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.: PACTR201904606647880 Date of Approval: 12/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Rebound Exercises or Combined Training on Depression, Anxiety, and other Indicators of Psychological Distress and Quality of Life in Persons Living with HIV
Official scientific title Influence of Rebound Exercises or Combined Training on Depression, Anxiety, and other Indicators of Psychological Distress and Quality of Life in Persons Living with HIV
Brief summary describing the background and objectives of the trial Mental illness is highly prevalent among people living with HIV. Poor mental health is linked to HIV disease progression, making the treatment of mental illness alongside HIV essential. .The main aim of this study is to investigate the effect of rebound exercises and combined training on the mental health of PLWHIV
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Rehabilitation
Anticipated trial start date 01/03/2019
Actual trial start date 08/03/2019
Anticipated date of last follow up 17/05/2019
Actual Last follow-up date 24/05/2019
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 60
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rebounds exercise group 30minutes 3times per week 12weeks The exercise will involve bouncing on the center portion of a mini trampoline (2013 Portable Model Half-Fold Cellerciser) with feet slightly apart and knees in full extension. The participants will receive routine medication and same Health magazine will be given to each participant which contained information regarding diet, and how to identify, minimize, or avoid complications of HIV-infection. 20
Experimental Group Combined exercise group 3times per week 12weeks The stations for combined training include 2 stations—1 and 2. Station 1 is the progressive resisted exercise (PRE) using quadriceps bench. The PRE program will engage the participants in the bilateral strengthening of the quadriceps, hamstrings, tibialis anterior and gastrocnemius muscles. Whereas station 2 is the aerobic exercise with the bicycle ergometer. The participants will receive routine medication and same Health magazine will be given to each participant which contained information regarding diet, and how to identify, minimize, or avoid complications of HIV-infection. 20
Control Group The nonexercise Control group 3times per week 12weeks Participants in the control group will receive routine medication as prescribed by the attending physicians at the HIV clinic and will be monitored. After 12weeks of routine care, the participants will be enrolled into either the rebound exercise or combined exercise group. The control group participants will receive routine medication and health magazines to read, whereas the exercise groups will be engaged in the exercise programs. The same Health magazine will be given to each participant of the three groups which contained information regarding diet, and how to identify, minimize, or avoid complications of HIV-infection. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants will be considered eligible if they have a CD4 count of equals to or greater than 200 cells per cubic millimeter. They will be recruited consecutively as they are available through the HIV outpatient clinic of the hospital by a member of the research team. Only participants with psychiatric disorders will be included in the study. The participants must be aged between 18and 55 years. Patients will be excluded from the study if they are involved in sporting activities or participating in other research that involved exercise intervention. Moreover, individuals with hypertension, coronary artery disease, or myocardial infarction; or who have had cardiac or abdominal surgery within the previous 6 months; or who have a history of fractures of the spine, hip, knee, or ankle joints, as well as those with lower limb weakness and deformities with a loss of protective sensation in the feet will be excluded. Similarly, pregnancy or lactation, and the presence of retinopathy or nephropathy will make a patient ineligible. Finally, subjects who do not consent to participate will be excluded from the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 01/03/2019 Kano State Hospital management Board ethical commutee
Ethics Committee Address
Street address City Postal code Country
Post office road kano. kano 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Psychological distress, symptoms depression, symptoms anxiety, quality of life. Pre-test, 6weeks,and 12weeks.
Secondary Outcome Heart rate, Blood pressure, Rate pressure product, pain. Pre-test, 6weeks,and 12weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed specilaist Hospital Kano kano old city road. Kano 00234 Nigeria
Mohammed Abdullahi Wase Specialist Hospital kano Hospital road Kano 00234 Nigeria
Infectious Dieases Hospital France road Kano 00234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ABDULSALAM MOHAMMED YAKASAI RESERVOIR HILLS DURBAN 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNIVERSITY OF KWAZULU NATAL RESERVOUR HILLS WESTVILL CAMPUS DURBAN 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. Sonill S. Maharaj Resevoir hill Durban 4000 South Africa
Dr. Abdullahi Ahmad Post office road Kano 00234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dr. Sonill MAHARAJ ssmaharaj@ukzn.ac.za +27834611413 Reservoir hill Versity Drive
City Postal code Country Position/Affiliation
DURBAN 4000 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries ABDULLAHI Ahmed drabdul60@yahoo.com +2348054444447 Post office road
City Postal code Country Position/Affiliation
Kano 00234 Nigeria Public enqueery
Role Name Email Phone Street address
Principal Investigator ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +2348060840806 Reservoir hill Versity Drive
City Postal code Country Position/Affiliation
DURBAN 4000 Nigeria POSTDOCTORAL FELLOW
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I'm ready to share the summary of the outcome of the study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan I shall share what I mentioned above as soon as we are done with data analysis and report (12weeks) and it will be available for the period of 5years. The result of the outcomes will be available for everyone but the data collected in this study will be given to professionals on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none 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