Home-based Exercise in COVID-19 Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Other: Exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Gualano, PhD; Phone Number: 8021 55112661; Email: gualano@usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-030
    • Recruiting
    • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group	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.
No Intervention: Control group; The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.	Higher score means worse outcome.	Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides	Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.	Fasting serum concentrations of glucose and insulin.	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 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 muscular function assessed by Timed-Up and Go Test at 16 weeks.		Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.	Higher score means worse outcome.	Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 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.	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.		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.	Higher score means worse outcome.	Baseline and 16 weeks.
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.	Higher score means better outcome.	Baseline and one year.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.	Higher score means worse outcome.	Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at 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.	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.		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.

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 4.342.082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No