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

NCT ID: NCT05360563

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Long COVID Post-acute COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Home-based physical training

Intervention Type OTHER

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).

Control group

The control group will receive regular medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Central Contacts

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Bruno Gualano, PhD

Role: CONTACT

55112661 ext. 8021

Facility Contacts

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Bruno Gualano, PhD

Role: primary

551130918783

Other Identifiers

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5.052.767

Identifier Type: -

Identifier Source: org_study_id

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