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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201803003147805 |
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Date of registration:
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26/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of exercise on HIV - Associated Peripheral neuropathy
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Scientific title:
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The effect of physiotherapeutic exercises on peripheral neuropathy among PLHIV on ART in Kigali - Rwanda |
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Date of first enrolment:
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05/03/2012 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3147 |
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Study type:
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Interventional |
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Study design:
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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
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Phase:
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Not Applicable
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Aimee
Stewart |
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Address:
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Physiotherapy Department, University of the Witwatersrand, 7 York Road, Park Town
Johannesburg
South Africa |
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Telephone:
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0027 21 0117173718 |
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Email:
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aimee.stewart@wits.ac.za |
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Affiliation:
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University of the Witwatersrand |
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Name:
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David
Tumusiime |
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Address:
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University of Rwanda; Remera Campus
3286
Kigali
Rwanda |
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Telephone:
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+250 788749398 |
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Email:
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dktumusiime@gmail.com |
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Affiliation:
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Senior Lecturer; University of Rwanda |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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.
Age minimum:
18 Year(s)
Age maximum:
59 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
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Peripheral Neuropathy
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HIV/AIDS
Peripheral Neuropathy
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Intervention(s)
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Exercise intervention
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Routine health Care at ART clinic
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Primary Outcome(s)
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Change in Peripheral neuropathy symptoms and signs
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Secondary Outcome(s)
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Functional ability of lower extremity
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Source(s) of Monetary Support
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University of Rwanda, College of Medicine and Health Sciences (former Kigali Health Institute
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Ethics review
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Status: Approved
Approval date: 16/09/2008
Contact:
Human Research Ethics Committee , University of the Witwatersrand
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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