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Home-based Exercise in COVID-19 Survivors

10. juni 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treningsgruppe
Annen: 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 inngripen: Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. september 2020

Primær fullføring (Forventet)

30. september 2022

Studiet fullført (Forventet)

30. september 2022

Datoer for studieregistrering

Først innsendt

29. oktober 2020

Først innsendt som oppfylte QC-kriteriene

2. november 2020

Først lagt ut (Faktiske)

4. november 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 4.342.082

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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