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.: PACTR201409000885765 Date of Approval: 12/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effects of a six-week exercise and education programme in people with arthritis awaiting a joint replacement, in South Africa.
Official scientific title The effects of a six-week physiotherapist-led exercise and education intervention in patients with osteoarthritis awaiting an arthroplasty, in the Western Cape, South Africa.
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is one of the leading causes of disability worldwide. A major challenge facing this population, in both low and high income countries, is long waiting lists delaying access to joint replacements. Patients are known to wait more than 5 years for a joint replacement in the Western Cape of South Africa (SA). The main complaint in this population is pain and its consequences including reduced quality of life and participation restrictions. Hip or knee OA is not merely joint degeneration but a condition requiring holistic management, even while waiting for surgery. Most of the literature in this field of research is available from high income countries exploring the effects of interventions during short waiting periods; research is warranted in a low income country such as SA in those waiting for long periods. The aim is to explore the effects of a six-week physiotherapist-led exercise and education intervention in patients with hip or knee OA who have been placed on a long waiting list for an arthroplasty in SA. The objective of the trial is to determine in a group of patients with knee or hip OA, awaiting a joint replacement, whether participating in a six-week physiotherapist-led exercise and education intervention, results in a significant change in the following outcomes, when compared to the control group: 1. Pain severity and pain interference as measured on the Brief Pain Inventory (BPI). 2. Disability as measured by the Stanford Health Assessment Questionnaire (HAQ). 3. Function as measured by the Physical Performance task battery. 4. Self-efficacy as measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale. 5. Health-related quality of life as measured by the EQ-5D. In addition, to determine whether or not body mass index values account for any significant differences in the above outcome measures. And lastly to explore patients¿ views on the intervention by asking a short open ended questionnaire afterwards.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/10/2013
Actual trial start date 15/10/2013
Anticipated date of last follow up 01/07/2014
Actual Last follow-up date 15/07/2014
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UCT Faculty of Health Sciences Human Resource Ethics Committee 378-2013
UCT Faculty of Health Sciences Human Resource Ethics Committee 378-2013
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 A random sample was drawn from the patients on the third priority list by means of random number selection in Excel (computer software program). The final sample was stratified according to hip or knee OA and then randomly allocated via Excel into the intervention or control group. allocation was determined using codes for patients and the holder of the sequence did not know which codes were which patient. Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised A random sample was drawn from the patients on the third priority list by means of random number selection in Excel (computer software program). The final sample was stratified according to hip or knee OA and then randomly allocated via Excel into the intervention or control group. allocation was determined using codes for patients and the holder of the sequence did not know which codes were which patient. Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 6-week physiotherapist-led exercise and education programme two hours a week six weeks One hour of education, led by a physiotherapist, covering various aspects of living with OA. 20 - 30 minutes of exercise comprising stretching, light aerobic exercise and general strengthening. 15 -20 minute relaxation component by means of visualisation exercises 20
Control Group Usual care daily six weeks Participants continued to receive their usual care while being on the waiting list, no aspects were added or removed. This could have included doctor's appointments, medication usage. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Willingness to commit to the study (signed informed consent document) Aged 50 ¿ 70 years Diagnosed with OA of the hip/knee On the waiting list for a minimum of three months Can comprehend and are literate in English or Afrikaans or isiXhosa Previous trauma/ surgery to the unaffected leg Cognitive impairment Do not meet the American College of Sports Medicine (ACSM) guidelines for exercise prescription Those who have taken part in a 6-week programme aimed at improving self-efficacy and management previously 50 Year(s) 70 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 15/07/2013 University of Cape Town, Faculty of Health Sciences Human Resource Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Main Building of Groote Schuur Hospital, Floor E52, Room 23, Observatory Cape Town 7925 South Africa
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 15/07/2013 UCT faculty of Health Science Human Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
ROom E52-24 Groote Schuur hospital old main building Observatory Cape town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity and interference measured by the Brief Pain Inventory Baseline Week 6 Week 12 Month 6
Secondary Outcome Disability measured by the Stanford Health Assessment Questionnaire Baseline Week 6 Week 12 Month 6
Secondary Outcome Function measured by the Physical Performance Task Battery Baseline Week 6 Week 12 Month 6
Secondary Outcome Health related quality of life measured by the EQ-5D Baseline Week 6 Week 12 Month 6
Secondary Outcome Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale Baseline Week 6 Week 12 Month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie Van Zijl Drive, Parow Tygerberg 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Society of Physiotherapy Unit 4, Parade on Kloof Office Park Bedfordview 2007 South Africa
University of Cape Town Supervisor funds Old Main Building of Groote Schuur Hospital, Floor F54, Observatory Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor South African Society of Physiotherapy Unit 4, Parade on Kloof Office Park Bedfordview 2007 South Africa Commercial Sector/Industry
Secondary Sponsor Tygerberg Hospital Francie Van Zijl Drive, Parow Cape Town 7505 South Africa Hospital
Primary Sponsor Dr Romy Parker Old Main Building of Groote Schuur Hospital, Floor F54, Observatory Cape Town 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Miss Melissa Saw Tygerberg Hospital, Franci Van Zijl Street Cape Town 7505 South Africa
Dr Romy Parker Old Main Building of Groote Schuur Hospital, Floor F54, Observatory Cape Town 7925 South Africa
Mrs Naila Edries Old Main Building of Groote Schuur Hospital, Floor F54, Observatory Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melissa Saw melissasaw07@gmail.com +27219385152 Francie Van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Postgraduate Physiotherapy student and Grade 1 physiotherapist
Role Name Email Phone Street address
Public Enquiries Melissa Saw melissasaw07@gmail.com 27219385152 Franci Van Zijl Street, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Postgraduate Physiotherapy student and Grade 1 physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Romy Parker Romy.Parker@uct.ac.za +27214066571 Old Main Building of Groote Schuur Hospital, Floor F54, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior lecturer
REPORTING
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