health and Medicine, Francy van Zyl drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa AXA post doctoral research fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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