Home-based Exercise in COVID-19 Survivors

June 10, 2022 updated by: Bruno Gualano, University of Sao Paulo

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 16 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Time Frame: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Time Frame: Baseline and 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Time Frame: Baseline and 16 weeks.
Fasting serum concentrations of glucose and insulin.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Time Frame: Baseline and 16 weeks.
Higher score means worse outcome.
Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Time Frame: Baseline and 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.
Time Frame: Baseline and 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.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Time Frame: Baseline and 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.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Time Frame: Baseline and 16 weeks.
Baseline and 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Time Frame: Baseline and 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.
Time Frame: Baseline and one year.
Higher score means worse outcome.
Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at one year.
Time Frame: Baseline and 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.
Time Frame: Baseline and 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.
Time Frame: Baseline and one year.
Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Time Frame: Baseline and one year.
Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Time Frame: Baseline and one year.
Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Time Frame: Baseline and one year.
Baseline and one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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