Clinical trial NCT04615052: Home-based Exercise in COVID-19 Survivors
Official title: Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
SARS (Severe Acute Respiratory Syndrome)
SARS-CoV Infection
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

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