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Home-based Exercise in COVID-19 Survivors

10 juni 2022 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Träningsgrupp
Övrig: 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.
Inget ingripande: Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Tidsram: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Tidsram: Baseline and 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Tidsram: 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.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Tidsram: 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.
Tidsram: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: Baseline and one year.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Tidsram: Baseline and one year.
Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Tidsram: Baseline and one year.
Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Tidsram: Baseline and one year.
Baseline and one year.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Sao Paulo

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 september 2020

Primärt slutförande (Förväntat)

30 september 2022

Avslutad studie (Förväntat)

30 september 2022

Studieregistreringsdatum

Först inskickad

29 oktober 2020

Först inskickad som uppfyllde QC-kriterierna

2 november 2020

Första postat (Faktisk)

4 november 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juni 2022

Senast verifierad

1 juni 2022

Mer information

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Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 4.342.082

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