- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03009149
Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait
Effects of Aerobic Exercise on CD4 Count,Viral Load,Selected Psycho-social Trait Among People Living With HIV/AIDS in Nekemte, Ethiopia
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Raná fáze 1
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
-
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: AEROBIC EXERCISE
The effects of 12 week aerobic exercise will record
|
Aerobic exercise will perform 3 days per week
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
CD4 count
Časové okno: 12 weeks
|
Amount of Cd4 will measure with in one ml blood sample
|
12 weeks
|
Effects of aerobic exercise on psycho-social
Časové okno: 12 weeks
|
psycho-social will measure by stander questioner called WHOQOL-briff
|
12 weeks
|
viral load change duo to aerobic exercise
Časové okno: 12 weeks
|
viral load will measured with in one milliliter of blood
|
12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Girma Mr Tilahun, MSc, phd Scholar
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- Stringer WW. HIV and aerobic exercise. Current recommendations. Sports Med. 1999 Dec;28(6):389-95. doi: 10.2165/00007256-199928060-00002.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- ERC0771/2016
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthNáborHIV | Testování HIV | HIV vazba na péči | Léčba HIVSpojené státy
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement a další spolupracovníciNeznámýHIV | Děti neinfikované HIV | Děti vystavené HIVKamerun
-
University of MinnesotaStaženoHIV infekce | HIV/AIDS | Hiv | AIDS | Problém AIDS/Hiv | AIDS a infekceSpojené státy
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationDokončenoPartnerské HIV testování | Poradenství pro pár HIV | Párová komunikace | Výskyt HIVKamerun, Dominikánská republika, Gruzie, Indie
-
CDC FoundationGilead SciencesNeznámýPreexpoziční profylaxe HIV | Chemoprofylaxe HIVSpojené státy
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... a další spolupracovníciNábor
-
Erasmus Medical CenterZatím nenabírámeHIV infekce | Hiv | HIV-1-infekce | HIV I infekceHolandsko
-
Hospital Clinic of BarcelonaDokončenoInhibitory integrázy, HIV; HIV PROTEASE INHIBŠpanělsko
-
University of WashingtonNational Institute of Mental Health (NIMH)NáborPrevence HIV | Preexpoziční profylaxe HIV | ImplementaceKeňa
-
University of Maryland, BaltimoreStaženoHiv | Transplantace ledvin | Zásobník HIV | CCR5Spojené státy
Klinické studie na Aerobic exercise
-
Professor Fernando Figueira Integral Medicine InstituteCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo...DokončenoDiabetes, gestačníBrazílie
-
NYU Langone HealthNew York UniversityDokončenoZávislost na alkoholu | Drogová závislost
-
Federal University of São PauloDokončenoArtritida, revmatoidníBrazílie
-
Fundació Sant Joan de DéuParc Sanitari Sant Joan de Déu; Solidaritat Sant Joan de Déu; FluidraNábor
-
Professor Fernando Figueira Integral Medicine InstituteConselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de...Dokončeno
-
New York State Psychiatric InstituteFeinstein Institute for Medical ResearchDokončeno
-
Riphah International UniversityDokončeno
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Dokončeno
-
New York State Psychiatric InstituteDokončeno
-
Region SkaneNeznámýChronické onemocnění ledvinŠvédsko