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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360563
• Other study ID #: 5.052.767
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 55112661
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

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).

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.	Higher score means better outcome.	At baseline and after 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in total body weight (kg) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks
Secondary	Change from baseline in waist circumference (cm) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks
Secondary	Change from baseline in hip circumference (cm) at 16 weeks.	Higher score means worse outcome.	At baseline and after 16 weeks