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

University of Sao Paulo

Status: Unknown

Conditions: Post-acute COVID-19 Syndrome; Long COVID

Treatments: Other: Home-based physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT05360563

5.052.767

Details and patient eligibility

About

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).

Enrollment: 94 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Physical training group

Experimental group

Description:

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).

Treatment:

Other: Home-based physical training

Control group

No Intervention group

Description:

The control group will receive regular medical care.