Covid19, SARS-CoV Infection, SARS (Severe Acute Respiratory Syndrome)
Conditions
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.
Interventions
OTHERExercise 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks. | Baseline and 16 weeks. | Higher score means better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on lipid profile at 16 weeks. | Baseline and 16 weeks. | Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides |
| Change from baseline on insulin sensitivity at 16 weeks. | Baseline and 16 weeks. | Fasting serum concentrations of glucose and insulin. |
| Change from baseline on inflammatory cytokine IL-1 at 16 weeks. | Baseline and 16 weeks. | — |
| Change from baseline on inflammatory cytokine IL-1ra 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 inflammatory cytokine IL-10 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 C-reactive Protein at 16 weeks. | Baseline and 16 weeks. | — |
| Change from baseline on Creatine Kinase 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 lean body mass assessed by Dual-energy absorptiometry 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 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 body weight 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 muscular function assessed by Timed-Stand Test at 16 weesks. | Baseline and 16 weeks. | — |
| Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks. | Baseline and 16 weeks. | Higher score means worse outcome. |
| Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks. | Baseline and 16 weeks. | Higher score means worse outcome. |
| Change from baseline on depression symptoms assessed by Back Scale at 16 weeks. | Baseline and 16 weeks. | Higher score means worse outcome. |
| Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks. | Baseline and 16 weeks. | Higher score means worse outcome. |
| 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 resting blood pressure assessed by an automated device at 16 weeks. | Baseline and 16 weeks. | — |
| Change from baseline on fatigue assessed by Chalder scale at 16 weeks. | Baseline and 16 weeks. | Higher score means worse outcome. |
| Change from baseline on heart rate variability assessed by heart rate monitor 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 quality of life assessed by the SF-36 health survey questionnaire at one year. | Baseline and one year. | Higher score means better outcome. |
| Change from baseline on fatigue evaluated by the fatigue severity scale at one year. | Baseline and one year. | Higher score means worse outcome. |
| Change from baseline on fatigue assessed by Chalder scale at one year. | Baseline and one year. | Higher score means worse outcome. |
| Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year. | Baseline and one year. | Higher score means worse outcome. |
| Change from baseline on muscular function assessed by Timed-Up and Go Test 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 strength assessed by handgrip test at one year. | Baseline and one year. | — |
| Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year. | Baseline and one year. | — |
| Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks. | Baseline and 16 weeks. | — |
Countries
Brazil
Contacts
Primary ContactBruno Gualano, PhD
Outcome results
None listed