NCT03009149

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P50-P75 for early_phase_1 hiv

Timeline
Completed

Started Nov 2016

Shorter than P25 for early_phase_1 hiv

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

December 8, 2016

Last Update Submit

December 30, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • CD4 count

    Amount of Cd4 will measure with in one ml blood sample

    12 weeks

  • Effects of aerobic exercise on psycho-social

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

    12 weeks

  • viral load change duo to aerobic exercise

    viral load will measured with in one milliliter of blood

    12 weeks

Study Arms (1)

AEROBIC EXERCISE

EXPERIMENTAL

The effects of 12 week aerobic exercise will record

Other: Aerobic exercise

Interventions

Aerobic exercise will perform 3 days per week

AEROBIC EXERCISE

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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: 16540826BACKGROUND
  • 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: 10190777BACKGROUND
  • Stringer WW. HIV and aerobic exercise. Current recommendations. Sports Med. 1999 Dec;28(6):389-95. doi: 10.2165/00007256-199928060-00002.

    PMID: 10623982BACKGROUND
  • 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: 11371683BACKGROUND
  • 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: 21180864BACKGROUND
  • 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: 15296660BACKGROUND
  • 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: 10416558BACKGROUND
  • 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: 20687068BACKGROUND
  • 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: 15846623BACKGROUND
  • 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: 12076422BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Girma Mr Tilahun, MSc

    phd Scholar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD scholar

Study Record Dates

First Submitted

December 8, 2016

First Posted

January 4, 2017

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 4, 2017

Record last verified: 2016-12