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.: PACTR201707002173240 Date of Approval: 04/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Progressive Resisted and Aerobic Exercises in the rehabilitation of patients with HIV-related distal symmetrical polyneuropathy and health-r
Official scientific title Effect of Progressive Resisted and Aerobic Exercises in the rehabilitation of patients with HIV-related distal symmetrical polyneuropathy and health-related quality life in the era of HAART.
Brief summary describing the background and objectives of the trial Distal symmetrical poly-neuropathy (DSPN) has emerged as one of the major neurological complication associated with HIV/AIDS and antiretroviral therapy. People with DSPN commonly have problems with pain, altered gait and balance all which affect their quality of life. While therapeutic exercise have been reported to attenuate these impairments in other co-morbid conditions like diabetes mellitus but in HIV/AIDS there is no evidence available on DSPN in people living with HIV (PLWIH).The purpose of this study is to determine the effects of progressive resisted exercise (PRE) and aerobic exercise (AE) on patients with HIV/AIDS related distal symmetrical polyneuropathy and health related quality of life. The sample size of this study would comprise 102 Subjects diagnosed with HIV related DSPN sourced from four HIV centers in Kano Nigeria using purposive sampling technique, and would be randomized into three different groups. The experimental groups will undergo an intervention program of PRE and AE sessions of 30minutes for the lower limbs, three times per week over 12 weeks. The control group would be a non-exercising group. The data for this research would be collected and analyze using descriptive statistics (means± standard deviation, percentage and frequency) for demographic characteristics of the participants. The inferential statistics would be used to calculate if there are any significant changes in the dependent variables pre- post intervention. All statistical analyses would be performed at a probability level of 0.05.
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 Treatment: Other
Anticipated trial start date 09/04/2017
Actual trial start date 30/04/2017
Anticipated date of last follow up 20/08/2017
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
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 Computer generated randomization system of numbers 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 AEROBIC EXERCISE 3 TIMES/WEEK 30MINUTES ENDURANCE EXERCISE USING CYCLE ERGOMETER 34
Experimental Group Progressive resisted Group 3 times a week 30 minutes progressive resisted exercise using quadraceps bench 34
Control Group non-exercise control group once a week 30minutes Lectures by public health specialist 34 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants would be 18 to 50 years of age and both female and male who are HIV positive and on first line antiretroviral therapy for at least six months, CD4+counts of any level and ambulant participants with lower limb symmetrical neuropathy. Any subject presenting with history of central nervous system dysfunction, hemiparesis, amputation, foot ulcers, scoliosis, renal, mental, problem with communication, tuberculosis, dementia, myelopathy and/or cerebellar ataxia. Also subject with lower limb, spine or hip fracture in the last six weeks will be excluded in the study. Subject participating in any structured exercise or any sporting activities will be excluded 18 Year(s) 50 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 16/03/2015 BIOMEDICAL RESEARCH ETHIC COMMITEE
Ethics Committee Address
Street address City Postal code Country
WESTVILL CAMPUS GOVEN NBEKHI BUILDING DURBAN 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PAINS LEVEL PRE INTERVENTION 6WEEKS POST INTERVENTIO 12WEEKS POST INTERVENTION
Primary Outcome GAIT PRE-INTERVENTION 6WEEKS POST INTERVENTION 12WEEKS POST INTERVENTION
Primary Outcome BALANCE PRE INTERVENTION 6WEEKS POST INTERVENTION 12WEEKS POST INTERVENTION
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MOHAMMED ABDULLAHI WASE SPECIALISTS HOSPITL NASARAWA GRA KANO Nigeria
INFECTIOUS DISEAES HOSPITAL FRANCE ROAD KANO Nigeria
International Clinics and Hospital kano 2A/40Airport road/niger road kano kano 234 Nigeria
MURTALA MOHAMMED SPECIALIST HOSPITAL MAIN CITY KANO Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
COLLEGE OF HEALTH SCIENCE UNIVERSITY OD KWAZULU-NATAL RESEVOIR HILL DURBAN 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor COLLEGE OF HEALTH SCIENCE UNIVERSITY OD KWAZULU-NATAL RESEVOIR HILL DURBAN 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
KANO STATE SCHOOLARSHIP BOARD ABDULLAHI BAYERO ROAD KANO 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABDULSALAM YAKASAI abdulpeace1@gmail.com +2348060840806 HAT FIELD VARSITY DRIVE RESEVOIR HILL
City Postal code Country Position/Affiliation
DURBAN 4000 South Africa PhD STUDENT
Role Name Email Phone Street address
Public Enquiries ABDULLAHI AHMAD drabdul60@yahoo.com +2348054444447 France road
City Postal code Country Position/Affiliation
kano 234 Nigeria Head research ethics committee, kano state hospital management board
Role Name Email Phone Street address
Scientific Enquiries SONIL MAHARAJ ssmaharaj@ukzn.ac.za +27817088602 RESEVOIR HILL WESTVILL CAMPUS
City Postal code Country Position/Affiliation
DURBAN 4000 South Africa RESEARCH SUPERVISOR
REPORTING
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