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.: PACTR201507001186115 Date of Approval: 01/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECTS OF A SIX-WEEK PHYSIOTHERAPIST-LED EXERCISE AND EDUCATION INTERVENTION IN PATIENTS WITH OSTEOARTHRITIS AWAITING ARTHROPLASTY IN GAUTENG
Official scientific title THE EFFECTS OF A SIX-WEEK PHYSIOTHERAPIST-LED EXERCISE AND EDUCATION INTERVENTION IN PATIENTS WITH OSTEOARTHRITIS AWAITING ARTHROPLASTY IN GAUTENG
Brief summary describing the background and objectives of the trial In South Africa there are extensive waiting lists for osteoarthritis related arthroplasty which has negative consequences with suffering with chronic pain and its impact. This study aimed to determine the effects of a six-week physiotherapy-led exercise and education intervention in patients with osteoarthritis, awaiting a hip or knee arthroplasty. The objectives were to determine whether participating in a six-week physiotherapist-led exercise and education intervention, resulted in a significant change in the following outcomes, when compared to the control group, in patients with OA awaiting a hip or knee replacement: Pain severity and pain interference as measured on the Brief Pain Inventory (BPI). Disability as measured by the Stanford Health Assessment Questionnaire (HAQ-8). Function as measured by the Physical Performance task battery. Self-efficacy as measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale. Health-related quality of life as measured by the EQ-5D. In addition; to determine whether body mass index (BMI or the presence of OA of the knee or OA of the hip accounts for any significant differences in the above outcome measures. Finally, to determine the acceptability of a six-week physiotherapist-led exercise and education intervention for patients on the waiting list for joint arthroplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Osteoarthritis, Chronic Pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/01/2014
Actual trial start date 15/01/2014
Anticipated date of last follow up 01/09/2014
Actual Last follow-up date 22/09/2014
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 32
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HREC REF: 492/2013 human research ethics committee
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 Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercise and Education Intervention for OA 2,5 hours once per week 6 weeks each session consisted of: an educational component relating to OA - pain physiology, disease specifics, lifestyle changes, medication use, stress management and goal setting. An exercise component: aerobic, strengthening and stretching and CBT with visualisation with contract/relax of major muscle groups and mindfullness 15
Control Group Control group for "Exercise and Education Intervention for OA" the control group would not participate in the intervention, but would continue to receive their normal medical care. the control group would as the experimental group have outcomes measured at week 0, 6, 12 and 6 months 17 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients from Helen Joseph Hospital, Gauteng Aged 50 ¿ 70 years Diagnosed with OA of one of the lower extremities: Knee or hip Waitlisted for arthroplasty of the affected joint. Can comprehend and literate in English, Afrikaans or isiZulu. Minimum of 3 months on the waiting list. Previous trauma/ surgery to the unaffected limb. Diagnosis of bilateral lower limb arthritis as per the waiting list information, i.e. if a patient is on the waiting list for bilateral surgery and / or has been diagnosed with other conditions of the lower limb that may be attributing to the symptoms. Information confirmed during the initial telephonic interview and recorded in medical records. Cognitive impairment as recorded in the medical records. 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 20/08/2013 Human Ethics Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road cape town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Severity and Interference Baseline - week 0 Week 6 Week 12 Month 6
Secondary Outcome Disability as measured by the Stanford Health Assessment Questionnaire Baseline - Week 0 Week 6 Week 12 Month 6
Secondary Outcome Function as measured by the Physical Performance task battery Baseline - Week 0 Week 6 Week 12 Month 6
Secondary Outcome Self-efficacy as measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale Baseline - Week 0 Week 6 Week 12 Month 6
Secondary Outcome Health-related quality of life as measured by the EQ-5D Baseline - Week 0 Week 6 Week 12 Month 6
Secondary Outcome Body Mass Index Baseline - week 0 W eek 6 Week 12 Month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Helen Joseph Hospital Perth Road Joahnnesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UCT Postgraduate funding Anzio Road Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Margaret Roper Scholarship UCT, Anzio Road Cape Town 7925 South Africa Charities/Societies/Foundation
Primary Sponsor UCT Postgraduate Funding Anzio Road Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
University of Cape Town Anzio Road Cape Town 7925 South Africa
Helen Joseph Hospital Perth Road Johannesburg 2196 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tina kruger-jakins tkruger-jakins@icas.co.za 0734886801 85 bonnie place
City Postal code Country Position/Affiliation
johannesburg 2196 South Africa Physiotherapist
Role Name Email Phone Street address
Public Enquiries Crystal August crystal.august@uct.ac.za 0214066115 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Postgraduate administrative officer
Role Name Email Phone Street address
Scientific Enquiries romy parker romy.parker@uct.ac.za 0214066431 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa A/Prof Physiotherapy dept HOD
REPORTING
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