CClinicalTrials.gg
Status unknownNCT03009149Updated Jan 4, 2017

Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait

An Early Phase 1 interventional study of Aerobic exercise in HIV, sponsored by Mekelle University. Status unknown. Open to participants aged 30 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Mekelle University · Early Phase 1, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
30 Years to 40 Years
Sex
All
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Study summary

H1 - Aerobic exercise will expect to experience significant increase on CD4 counts , reduced viral load , improve psycho-social well being among people living with HIV /AIDS.

Read the detailed description

Title - Effects of Aerobic Exercise on CD4(cluster of differentiation 4) count , Viral load and Selected Psycho-social Traits Among People Living with HIV/AIDS in Nekemte, Ethiopia

Human being have been challenged with different diseases from time to time. The cause of this diseases are virus , bacteria , fungi and etc. A diseases caused by virus , the Acquired Immune Deficiency Syndrome (AIDS) is very challenging to this century . By the end of 2008, UNAIDS/ world health organization (WHO) estimated that globally, a total of 33.4 million people were living with HIV, where by 31.3 million were adults. In sub-Saharan Africa, 22.4 million people were living with HIV in 2008 . Of these on 15.8 million were under anti-retro viral therapy (ART) to Jun, 2015 and 1.2 mill people died with AIDS related illnesses till end of the 2014 .

Aerobic fitness can improve the health of people living with many diseases, including HIV, and prevents muscle wasting . Exercise benefits may be include cytokine regulation, as is suggested in studies of autoimmune diseases such as multiple sclerosis. Aerobic exercise is one type of rehabilitation strategy that may be used to address disability, such as decreased strength and cardiovascular fitness for persons living with HIV . Exercise may also important to people living with virus because of its link to disease prevention and health promotion. Furthermore, aerobic exercise is creditable of attention because of its connection to body image, which has been shown to be important in certain populations affected by HIV.

This study will conduct in Nekemete town found in east Wollega zone , Oromia regional state. It will be a randomized controlled trial experimental research. The study design will pre-post of experimental clinical trial. Experimental trial will be with intervention of aerobic exercise among people living with HIV/AIDS under ART. The number of sample size is 58. Data analyses will perform with statical analysis for social science (SPSS) version 20. Descriptive data (means, standard deviations (SD) and standard error of the mean (SE), frequency, cross tabulation, charts) will calculate for all variables. The gender difference, viral load, CD4 count, data will analyze using simple t-test and analysis of co-variance (ANCOVA). The level of significance for all analyses will be set at P \< 0.05.

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Conditions studied

  • HIV
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In context

Lead sponsor

Mekelle University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Both female and male under ART
  2. The distribution of HIV prevalence also varies by age peaking in the 30-40 years age group compared to the other (FDRE,2014) . Because of this the 30-40 will be selected.
  3. Participants who have been on first line antiretroviral therapy will be selected.
  4. Willing and able to give an informed and agree consent
  5. Free of HIV/AIDS related chronic infections that do not allowed aerobic exercise

Exclusion criteria

Exclusion Criteria:

  1. Participants with a history of central nervous system dysfunction, hemiparesis (paralysis of one side of the body).
  2. Diabetic patients
  3. Participant on either as prophylaxis such as the use of antibiotics to prevent infections or as part of (tuberculosis)TB treatment
  4. Pregnant and lactating women
  5. Free of risk factors those are series cardiac problem
  6. Participant who remain in study area throughout the period of study

    -

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Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    AEROBIC EXERCISE

    The effects of 12 week aerobic exercise will record

    Other: Aerobic exercise

Interventions

  • OtherAerobic exercise

    Aerobic exercise will perform 3 days per week

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What researchers measure

Primary outcomes

  1. CD4 count

    Amount of Cd4 will measure with in one ml blood sample

    Time frame: 12 weeks

  2. Effects of aerobic exercise on psycho-social

    psycho-social will measure by stander questioner called WHOQOL-briff

    Time frame: 12 weeks

  3. viral load change duo to aerobic exercise

    viral load will measured with in one milliliter of blood

    Time frame: 12 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Terry L, Sprinz E, Stein R, Medeiros NB, Oliveira J, Ribeiro JP. Exercise training in HIV-1-infected individuals with dyslipidemia and lipodystrophy. Med Sci Sports Exerc. 2006 Mar;38(3):411-7. doi: 10.1249/01.mss.0000191347.73848.80. PubMed 16540826 ↗
  • Terry L, Sprinz E, Ribeiro JP. Moderate and high intensity exercise training in HIV-1 seropositive individuals: a randomized trial. Int J Sports Med. 1999 Feb;20(2):142-6. doi: 10.1055/s-2007-971108. PubMed 10190777 ↗
  • Stringer WW. HIV and aerobic exercise. Current recommendations. Sports Med. 1999 Dec;28(6):389-95. doi: 10.2165/00007256-199928060-00002. PubMed 10623982 ↗
  • Smith BA, Neidig JL, Nickel JT, Mitchell GL, Para MF, Fass RJ. Aerobic exercise: effects on parameters related to fatigue, dyspnea, weight and body composition in HIV-infected adults. AIDS. 2001 Apr 13;15(6):693-701. doi: 10.1097/00002030-200104130-00004. PubMed 11371683 ↗
  • Gomes RD, Borges JP, Lima DB, Farinatti PT. Effects of physical exercise in the perception of life satisfaction and immunological function in HIV-infected patients: Non-randomized clinical trial. Rev Bras Fisioter. 2010 Sep-Oct;14(5):390-5. English, Portuguese. PubMed 21180864 ↗
  • Ramirez-Marrero FA, Smith BA, Melendez-Brau N, Santana-Bagur JL. Physical and leisure activity, body composition, and life satisfaction in HIV-positive Hispanics in Puerto Rico. J Assoc Nurses AIDS Care. 2004 Jul-Aug;15(4):68-77. doi: 10.1177/1055329003261966. PubMed 15296660 ↗
  • Perna FM, LaPerriere A, Klimas N, Ironson G, Perry A, Pavone J, Goldstein A, Majors P, Makemson D, Talutto C, Schneiderman N, Fletcher MA, Meijer OG, Koppes L. Cardiopulmonary and CD4 cell changes in response to exercise training in early symptomatic HIV infection. Med Sci Sports Exerc. 1999 Jul;31(7):973-9. doi: 10.1097/00005768-199907000-00009. PubMed 10416558 ↗
  • O'Brien K, Nixon S, Tynan AM, Glazier R. Aerobic exercise interventions for adults living with HIV/AIDS. Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD001796. doi: 10.1002/14651858.CD001796.pub3. PubMed 20687068 ↗
  • Nixon S, O'Brien K, Glazier RH, Tynan AM. Aerobic exercise interventions for adults living with HIV/AIDS. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001796. doi: 10.1002/14651858.CD001796.pub2. PubMed 15846623 ↗
  • Nixon S, O'Brien K, Glazier RH, Tynan AM. Aerobic exercise interventions for adults living with HIV/AIDS. Cochrane Database Syst Rev. 2002;(2):CD001796. doi: 10.1002/14651858.CD001796. PubMed 12076422 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03009149
Lead sponsor
Mekelle University
Responsible party
Girma Tilahun (PHD scholar, Mekelle University) — Principal investigator
First posted
Jan 4, 2017
Start date
Nov 2016
Primary completion
Jan 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Jan 4, 2017

Study contacts

Girma Mr Tilahun, MSc
principal investigator · phd Scholar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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