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Feasibility of Telerehabilitation in HIV-patients

2. november 2017 opdateret af: Caty, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients

The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).

HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years or older
  • under HAART treatment
  • native French speaker

Exclusion Criteria:

  • AIDS diagnosis
  • physical and/or psychiatric impairments that seriously impaired physical activity
  • pregnant
  • Unstable (defined by any modification of health outcomes during the last 6 months).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Sædvanlig pleje
Eksperimentel: Endurance and Resistance Training Exercise
Adfærdsmæssigt: Endurance ad Resistance Training Exercise
Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: At study completion (after 6 weeks)
Number of eligible participants who enrolled in the program out of the number were recruited
At study completion (after 6 weeks)
Retention rate
Tidsramme: At study completion (after 6 weeks)
Percentage of patients lost to follow-up
At study completion (after 6 weeks)
Adverse events
Tidsramme: At study completion (after 6 weeks)
Percentage of patients who experienced one or more adverse events
At study completion (after 6 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: Assessments at baseline and at 6 weeks
Weight (kg) is measured by using a bioelectrical impedance analysis
Assessments at baseline and at 6 weeks
Lean body mass
Tidsramme: Assessments at baseline and at 6 weeks
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
Assessments at baseline and at 6 weeks
Fat body mass
Tidsramme: Assessments at baseline and at 6 weeks
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
Assessments at baseline and at 6 weeks
C-reactive protein
Tidsramme: Assessments at baseline and at 12 weeks
C-reactive protein is measured by a blood test
Assessments at baseline and at 12 weeks
D-dimer
Tidsramme: Assessments at baseline and at 12 weeks
D-dimer is measured by a blood test
Assessments at baseline and at 12 weeks
CD4+ T cell counts
Tidsramme: Assessments at baseline and at 12 weeks
CD4+ T cell counts is measured by a blood test
Assessments at baseline and at 12 weeks
Viral load
Tidsramme: Assessments at baseline and at 12 weeks
Viral load is measured by a blood test
Assessments at baseline and at 12 weeks
Functional exercise capacity
Tidsramme: Assessments at baseline and at 6 weeks
Functional exercise capacity is measured by a 6-minute walk test
Assessments at baseline and at 6 weeks
Flexibility
Tidsramme: Assessments at baseline and at 6 weeks
Flexibility is measured by Toe touch test and sit and reach test
Assessments at baseline and at 6 weeks
Lower body muscular strength
Tidsramme: Assessments at baseline and at 6 weeks
Lower body muscular strength is measured by 30-s chair-stand test
Assessments at baseline and at 6 weeks
Upper limb strength
Tidsramme: Assessments at baseline and at 6 weeks
Upper limb strength is measured by hand grip strength tool
Assessments at baseline and at 6 weeks
Quality of life
Tidsramme: Assessments at baseline and at 6 weeks
Quality of life is measured by World Health Organization Quality of Life HIV Instrument
Assessments at baseline and at 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

31. oktober 2017

Først indsendt, der opfyldte QC-kriterier

2. november 2017

Først opslået (Faktiske)

7. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Telerehabilitation HIV

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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