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.: PACTR201405000823418 Date of Approval: 08/05/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Whole Body Vibration in Rheumatoid Arthritis
Official scientific title Whole Body Vibration in Rheumatoid Arthritis
Brief summary describing the background and objectives of the trial Background: Rheumatoid arthritis (RA) is a chronic autoimmune condition that results in pain and disability. Patients with RA are may be forced into a sedentary lifestyle and, as such, often become predisposed to poor bone health. Patients with RA may also experience a decreased health related quality of life (HRQoL) due to their disease. Whole body vibration (WBV) is a form of exercise that stimulates bone loading through forced oscillation. WBV has also been shown to decrease pain and fatigue in other rheumatic diseases, as well as to increase muscle strength. This paper reports on the development of a semi randomised controlled clinical trial to assess the impact of a WBV intervention aiming to attenuate bone loss, improve functional ability and habitual physical activity levels in patients with RA. Methods and Design: This study is a controlled clinical trial consisting of a cohort of patients with established RA assigned to either a WBV group or a CON (control) group. Patients in the WBV group will undergo three months of twice weekly intermittent WBV sessions, while the CON group will receive standard care and continue with normal daily activities. All patients will be assessed at baseline, following the three month intervention, and six months post intervention. Main outcomes will be an attenuation of loss of bone mineral density (BMD) at the hip and changes in RA disease activity, HRQoL, habitual physical activity levels and body composition. Discussion: This study will provide important information regarding the effects of WBV on BMD in patients with RA, as well as novel data regarding the potential changes in objective habitual physical activity patterns that may occur following the intervention. The sustainability of the intervention will also be assessed.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Rheumatoid arthritis, osteoporosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 20/02/2014
Actual Last follow-up date 20/02/2014
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 31
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered allocation Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Whole body vibration (WBV) twice per week 12 weeks Vibration training will consist of 24 total sessions (performed twice weekly for 12 weeks); in intermittent bouts of 60 seconds on the plate and 30 seconds off the plate, repeated 10 times (this protocol was designed to stimulate greater osteogenic responses due to the constant stimulus to the mechanoreceptors). Patients will be required to stand on the plates, barefoot and with knees slightly ben 16 Active-Treatment of Control Group
Control Group Control group (CON) NA 12 weeks The CON group will continue to receive standard care for the intervention period, and will be instructed to continue with their normal daily activities for the three month period. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Older than 18 years Have been diagnosed with RA (according to the 1987 ACR criteria) at least three years previously On stable drug therapy (prednisone <10mg/day) Had been on stable drug therapy for at least three months previously. HIV+ Using bisphosphonates or corticosteroids Have any co-morbidities that could potentially impact on physical activity levels Using assistive walking devices Have previously had hip or knee joint replacement surgery Are pregnant. 18 Year(s) 100 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 18/02/2013 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Senate House, 1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bone mineral density Baseline Follow up (three months post baseline) Post intervention (six months post baseline)
Secondary Outcome Functional ability Baseline Follow up (three months post baseline) Post intervention (six months post baseline)
Secondary Outcome Physical activity Baseline Follow up (three months post baseline) Post intervention (six months post baseline)
Secondary Outcome Health related quality of life Baseline Follow up (three months post baseline) Post intervention (six months post baseline)
Secondary Outcome Body composition Baseline Follow up (three months post baseline) Post intervention (six months post baseline)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath AcademicHospital 26 Chris Hani Road, Soweto Johannesburg 2013 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Connective Tissues Research Grant
National Research Foundation
Carnegie Large Research Grant
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alessandra Prioreschi 7 York Road Parktown Johannesburg 2009 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Amin Makda 26 Chris Hani Road, Soweto Johannesburg 2013 South Africa
Mohammed Tikly 26 chris Hani Road, Soweto johannesburg 2013 South Africa
Joanne McVeigh 7 York Road Parktown Johannesburg 2009 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alessandra Prioreschi alessandraprioreschi@gmail.com 0839890070 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2009 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Alessandra Prioreschi alessandraprioreschi@gmail.com 0839890070 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2009 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Mohammed Tikly drmohammed@gmail.com +27119339377 26 Chris Hani road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 2013 South Africa Head of Rheumatology
REPORTING
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