Clinical trial NCT05360563: Home-based Exercise Program in Patients With the Post-COVID-19 Condition
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long COVID
Post-acute COVID-19 Syndrome
Keywords: Exercise
Telemedicine
Long COVID
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
timeFrame: At baseline and after 16 weeks
Secondary outcomes:
measure: Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: 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.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in total body weight (kg) at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in waist circumference (cm) at 16 weeks.
timeFrame: At baseline and after 16 weeks
measure: Change from baseline in hip circumference (cm) at 16 weeks.
timeFrame: At baseline and after 16 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References: