Home-based Exercise Program in Patients With the Post-COVID-19 Condition

May 3, 2022 updated by: Bruno Gualano, University of Sao Paulo

Effects of a Home-based Exercise Program on the Functional Sequelae of Patients With the Post-COVID-19 Condition: A Randomized Controlled Trial

The management of the sequelae of COVID-19 is described as the next great challenge of global public health. Multiple symptoms may compose the clinical picture of these patients (eg, fatigue, dyspnea, cognitive dysfunction, myalgia and others), persisting for more than a year and frequently causing clinically important functional impairment. Thus, a clinical trial will be conducted to investigate the effects of a remotely supervised home-based exercise program on functional sequelae of patients diagnosed with the post-COVID-19 condition (also known as Long COVID).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.
94

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, 05403-010
        • University of Sao Paulo
        • Sub-Investigator:
          • Jhonnatan Santos, MS

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COVID-19 diagnostic history confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) or rapid antigen test (with clinical presentations of moderate to critical severity).
  • Diagnosis of post-COVID-19 condition according to World Health Organization criteria.
  • Present ≥1 symptoms at study admission, including dyspnea, fatigue, muscle weakness and/or musculoskeletal pain.
  • Have internet access at home.

Exclusion Criteria:

  • Being under clinical or experimental treatment for the post-COVID-19 condition.
  • Any physical disabilities that could hamper physical testing and exercise program.
  • Patients with major neuropsychiatric disorders (eg, dementia or severe depression).
  • Patients with chronic kidney disease who are in need of hemodialysis.
  • Solid organ transplant patients.
  • Complex ventricular arrhythmias, atrial fibrillation or complete heart block.
  • Recent malignant neoplasm.
  • Recent deep venous thromboembolism.
  • Acute pulmonary embolism or pulmonary infarction.
  • Uncontrolled hypertension.
  • Uncontrolled type II diabetes.
  • Uncontrolled vestibular disorders.
  • Acute infections.
  • Pregnancy.

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: None (Open Label)

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: Physical training group
In addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals).
Other: Home-based physical training
Patients allocated to this group will participate in a 16-week home-based physical training program, structured in three weekly sessions of aerobic and muscle strengthening exercises (which also have components that stimulate flexibility and balance). A third of the weekly physical training sessions will be supervised via telemedicine (with video call) by a clinical exercise specialist, but all patients will have illustrated exercise booklets and a full-time remote support service available for the remaining sessions (via text or voice messages).
No Intervention: Control group
The control group will receive regular medical care.

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 in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 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 in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks
Change from baseline in functional capacity (from 0 to 4 degrees of functional limitation) assessed by the post-COVID-19 functional status (PCFS) scale at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks
Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks
Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means better outcome.
At baseline and after 16 weeks
Change from baseline in total body weight (kg) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks
Change from baseline in waist circumference (cm) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks
Change from baseline in hip circumference (cm) at 16 weeks.
Time Frame: At baseline and after 16 weeks
Higher score means worse outcome.
At baseline and after 16 weeks

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 (Anticipated)

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.
May 1, 2022

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.
December 1, 2023

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.
February 1, 2024

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).
May 2, 2022

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.
May 3, 2022

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.
May 4, 2022

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.
May 4, 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.
May 3, 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.
May 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 5.052.767

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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