Trial no.:	PACTR201712002889203	Date of Approval:	19/12/2017
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Effects of maximal strength exercise on bone mineral density in people living with HIV and receiving ART: A randomised controlled trial

Official scientific title

Maximal strength exercise training and bone mineral density in HIV

Brief summary describing the background and objectives of the trial

Despite benefits of increased survival, prolonged use of antiretroviral therapy (ART) regimens in HIV patients is associated with low bone mineral density (BMD). Low BMD is characterised by osteopenia and osteoporosis which predispose people living with HIV (PLWHIV) to future fall related fractures thereby increasing the risk for morbidity and mortality. Strategies to manage reduced BMD, osteopenia and osteoporosis include providing vitamin D and calcium supplements as well as pharmacological therapies. However, these pharmacological therapies are associated with adverse effects such as tumors, infection, nasopharyngitis, osteosarcoma as well as bronchitis which limit their recommendation for use in HIV infected individuals. In addition, the current cost of treating bone loss using pharmacological therapies such as bisphosphonates is prohibitive. Further, pharmacological therapies may increase the pill burden in PLWHIV who are already burdened by ART. Therefore, it is important to adopt effective non pharmacological strategies to prevent and treat low BMD in PLWHIV. The purpose of this study is to determine the effects of maximal strength exercise on BMD among PLWHIV and on ART in Malawi. A randomised controlled study involving HIV-positive adults recruited from Queen Elizabeth Central Hospital in southern Malawi will be adopted. Data on BMD will be collected using DEXA scans. Participants with low BMD will then be randomised into either exercise or control group. Variables of body mass index (BMI), Peak oxygen uptake (VO2max). Peak heartrate, Blood pressure, BMD and 1 repetition maximum (1RM) will be obtained before and after exercise training to determine improvements.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Infections and Infestations

Sub-Disease(s) or condition(s) being studied

HIV/AIDS

Purpose of the trial

Physical activity and nutrition

Anticipated trial start date

03/09/2018

Actual trial start date

03/09/2018

Anticipated date of last follow up

03/12/2018

Actual Last follow-up date

03/12/2018

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

Recruitment status

Recruiting

Publication URL

N/A

Secondary Ids	Issuing authority/Trial register
N/A	N/A

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	Stratified allocation (age matched and gender)	double blind (sealed envelops)	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Maximal strength exercise group	4 sets of 3 - 5 repetitions at 85% to 90% of 1 repetition maximum weight	3 times / week for 12 weeks		20
Control Group	control group	sedentary (business as usual)	12 weeks		20

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Only those who volunteer to participate in the study will be recruited. Male and female participants living with HIV and receiving ART aged between 18 and 45 years. Only those receiving tenofovir based ART regimens for more than one year. Age 18 to 45 years old	Those with cardiac, respiratory and renal diseases. Smokers, alcoholics, diabetic and hypertensive. All those who are highly physically fit (VO2max of above 30 ml/kg/min).		18 Year(s)	45 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

25/09/2017

College of Medicine Research Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
College of Medicine. Private Bag 360	Blantyre	+265	Malawi

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Bone mineral density	Before intervention (baseline) post intervention after 12 weeks
Primary Outcome	1 repetition maximum (1 RM)	Before intervention (baseline) post intervention after 12 weeks
Secondary Outcome	Maximal oxygen uptake (VO2max)	Before intervention (baseline) Post intervention after 12 weeks
Secondary Outcome	Blood pressure	Before intervention (baseline) Post intervention after 12 weeks
Secondary Outcome	heartrate	Before intervention (baseline) Post intervention after 12 weeks
Primary Outcome	Age	Before intervention (baseline)
Primary Outcome	Height	Before intervention (baseline) Post intervention after 12 weeks
Primary Outcome	Body weight	Before intervention (baseline) Post intervention after 12 weeks

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Antiretroviral Therapy Clinic of Queen Elizabeth Central Hospital	P.O. Box 95. Off Mahatma Ghandi Road	Blantyre	+265	Malawi

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Consortium for Advanced Research Training in Africa (CARTA)	P.O. Box 10787 - 00100.	Nairobi	N/A	Kenya

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	Consortium for Advanced Research Training in Africa (CARTA)	APHRC Campus, 2nd Floor, Manga Close, off Kirawa Road, PO Box 10787 00100	Nairobi		Kenya	Funding Agency
Primary Sponsor	University of Malawi College of Medicine	Private Bag 360, Mahatma Ghandi Road	Blantyre		Malawi	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Professor Fanuel Lampiao	Department of Biomedical Sciences. College of Medicine. Private Bag 360. Mahatma Ghandi Campus.	Blantyre	+265	Malawi
Dr. Kennedy Malisita (Head of ART Clinic)	Queen Elizabeth Central Hospital. Off Mahatma Ghandi Road. P.O. Box 95.	Blantyre	+265	Malawi
Professor Demitri Constantinou	UNiversity of the Witswatersrand. JoCenter for Exercise Science and Sports Medicine. Uniersity of the Witswaresrand. P.O. Box 830, Wits 2050.	Johannesburg	+277	South Africa

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Enock Chisati	echisati@medcol.mw	+265888168284	College of Medicine, Department of Physiotherapy, Private Bag 360. Mahatma Ghandi Road.
City	Postal code	Country	Position/Affiliation
Blantyre	+265	Malawi	PhD student and Lecturer in Exercise Physiology
Role	Name	Email	Phone	Street address
Public Enquiries	Kennedy Malisita	ekari988@gmail.com	+265999440965	Queen Elizabeth Central Hospital, Department of Medicine. P.O. Box 95. Off Mahatma Ghandi Road.
City	Postal code	Country	Position/Affiliation
Blantyre	+265	Malawi	Study Collaborator and Head of ART unit
Role	Name	Email	Phone	Street address
Scientific Enquiries	Fanuel Lampiao	flampiao@medcol.mw	+265995482713	College of Medicine, Department of Biomedical Sciences. College of Medicine. Private Bag 360. Mahatma Ghandi Road.
City	Postal code	Country	Position/Affiliation
Blantyre	+265	Malawi	Supervisor and Associate Professor of human Physiology.

REPORTING
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Changes to trial information

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