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.: PACTR202310853413416 Date of Registration: 12/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of exercise therapy on cardiovascular disease (CVD) risk among people living with Human Immunodeficiency Virus in Ndirande, Malawi: A step towards designing a sustainable CVD prevention strategy
Official scientific title Effects of exercise therapy on cardiovascular disease (CVD) risk among people living with Human Immunodeficiency Virus in Ndirande, Malawi: A step towards designing a sustainable CVD prevention strategy
Brief summary describing the background and objectives of the trial The burden of cardiovascular disease (CVD) is on the rise among people living with Human Immunodeficiency virus (HIV) (PLHIV). In addition to the traditional CVD risk factors, antiretroviral regimens and chronically activated immune system and inflammation characteristic of chronic HIV are also independent CVD risks. Although there are more than one million Malawians living with HIV, CVD preventive programs in this population are not routinely carried out. Cross-sectional descriptive, randomized controlled trial and qualitative designs will be employed in phases one, two and three of the study respectively. Broadly, the study aims to describe short-term effects of 14-weeks ET on cardiorespiratory fitness, Framingham 30-year CVD risk score, Cardiovascular health (CVH) score, and quality of life of PLHIV . Specifically, the study aims to: 1. Determine prevalence of dyslipidemia, overweight/obesity, diabetes, and hypertension within a recruited cohort of PLHIV 2. Describe the baseline relationships between CVH status and (i) ART duration, (ii) knowledge on CVD and (iii) Framingham 30-year CVD risk in PLHIV 3. Describe the baseline relationships between the 30-year CVD risk and (i) duration of ART and (ii) arterial function indices among PLHIV 4. Compare the change differences in cardiorespiratory fitness, Framingham 30-year CDV risk scores, and bio- and anthropometric-markers of CVD risk between high CVD risk PLHIV in ET and usual care arms at the end of intervention 5. Describe the relationship between the changes in CRF and the 30-year CVD risk among PLHIV at the end of intervention 6. Assess the participant’s perceived barriers and enablers to accessing and utilizing the CVD preventive interventions
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 16/10/2023
Actual trial start date 30/01/2024
Anticipated date of last follow up 31/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercise therapy Three sessions a week at the hospital, each session lasting an hour. Aerobic and strength exercises will be prescribed at an intensity of 40-80% of heart rate reserve and 60-80% of 1 repetition maximum respectively. Two to three sets of strength training exercises will be run at each designated circuit station, each set comprising of 8-10 repetitions. Both aerobic and strength types of exercises will be run for 24 minutes each on every hospital visit. 14 weeks The exercise therapy shall comprise of both aerobic and strength exercises. The exercises shall involve use of locally available equipment (low cost). Exercises such as box stepping, spot marching, rope skipping, stretches, jogging, weighted-ball throwing, squats and weight lifts will be employed. 20
Control Group individualized education and counselling targeting healthy behaviour change Delivered once via face to face at the hospital, and subsequently once a week via a phone call. 14 weeks Participants will be assessed for knowledge on cardiovascular disease risk factors and disease prevention and cardiovascular disease risk perception. Each participant will also be assessed to identify factors that influence the choices of food they eat and how they prepare it, including their lifestyles. Based on this information, participants will be guided through to develop behavioral change goals and action plans to attain the goals. Each participant will be educated and counseled to attain the desired lifestyles which will help them modulate their risk for cardiovascular disease. Every week, each participant will be called once to be reminded of their goals and action plans, and be motivated to consider adopting the healthy behaviors. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Are aged between 25 and 45 years 2. Are within the first (highest risk) tertile of participants with relatively higher values of 30-year CVD risk scores 3. Have a reliable mobile phone in their household, which they can use to receive personalized messages and phone calls in this study 4. Are from within and immediate surrounding areas of Ndirande township 1. Have any physical, visual, and hearing impairments that may limit their level of participation in physical exercise 2. Are pregnant or breastfeeding 3. Have any diagnosed opportunistic infection or are sick Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 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 31/08/2023 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Ghandi Blantyre 0000 Malawi
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 31/05/2023 University of Hull Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Cottingham Road Hull HU6 7RX Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Peak oxygen consumption baseline and end of intervention
Primary Outcome 30-year Cardiovascular disease risk score baseline and end of intervention
Primary Outcome cardiovascular health status score baseline and end of intervention
Primary Outcome Quality of life baseline and end of intervention
Secondary Outcome Biomarkers of inflammation and cardiac dysfunction, including NTproBNP, C-RP, HbA1C and fasting glucose baseline and end of intervention
Secondary Outcome Visceral Adiposity index score baseline and end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ndirande Health Centre Ndirande township Blantyre 0000 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Commonwealth Scholarship Commission Tavistock Square London WC1H 9HF United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alice Namanja Mahatma Ghandi Road Blantyre Malawi Individual
Secondary Sponsor Professor Sean Carroll Cottingham Road Hull HU6 7RX Malawi University
Secondary Sponsor Dr. James Hobkirk Cottingham Road Hull HU6 7RX Malawi University
Secondary Sponsor Professor Johnstone Kumwenda Mahatma Ghandi Road Blantyre Malawi University
COLLABORATORS
Name Street address City Postal code Country
Professor Mwapatsa Mipando Mahatma Ghandi Road Blantyre Malawi
Dr. Kondwani Katundu Mahatma Ghandi Road Blantyre Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alice Namanja anamanja@kuhes.ac.mw +265997759408 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre Malawi Lecturer at Kamuzu University of Health Sciences Malawi PhD student at the University of Hull England United Kingdom
Role Name Email Phone Street address
Public Enquiries Alice Namanja anamanja@kuhes.ac.mw +265997759408 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre Malawi Lecturer at Kamuzu University of Health Sciences Malawi PhD student at the University of Hull England United Kingdom
Role Name Email Phone Street address
Scientific Enquiries Alice Namanja anamanja@kuhes.ac.mw +265997759408 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre Malawi Lecturer at Kamuzu University of Health Sciences Malawi PhD student at the University of Hull England United Kingdom
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of results or a link to the published results, including the anonymized individual participant data will be shared at the completion of the study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol At the end of 12 months post initiation of participant recruitment Access to the data will be available to all researchers. The data will be deposited in the University of Hull data repository system. Any person who would want to have access shall email Prof. Sean Carroll, who will review the intention and grant access accordingly.
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