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.: PACTR201308000588258 Date of Approval: 11/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of aerobic exercise programme on cardiovascular parameters and CD4 count of subjects living with HIV/AIDS: A randomized controlled trial
Official scientific title Exercise and CD4 count in HIV/AIDS
Brief summary describing the background and objectives of the trial The primary objective of this study was to investigate the effect of 8 weeks aerobic exercise training on CD4 count of subjects living with HIV/AIDS Methods: Age matched randomized controlled trial design was used; subjects living with HIV/AIDS receiving treatment in President¿s Emergency Plan For AIDS Relief (PEPFAR) at the HIV clinic of the University of Nigeria Teaching Hospital, Ituku Ozalla. Enugu. Thirty subjects (N=30) with HIV/AIDS (mean CD4 count range of 504.13±231.61 cells/mm3) were age matched and randomized to two groups: exercise (n= 15) and control (n=15) groups. The exercise group involved in an 8 weeks moderate intensity continuous exercise training (60%--79% HR max) of between 45 and 60 min, 3 times per week, while the controls group remain sedentary. SBP, DBP, VO2 max and CD4 count were assessed. Analysis of co-variance and Pearson correlation tests were used in data analysis Results: Findings of the study revealed significant effect of moderate intensity continuous exercise training program on, SBP, DBP, VO2max and CD4 count at p< 0.05. Changes in VO2 max significantly correlated with changes in CD4 count (r= .528) at p< 0.05. Conclusion: It was concluded that moderate intensity aerobic exercise programme is effective adjunct therapy and in boosting the CD4 count in subjects living with HIV/AIDS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 07/08/2012
Actual trial start date 07/08/2012
Anticipated date of last follow up 24/10/2012
Actual Last follow-up date 24/10/2012
Anticipated target sample size (number of participants) 33
Actual target sample size (number of participants) 30
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 Stratification (Age matched) Double blind (External investigator ) Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercdise group 3times/week for 8weeks 60minutes for 8weeks 15
Control Group Control group 8weeks sedentary 8weeks 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only those who volunteered to participate in the study were recruited. Male and females subjects between the age range of 18 and 64 years with the diagnosis of HIV/AIDS infection participated in the study. Only those receiving treatment in UNTH were also recruited for the study Smokers, alcoholic, diabetic, other cardiac, renal, respiratory disease patients were excluded. Those involved in vigorous physical activities and above averagely physically fit (VO2max >27 & >33 ml/kg.min for over 60 & 50 years old respectively) were also excluded. 18 Year(s) 64 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 12/06/2012 Ethics Committee of the University of Nigeria Teaching Hospital, Enugu, Nigeria
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teachinh Hospital, Enugu, Nigeria Enugu Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CD4 count; VO2max 8weeks interval 8weeks interval
Secondary Outcome Systolic blood pressure (SBP); Diastolic blood pressure (DBP) 8weeks interval 8weeks interval
Primary Outcome CD4 count; VO2max 8weeks interval 8weeks interval
Secondary Outcome Systolic blood pressure (SBP); Diastolic blood pressure (DBP) 8weeks interval 8weeks interval
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital University of Nigeria Teaching Hospital Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors University of Nigeria, Enugu Campus Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Nigeria, Enugu Campus University of Nigeria, Enugu Campus Enugu Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Lamina Sikiru University of Nigeria, Enugu Campus Enugu Nigeria
Charles Ezema University of Nigeria, Enugu Campus Enugu Nigeria
Ugwulebor Josephine Ugochi University of Nigeria, Enugu Campus Enugu Nigeria
Ezugwu UA University of Nigeria Teaching Hospital Enugu Nigeria
Amaeze AA University of Nigeria Teaching Hospital Enugu Nigeria
Nwankwo MJ Nnamdi Azikiwe University Awka Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charle Ezema gloryzemas@yahoo.com +2348037494795 University of Nigeria, Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria University of Nigeria
Role Name Email Phone Street address
Public Enquiries Austin Amaeze aamaeze@yahoo.com +2348033160350 University of Nigeria Teaching Hospital
City Postal code Country Position/Affiliation
Enugu Nigeria
Role Name Email Phone Street address
Scientific Enquiries Sikiru Lamina siklam_86@yahoo.co.uk +2348035319469 University of Nigeria, Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria University of Nigeria, Enugu Campus
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information