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

University of Sao Paulo1 site in 1 country50 target enrollmentSeptember 26, 2020

ConditionsCovid19 SARS (Severe Acute Respiratory Syndrome)SARS-CoV Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: University of Sao Paulo
Enrollment: 50
Locations: 1
Primary Endpoint: Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 26, 2020

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Responsible Party

Principal Investigator

Bruno Gualano

Professor

University of Sao Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.

Time Frame: Baseline and 16 weeks.

Higher score means better outcome.

Secondary Outcomes

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