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

NCT05360563 | Unknown

• 1 other identifier: 5.052.767
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Long COVID; Post-acute COVID-19 Syndrome

Keywords

Exercise; Telemedicine; Long COVID

Outcome Measures

Primary Outcomes (1)

• Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.

  Higher score means better outcome.

  At baseline and after 16 weeks

Secondary Outcomes (18)

• Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.

  At baseline and after 16 weeks

• Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.

  At baseline and after 16 weeks

• Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.

  At baseline and after 16 weeks

• Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.

  At baseline and after 16 weeks

• Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.

  At baseline and after 16 weeks

Study Arms (2)

Physical training group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will receive regular medical care.

Interventions

Home-based physical training 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).

Physical training group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Bruno Gualano, PhD

CONTACT

55112661; gualano@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 4, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

BR (1)