Home-based Exercise in COVID-19 Survivors

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615052
• Other study ID #: 4.342.082
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2022
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 55112661
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS (Severe Acute Respiratory Syndrome)
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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