<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009149</url>
  </required_header>
  <id_info>
    <org_study_id>ERC0771/2016</org_study_id>
    <nct_id>NCT03009149</nct_id>
  </id_info>
  <brief_title>Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait</brief_title>
  <official_title>Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait Among People Living With HIV/AIDS in Nekemte, Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mekelle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mekelle University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      H1 - Aerobic exercise will expect to experience significant increase on CD4 counts , reduced&#xD;
      viral load , improve psycho-social well being among people living with HIV /AIDS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title - Effects of Aerobic Exercise on CD4(cluster of differentiation 4) count , Viral load&#xD;
      and Selected Psycho-social Traits Among People Living with HIV/AIDS in Nekemte, Ethiopia&#xD;
&#xD;
      Human being have been challenged with different diseases from time to time. The cause of this&#xD;
      diseases are virus , bacteria , fungi and etc. A diseases caused by virus , the Acquired&#xD;
      Immune Deficiency Syndrome (AIDS) is very challenging to this century . By the end of 2008,&#xD;
      UNAIDS/ world health organization (WHO) estimated that globally, a total of 33.4 million&#xD;
      people were living with HIV, where by 31.3 million were adults. In sub-Saharan Africa, 22.4&#xD;
      million people were living with HIV in 2008 . Of these on 15.8 million were under anti-retro&#xD;
      viral therapy (ART) to Jun, 2015 and 1.2 mill people died with AIDS related illnesses till&#xD;
      end of the 2014 .&#xD;
&#xD;
      Aerobic fitness can improve the health of people living with many diseases, including HIV,&#xD;
      and prevents muscle wasting . Exercise benefits may be include cytokine regulation, as is&#xD;
      suggested in studies of autoimmune diseases such as multiple sclerosis. Aerobic exercise is&#xD;
      one type of rehabilitation strategy that may be used to address disability, such as decreased&#xD;
      strength and cardiovascular fitness for persons living with HIV . Exercise may also important&#xD;
      to people living with virus because of its link to disease prevention and health promotion.&#xD;
      Furthermore, aerobic exercise is creditable of attention because of its connection to body&#xD;
      image, which has been shown to be important in certain populations affected by HIV.&#xD;
&#xD;
      This study will conduct in Nekemete town found in east Wollega zone , Oromia regional state.&#xD;
      It will be a randomized controlled trial experimental research. The study design will&#xD;
      pre-post of experimental clinical trial. Experimental trial will be with intervention of&#xD;
      aerobic exercise among people living with HIV/AIDS under ART. The number of sample size is&#xD;
      58. Data analyses will perform with statical analysis for social science (SPSS) version 20.&#xD;
      Descriptive data (means, standard deviations (SD) and standard error of the mean (SE),&#xD;
      frequency, cross tabulation, charts) will calculate for all variables. The gender difference,&#xD;
      viral load, CD4 count, data will analyze using simple t-test and analysis of co-variance&#xD;
      (ANCOVA). The level of significance for all analyses will be set at P &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD4 count</measure>
    <time_frame>12 weeks</time_frame>
    <description>Amount of Cd4 will measure with in one ml blood sample</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of aerobic exercise on psycho-social</measure>
    <time_frame>12 weeks</time_frame>
    <description>psycho-social will measure by stander questioner called WHOQOL-briff</description>
  </primary_outcome>
  <primary_outcome>
    <measure>viral load change duo to aerobic exercise</measure>
    <time_frame>12 weeks</time_frame>
    <description>viral load will measured with in one milliliter of blood</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>AEROBIC EXERCISE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The effects of 12 week aerobic exercise will record</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>Aerobic exercise will perform 3 days per week</description>
    <arm_group_label>AEROBIC EXERCISE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both female and male under ART&#xD;
&#xD;
          2. The distribution of HIV prevalence also varies by age peaking in the 30-40 years age&#xD;
             group compared to the other (FDRE,2014) . Because of this the 30-40 will be selected.&#xD;
&#xD;
          3. Participants who have been on first line antiretroviral therapy will be selected.&#xD;
&#xD;
          4. Willing and able to give an informed and agree consent&#xD;
&#xD;
          5. Free of HIV/AIDS related chronic infections that do not allowed aerobic exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants with a history of central nervous system dysfunction, hemiparesis&#xD;
             (paralysis of one side of the body).&#xD;
&#xD;
          2. Diabetic patients&#xD;
&#xD;
          3. Participant on either as prophylaxis such as the use of antibiotics to prevent&#xD;
             infections or as part of (tuberculosis)TB treatment&#xD;
&#xD;
          4. Pregnant and lactating women&#xD;
&#xD;
          5. Free of risk factors those are series cardiac problem&#xD;
&#xD;
          6. Participant who remain in study area throughout the period of study&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Girma Mr Tilahun, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>phd Scholar</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>16540826</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10190777</PMID>
  </reference>
  <reference>
    <citation>Stringer WW. HIV and aerobic exercise. Current recommendations. Sports Med. 1999 Dec;28(6):389-95. doi: 10.2165/00007256-199928060-00002.</citation>
    <PMID>10623982</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11371683</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21180864</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15296660</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10416558</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20687068</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15846623</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12076422</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mekelle University</investigator_affiliation>
    <investigator_full_name>Girma Tilahun</investigator_full_name>
    <investigator_title>PHD scholar</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009149
org study id: ERC0771/2016
nct id: NCT03009149
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: CD4 count
time frame: 12 weeks
description: Amount of Cd4 will measure with in one ml blood sample
measure: Effects of aerobic exercise on psycho-social
time frame: 12 weeks
description: psycho-social will measure by stander questioner called WHOQOL-briff
measure: viral load change duo to aerobic exercise
time frame: 12 weeks
description: viral load will measured with in one milliliter of blood
arm group label: AEROBIC EXERCISE
arm group type: Experimental
description: The effects of 12 week aerobic exercise will record
intervention type: Other
intervention name: Aerobic exercise
description: Aerobic exercise will perform 3 days per week
arm group label: AEROBIC EXERCISE
criteria: 
gender: All
minimum age: 30 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Girma Mr Tilahun, MSc
role: Principal Investigator
affiliation: phd Scholar
citation: 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.
PMID: 16540826
citation: 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.
PMID: 10190777
citation: Stringer WW. HIV and aerobic exercise. Current recommendations. Sports Med. 1999 Dec;28(6):389-95. doi: 10.2165/00007256-199928060-00002.
PMID: 10623982
citation: 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.
PMID: 11371683
citation: 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.
PMID: 21180864
citation: 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.
PMID: 15296660
citation: 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.
PMID: 10416558
citation: 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.
PMID: 20687068
citation: 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.
PMID: 15846623
citation: 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.
PMID: 12076422
responsible party type: Principal Investigator
investigator affiliation: Mekelle University
investigator full name: Girma Tilahun
investigator title: PHD scholar