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.: PACTR202201482072564 Date of Approval: 21/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF 8-WEEKS CIRCUIT EXERCISE TRAINING ON CARDIOPULMONARY INDICES, HEALTH STATUS AND BODY COMPOSITION AMONG SUBGROUPS OF PEOPLE LIVING WITH HIV AT ABALAKIKI, EBONYI STATE, NIGERIA
Official scientific title THE EFFECTS OF 8-WEEK CIRCUIT EXERCISE TRAINING ON CARDIOPULMONARY INDICES, HEALTH STATUS, AND BODY COMPOSITION AMONG SUBGROUPS OF PEOPLE LIVING WITH HIV AT ABAKALIKI, NIGERIA
Brief summary describing the background and objectives of the trial People living with the human immune virus or acquired immune deficiency syndrome (HIV/AIDS) who are undergoing highly active antiretroviral therapy (HAART) are experiencing improved life expectancy and changes in symptom presentation. These symptomatic changes include altered body composition, which is seen in body fat redistribution, impaired cardiopulmonary function, and decreased health status. A common practice among healthy and other clinical populations to help modify these changes is some form of aerobic exercise, resistance exercise, or a combination of both. The main objective of this study is to determine the effect of 8 weeks of circuit exercise training on the cardiopulmonary indices, health status, and body composition of HIV-patient subgroups.
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 Supportive care
Anticipated trial start date 17/01/2022
Actual trial start date 24/01/2022
Anticipated date of last follow up 24/02/2022
Actual Last follow-up date 10/08/2022
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 90
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Circuitexercise Asymptomatic group Moderate intensity circuit exercise training three times per week (with at least 1 day of rest between sessions) and between 30- 60 minutes per session Eight weeks The training program consists of 10 types of resistance and aerobic exercise. Specifically, the resistance exercise program comprised of push-up, squat, crunches, side lunge, and superman exercise. The aerobic exercise program comprised of light jumping, running on the spot, foot-stamping, steps, jumping jack. Each exercise in the training program is performed for 60 sec, and the resting time was 20 seconds between stations and 3 min between sets. Each session will include a warm-up and cool-down period involving 10 min of low-intensity and light stretching activities. Each exercise in the training program was performed for 60 sec, and resting time was 20 seconds between stations and 3 min between sets. 30
Experimental Group Circuit exercise Symtomatic group Moderate Intensity(50%-70%) circuit exercise 3 times a week (with at least 1 day of rest between sessions) and between 30- 60 minutes per session. And as the week progresses and the fitness level of the participant increases, the exercise rest time and number of repetitions is adjusted Eight weeks Each session includes a warm-up and cool-down period involving 10 min of low-intensity and light stretching activities. The training program consists of 10 types of resistance and aerobic exercise. Specifically, the re¬sistance exercise program comprised of push-up, squat, crunches, side lunge, and superman exercise and an aerobic exercise program comprised of light jumping, running on the spot, foot-stamping, steps, jumping jack. Each exercise in the training program is performed for 60 sec, and resting time is 20 seconds between stations and 3 min between sets. 30
Control Group Control No exercise 8 weeks None 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Current use of ARV drugs. Age equal or older than 18 years. Availability to attend the study activities Pregnancy Active opportunistic infections. Age younger than 18 years. Contraindications to exercise testing and training (ACSM, 2010). Significant cognitive impairment or inability to follow instructions Involvement in a regular exercise program (defined as two or more structured exercise sessions weekly for more than, or equal to, six months prior to enrolment). 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 13/10/2021 Alex Ekwueme Federal University Teaching Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 1 Chidume Street, Behind State Prison Headquarters Abakaliki 480282 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiopulmonary outcomes include Blood pressure, Resting heart rate, oxygen saturation, maximum oxygen consumption, forced vital capacity FVC, forced expiratory volume in one second FEV1, FEV1/FVC ratio. Body Composition outcomes include BMI, Waist circumference, hip circumference, waist to hip ratio, body fat, visceral fat, and muscle mass. Health status At baseline and at 8 - weeks
Secondary Outcome None None
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital No 1 Chidume Street, Behind State Prisons Headquaters, PMB 102 Abakaliki 480282 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr John Davidson Okwudili Plot 6, Airport Hillview Avenue Thinkers Corner, Emene Enugu 400103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr John Davidson Okwudili Plot 6 Airport hillview avenue, thinkers corner, Emene Enugu 400103 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Davidson John davidsonokwudili@yahoo.com +2348032529550 Plot 6 airport Hillview Avenue, thinkers corner, Emene
City Postal code Country Position/Affiliation
Enugu 400231 Nigeria Principal Physiotherapist Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria and Adjunct lecturerer Department of physiotherapy Evangel University Akaeze Ebonyi State Nigera
Role Name Email Phone Street address
Public Enquiries Jeneviv John cynthia.john@unn.edu.ng +2348038781954 Plot 6, Airport hillview avenue, thinkers corner, Emene
City Postal code Country Position/Affiliation
Enugu 400231 Nigeria Lecturer. Department of Medical Rehabilitation Faculty of Health Sciences University of Nigeria Enugu
Role Name Email Phone Street address
Scientific Enquiries Davidson John davidsonokwudili@yahoo.com +2348032529550 Plot 6 Airport Hillview Avenue, Thinkers corner, Emene
City Postal code Country Position/Affiliation
Enugu 400231 Nigeria Principal physiotherapist Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria and Adjunct Lecturer Department of Physiotherapy Evangel University Akaeze Ebonyi State Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data to be shared include: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPDw ill be shared immediately following publication. No end date Anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available yet ( Link will be included when the article is published. 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