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.: PACTR201803003147805 Date of Approval: 26/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of exercise on HIV - Associated Peripheral neuropathy
Official scientific title The effect of physiotherapeutic exercises on peripheral neuropathy among PLHIV on ART in Kigali - Rwanda
Brief summary describing the background and objectives of the trial HIV-associated peripheral neuropathy (PN) is one of the most challenging conditions in the health care of people living with HIV (PLHIV). The most common PN is distal sensory polyneuropathy (DSP) often assessed and diagnosed with the Brief Peripheral Neuropathy Screen (BPNS) [1]. Both pharmacological and non-pharmacological modalities are recommended in the management of PN [2], but management has been mostly symptomatic and pharmacological which may not have an effect on the neuromuscular function that is affected by the PN. There is insufficient literature on how non- pharmacological modalities, such as physical exercise in particular are applied and effective in the management of HIV-associated PN. The available literature is mostly on the effects of exercise on PN in other health conditions such as diabetes [3] where strengthening and balance training exercises incorporated into aerobic exercise programmes have been shown to be beneficial for people with PN related diabetes [4-6]. The beneficial effects of exercise in other conditions in PLHIV may be similar for those with PN. The existing evidence shows that exercises are safe and affordable in PLHIV [7-9]. However, there is a paucity of reported aerobic exercise interventions specifically for PLHIV with PN, and how effective the exercises are in managing PN in PLHIV on ART. This is particularly so in Sub Saharan Africa and specifically in Rwanda. Thus, it became important to test the effectiveness of non- pharmacological management; such as physiotherapeutic exercises using a Randomised Controlled Trial (RCT), to determine the effects of exercises on PN among PLHIV on ART given that this is a simple inexpensive intervention that could be rolled out to PLHIV. Health care professionals need treatment options for PLHIV with established PN, irrespective of the aetiology of the PN. Purpose: The study established the effects of physiotherapeutic exercise (PTEx) on PN among PLHIV on ART in Rwanda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Peripheral Neuropathy
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 05/03/2012
Actual trial start date 05/03/2012
Anticipated date of last follow up 08/06/2012
Actual Last follow-up date 14/09/2012
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised 120 participants were randomised into 60 in the experimental and 60 in the control group, using computer generated random numbers. Concealed allocation to groups was assured by an independent research assistant placing the numbers into opaque sealed envelopes which were then given to eligible participants by a second research assistant Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercise intervention 45-60minutes/session for 3 times/week for 12 weeks 12 weeks Physiotherapy - led exercises were given to experimental group in a form of aerobic exercise 60
Control Group Routine health Care at ART clinic Routine health care N/A N/A 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Included all people living with HIV on ART from the selected public outpatient ART clinics in Rwanda, aged 18 and above; both females and males, with no active opportunistic infection such as TB or others. People living with HIV on ART with known disorders of the central nervous system, PLHIV with a known history of diabetes, Vitamin B12 deficiency, TB, renal failure, hypothyroidism and other pathologies that may be associated with neuropathy, any clinical history that would be an exercise contraindication, unwilling to participate in the PTExs and the rest of the follow up programme, very weak patients who could not walk without support, other neuromusculoskeletal impairments such as, musculoskeletal deformity, amputation, scoliosis, and inability to actively and functionally move ankle and knee joints, lower extremity arthritis, and central neuropathies like hemiparesis and central paralyses. 18 Year(s) 59 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 16/09/2008 Human Research Ethics Committee , University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Senate House, 4th Floor, University of the Witwatersrand, 7th York Road, Park Town. Johannesburg South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in Peripheral neuropathy symptoms and signs at start (Baseline; 0 week) and at the end of intervention (enplane; 12 weeks)
Secondary Outcome Functional ability of lower extremity Measured at the start (baseline; 0 week) and at the end (end line; 12 weeks) of the exercise intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Rwanda, College of Medicine and Health Sciences (Former Kigali Health Institute) University of Rwanda, College of Medicine and Health Sciences Kigali 3286 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Rwanda, College of Medicine and Health Sciences (former Kigali Health Institute Av Paul IV, KIGALI KIGALI 3286 Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor None N/A N/A Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Aimee Department of Physiotherapy, School of therapeutic Sciences, University of Witwatersrand Johannesburg South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Tumusiime dktumusiime@gmail.com +250 788749398 University of Rwanda; Remera Campus
City Postal code Country Position/Affiliation
Kigali 3286 Rwanda Senior Lecturer; University of Rwanda
Role Name Email Phone Street address
Public Enquiries David Tumusiime dktumusiime@gmail.com +250 788749398 University of Rwanda; Remera Campus
City Postal code Country Position/Affiliation
Kigali 3286 Rwanda Senior Lecturer; University of Rwanda
Role Name Email Phone Street address
Scientific Enquiries Aimee Stewart aimee.stewart@wits.ac.za 0027 21 0117173718 Physiotherapy Department, University of the Witwatersrand, 7 York Road, Park Town
City Postal code Country Position/Affiliation
Johannesburg South Africa University of the Witwatersrand
REPORTING
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