Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Home-based Exercise in COVID-19 Survivors

10. juni 2022 opdateret af: Bruno Gualano, University of Sao Paulo

Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial

The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Bruno Gualano, PhD
  • Telefonnummer: 8021 55112661
  • E-mail: gualano@usp.br

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 05508-030
        • Rekruttering
        • University of Sao Paulo

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

40 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with COVID-19
  • Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
  • Admitted in intensive care unit

Exclusion Criteria:

  • Cardiovascular disease
  • Resting dyspnea
  • Acute pulmonary embolism or pulmonary infarction
  • Deep venous thromboembolism
  • Uncontrolled visual or vestibular disorders
  • Pregnancy
  • Uncontrolled resting tachycardia
  • Uncontrolled hypertension
  • Uncontrolled Type II diabetes
  • Acute infections
  • Neurological disorders
  • Patients with chronic kidney disease who are in need of hemodialysis
  • Recent malignant neoplasm (<5 years)
  • Autoimmune diseases
  • Complex ventricular arrhythmias, atrial fibrillation or complete heart block
  • Transplant patients
  • Any physical disabilities that could hamper physical testing and exercise program

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Træningsgruppe
Andet: Exercise training
A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.
Ingen indgriben: Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means better outcome.
Baseline and 16 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Fasting serum concentrations of glucose and insulin.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Tidsramme: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Tidsramme: Baseline and one year.
Higher score means better outcome.
Baseline and one year.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Tidsramme: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at one year.
Tidsramme: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Tidsramme: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Tidsramme: Baseline and one year.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Tidsramme: Baseline and one year.
Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Tidsramme: Baseline and one year.
Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Tidsramme: Baseline and one year.
Baseline and one year.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Sao Paulo

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)

26. september 2020

Primær færdiggørelse (Forventet)

30. september 2022

Studieafslutning (Forventet)

30. september 2022

Datoer for studieregistrering

Først indsendt

29. oktober 2020

Først indsendt, der opfyldte QC-kriterier

2. november 2020

Først opslået (Faktiske)

4. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4.342.082

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Covid19

Kliniske forsøg med Exercise training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner