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.: PACTR201403000774191 Date of Approval: 18/02/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The functional impact of a non-pharmacological intervention for musculoskeletal conditions in women with co-morbidities
Official scientific title The functional impact of a non-pharmacological and contextually relevant intervention for musculoskeletal conditions in women with associated co-morbidities at community health centres in Cape Town
Brief summary describing the background and objectives of the trial WHO found that osteoarthritis (OA) were the 8th leading cause of non-fatal burden in the world in 2000, impacting functional activities of millions of people around the world (Page, Hinman, & Bennell, 2011). In South Africa, a high (76%) prevalence of arthritis, OA (10%) and rheumatoid arthritis, (RA) (5%) was found in Community Health Centres (CHCs) in Cape Town (Parker & Jelsma, 2010). Majority of middle aged women (80%) had reported musculoskeletal conditions. In addition, common comorbidities such as hypertension (59%), diabetes (type II) (25%) and heart problems (19%) were found(Parker & Jelsma, 2010). The potential co-existence of MSD and CDL in women creates an added burden on the under-resourced primary health care facilities in South Africa, as it is the first point of contact for public medical care. Physiotherapy is often recommended for the assessment and management of chronic MSD. However, there seems to be a paucity of evidence- based, contextually appropriate, biopsychosocial interventions for middle- aged women with chronic MSD and associated CDL at primary health care institutions in South Africa. The purpose of this study is to improve the functional level and wellness of disadvantaged middle-aged women with chronic MSD and associated CDL in Cape Town, South Africa. Aim and objectives: To establish whether the intervention has a significant impact on functional ability, physical activity, pain, health- related quality of life, anthropometry, physiological measures, self-efficacy by evaluating: WHODASII, Simmonds battery, pedometers, EQ5D, BPI,BMI, blood pressure and blood glucose levels.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied chronic musculoskeletal conditions, hypertension, diabetes mellitus, cardiovascular disease, obesity,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2014
Actual trial start date
Anticipated date of last follow up 12/06/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HREC/REF:093/2014 Faculty of Health Sciences Human Research Ethics Committee - University of Cape Town
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 Stratified allocation to ensure that there is a 50% representation of participants from the exercise clubs and the chronic care clubs. Central randomisation by phone/ fax or email Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Impact of non-pharmacological intervention on function in women with musculoskeletal conditions 2 hours once a week 6 weeks The participants in the experimental group will be facilitated by the researcher through a two hour exercise and education session using a wellness workbook on a weekly basis. 120
Control Group Impact of non-pharmacological intervention on function in women with musculoskeletal conditions 3 sessions for outcome measures only 6 weeks The control group will not participate in the intervention but will have three sessions to complete outcome measures at week 0, week 6 and week 12. The control group will continue with usual care at the commununity health centre. 120 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women between the ages 45 and 64 attenfing the chronic care club and exercise groups at physiotherapy diagnosed with MSD and CDL, who have been attending the clubs for one month or more will be included. Participants should be able to read and write at a senior phase level (Grades 7-9) in English, Afrikaans or isiXhosa to understand the work book; write goals for weekly exercise; record activities in exercise diaries and answer questionnaires. Do not meet the minimum standards for safe participation in exercise as established through the use of the American College of Sports Medicine Screening instrument. Acute HIV disease manifestations as recorded in their medical folders. Started on Anti-retroviral medication or TB treatment within the last three months. Traumatic joint injuries, or immobilized in a cast/external fixation or had surgery. Pregnant Communication difficulties due to cognitive impairments. Are currently receiving any kind of ¿hands on¿ physiotherapy treatment, as this could imply that the patient¿s condition is unstable. 45 Year(s) 64 Year(s) Female
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 10/02/2014 Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Main Building Groote Schuur Hospital Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional ability assessed by WHODAS II. Outcome measured at 0 weeks Re-evaluation at week 6 Re-evaluation at week 12
Secondary Outcome Physical activity levels measured by the international physical activity questionnaire Outcome measured at 0 weeks, Re-evaluated at 6 and 12 weeks
Secondary Outcome Health related quality of life measured by EQ-5D Outcome measured at 0 weeks, Re-evaluation at 6 and 12 weeks
Secondary Outcome Pain interference measured by the Brief Pain Inventory Outcome measured at 0 weeks, Re-evaluation at 6 and 12 weeks
Secondary Outcome Obesity measured by Body Mass Index Outcome measured at 0 weeks, Re-evaluated at 6 and 12 weeks
Secondary Outcome Confidence in managing chronic disease measured by Stanford Chronic disease Self efficacy scale Outcome measured at 0 weeks, Re-evaluated at week 6 and 12
Secondary Outcome Differences in physiological measures such as blood pressure and blood glucose serum levels Outcomes measured at 0 weeks, Re-evaluated at 6 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Retreat Community Health Centre Eleventh Avenue Cape Town 8000 South Africa
Vanguard Community Health Centre Candlewood Street Cape Town 7764 South Africa
Elsies River Community Health Centre Cnr. Halt Road & 29th Avenue Cape Town 8000 South Africa
Heideveld Community Health Centre Heideveld Road Cape Town 7764 South Africa
Mitchells Plain Community Health Centre First Avenue Cape Town 7785 South Africa
Gugulethu Community Health Centre Cnr NY3 & NY77 Cape Town 7750 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Thuthuka award Meiring Naude Rd Pretoria 0081 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Cape Town Lovers walk Street Cape Town 7701 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Romy Parker Old Main Building, Groote Schuur Hospital Observatory Cape Town 7925 South Africa
Prof Jennifer Jelsma Old Main Building, Groote Schuur Hospital Observatory Cape Town 7925 South Africa
Prof Meredith Harris 360 Huntington Avenue Boston MA 02115 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Candice Hendricks candice.hendricks@uct.ac.za 0847516692 Old Main Building, Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Lecturer in Physiotherapy
Role Name Email Phone Street address
Public Enquiries Candice Hendricks candice.hendricks@uct.ac.za 0847516692 Old Main Building, Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Lecturer in Physiotherapy
Role Name Email Phone Street address
Scientific Enquiries Jennifer Jelsma jennifer.jelsma@uct.ac.za 021-4066401 Old Main Building, Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Professor
REPORTING
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