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.: PACTR201911846341825 Date of Approval: 06/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Exercises on balance impairment, gait disturbance, and quality of life of persons living with HIV-relate neuropathy.
Official scientific title Effect of Exercises on balance impairment, gait disturbance, and quality of life of persons living with HIV-relate Distal symmetrical poly-neuropathy.
Brief summary describing the background and objectives of the trial Individuals infected with human immune deficiency virus (HIV) often present clinically with distal symmetrical polyneuropathy (DSPN). This leads to poor balance and walking requiring physiotherapy interventions and physical rehabilitation. Physiotherapists facilitate the rehabilitation of individuals with disabilities and limitations of activities of daily living to improve their quality of life. Many modalities are available to physiotherapists but exercise programs for this population are limited. This study aim to explore the safety and effect of progressive resisted exercise (PRE) and aerobic exercise (AE) for balance impairment, gait disturbance, and quality of life for individuals presenting with HIV-related DSPN.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Rehabilitation
Anticipated trial start date 16/11/2019
Actual trial start date 30/11/2019
Anticipated date of last follow up 07/03/2020
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 150
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group quadraceps resistance exercises 3 times per week for 6weeks 30minutes The participants would undergo quadriceps resistance exercise using 60-70% of 1 repetition maximum 50
Experimental Group trademill aerobic exercise 3times per week 6weeks The participants would undergo aerobic exercise using treadmill with intensity of 60-70% of HRmax. 50
Control Group non exercise control group once in a week 6weeks The control group would attend HIV-talks, counseling, and video presentations once in a week. The HIV-talks will focused on the prevention and management of HIV, the relevance of exercises and physical activities and maintaining a healthy lifestyle for a good quality of life following HIV infection. They will be allowed to participate in exercise intervention when found useful. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria are: those on Antiretroviral (ARV) drugs for a minimum of 6 months and cluster of differentiation 4 (CD4+) counts of > 200 cells/mm3., walking without any assistive devices, a Subjective Periphery Neuropathy score of ≥ 7 which confirmed the presence of DSPN and having no contra-indications to engage in exercises and exercise programs The exclusion criteria are: those with central nervous dysfunction, hemiparesis, myelopathy, cerebellar ataxia, and surgical interventions within the last six months or were participating in other exercise programs Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 20/09/2019 Kano State Hospital management baord Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Post Office way kano 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Balance impairment, gait disturbance, and quality of life baseline, 3week, and 6weeks
Secondary Outcome muscle strength baseline, 3week, and 6weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist Hospital and Abdullahi wase specialist Hospital Kano Nigeria Old city road Kano kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Abdulsalam Mohammed Yakasai 1 katsina road kano, federal government secreteriat complex, kano state. Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kano state Hospital management Board Post office road kano 00234 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Sonill Mahraj Resevoir hills westvill campus Durban 4000 South Africa
Musa Sani Danazumi Nguru Yobe 00234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +2348060840806 1 katsina road
City Postal code Country Position/Affiliation
kano 00234 Nigeria Young researcher
Role Name Email Phone Street address
Public Enquiries ABDULLAHI MOHAMMED MAHMUD drabdul@gmail.com +2348054444447 post office road
City Postal code Country Position/Affiliation
kano 00234 Nigeria Head ethics committee
Role Name Email Phone Street address
Scientific Enquiries Musa Danazumi musadanazumi@gmail.com +2348131064717 rijiyar zaki
City Postal code Country Position/Affiliation
kano 00234 Nigeria supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The researcher is ready to share the outcome of the study when requested to do so. These include row data, results, clinical study report and so on. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol As soon as we are done with data analysis we can share informed consent but the data, interpretation, and clinical study report will be after publication. All the authors have the right to share the data or study report to any researcher irrespective of their qualifications.
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