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.: PACTR201910562118957 Date of Approval: 21/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of exercise training on bone mineral density and some health-related outcomes in HIV conditions: a randomised controlled trial
Official scientific title Effects of exercise training on bone mineral density and some health-related outcomes in HIV conditions: a randomised controlled trial
Brief summary describing the background and objectives of the trial One of the common problems associated with HIV is reduced bone mineral density. The relationship between a reduced bone mineral density and HIV is multi-factorial, although the major related patho-genesis is that HIV infection alters bone metabolism, and this is further compounded with long term use of HAART (Kruger and Nell, 2017, Shiau et al., 2018, Vlot et al., 2018). The risk of osteoporosis is increased by 1.6 in HIV positive individuals when compared with HIV negative individuals (Brown and Qaqish, 2006). Apart from HIV and several other risk factors that predispose reduced bone mineral density, immobilization as a result of fracture is also a predisposing factor (Ceroni et al., 2012). Also, the consequent immobilization of the affected individuals should translate to loss of independence in activities of daily living, limited functional capacity, loss of economic independence and poor quality of life (Mkandla et al., 2016). These challenges could minimize functional mobility with an adverse impact on socialization resulting in restricted social participation. Therefore, any interventions that could prevent ameliorate or reverse the adverse effects of HIV and antiretroviral therapy - related bone demineralization should be of socio-economic significance. The aim of the study will be to determine the effects of exercise training on bone mineral density and some health-related outcomes in people living with HIV with femoral shaft fracture: a randomized controlled trial in Nigeria & South Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Rehabilitation
Anticipated trial start date 02/01/2020
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Home based exercise intervention Twelve weeks The intervention program consist of muscle strengthening exercises, weight bearing exercises, proprioception training, balance and gait training. 200
Control Group Regular physiotherapy management Twelve weeks The intervention consists of regular physiotherapy management post fracture reduction. 200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Only patients between 18 - 60 years at the last birthday and not more than 60 years at the next birthday. 2. For HIV - negative participants, willingness to accept HIV testing. 3. All patients on ART therapy and with end of stage fracture healing will be recruited. 4. All patients with lower limb fractures (femur) will be recruited. 5. All patients must be ambulant 1. Presence of any bone or rheumatic disorder. 2. Fracture of the femoral neck Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 04/10/2019 Human Research Ethics Committee University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
7 York road, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bone mineral density Baseline, six weeks, 12 weeks and 6 months post surgery
Secondary Outcome The secondary outcome measures are bone turnover, functional capacity, health related quality of life, gait, inflammation, physical activity, coping and exercise adherence The secondary outcome measures will be measured at baseline, six weeks, 12 weeks and six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Hospital Soweto Johannesburg South Africa
Enugu State University Teaching Hospital Enugu Enugu Nigeria
Parklane Hospital Enugu Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand 7 York road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hellen Myezwa hellen.myezwa@wits.ac.za +27781781423 7 York road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Head of School
Role Name Email Phone Street address
Public Enquiries Adedayo Ajidahun tunde.ajidahun@wits.ac.za +27781781423 7 York road
City Postal code Country Position/Affiliation
Johannesburg South Africa Postdoctoral Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Sam Ibeneme sam.ibeneme@unn.edu.ng +27781781423 7 York road
City Postal code Country Position/Affiliation
Enugu Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial will be de-identified and will be made available to researchers upon request. Study Protocol The data will be made available from between 6 months and 5 years following article publication. Researchers with an intent of use of the de-identified individual data will be required to submit a research proposal approved by an independent review committee. The researchers will need to sign a data access agreement form and all inquiries should be directed to hellen.myezwa@wits.ac.za.
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