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

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: Not yet recruiting
• Conditions: Long COVID; Post-acute COVID-19 Syndrome
• Intervention / Treatment: Other: Home-based physical training

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	Higher score means better outcome.	At baseline and after 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 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.	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.	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.	Higher score means better outcome.	At baseline and after 16 weeks
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Higher score means better outcome.	At baseline and after 16 weeks
Change from baseline in total body weight (kg) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks
Change from baseline in waist circumference (cm) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks
Change from baseline in hip circumference (cm) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Exercise; Long COVID
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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