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HIVEarly Phase 1NCT03009149

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

A Early Phase 1 study testing Aerobic exercise in people with HIV, run by Mekelle University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 30 to 40 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
No sites listed yet
Study dates
Nov 2016to Feb 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Both female and male under ART
  • 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.
  • Participants who have been on first line antiretroviral therapy will be selected.
  • Willing and able to give an informed and agree consent
  • Free of HIV/AIDS related chronic infections that do not allowed aerobic exercise

Who cannot join

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

About this study

Official title: Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait Among People Living With HIV/AIDS in Nekemte, Ethiopia

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.

Conditions
HIV
Being tested
Aerobic exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03009149
Study groupRoleWhat they receive
AEROBIC EXERCISEExperimentalThe effects of 12 week aerobic exercise will record
Receives: Other: Aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD4 count

    Amount of Cd4 will measure with in one ml blood sample

    Measured: 12 weeks

  2. Effects of aerobic exercise on psycho-social

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

    Measured: 12 weeks

  3. viral load change duo to aerobic exercise

    viral load will measured with in one milliliter of blood

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study startNov 2016
  3. Primary completionJan 2017 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009149
Sponsor's protocol ID
ERC0771/2016
Status last verified
Dec 2016
First submitted
8 Dec 2016
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Aerobic exercise in people with HIV, run by Mekelle University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 count (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03009149, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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