Long COVIDNCT05360563
Home-based Exercise Program in Patients With the Post-COVID-19 Condition
A study testing Home-based physical training in people with Long COVID and Post-acute COVID-19 Syndrome, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Long COVID, Post-acute COVID-19 Syndrome
- What is being tested?
- Home-based physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- May 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo
São Paulo, 05403-010
Bruno Gualano, PhD, 551130918783, gualano@usp.br
Bruno Gualano, PhD
About this study
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
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
- Being tested
- Home-based physical training
- Keywords
- Exercise, Telemedicine, Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physical trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Home-based physical training |
| Control group | No intervention | The control group will receive regular medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Higher score means better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 16 weeks
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 16 weeks
Change from baseline in total body weight (kg) at 16 weeks.
Higher score means worse outcome.
Measured: At baseline and after 16 weeks
Change from baseline in waist circumference (cm) at 16 weeks.
Higher score means worse outcome.
Measured: At baseline and after 16 weeks
Change from baseline in hip circumference (cm) at 16 weeks.
Higher score means worse outcome.
Measured: At baseline and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360563
- Sponsor's protocol ID
- 5.052.767
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05360563
- Acronym / sponsor ID
- 5.052.767
- Conditions
- Long COVID, Post-acute COVID-19 Syndrome
- Keywords
- Exercise, Telemedicine, Long COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical training group | Experimental | Other: Home-based physical trainingIn addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals). |
| Control group | No intervention | –The control group will receive regular medical care. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based physical trainingPatients 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). | Other | Physical training group |
Primary outcome
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
Time frame: At baseline and after 16 weeks
Higher score means better outcome.
18 secondary outcomes
Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
Time frame: 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.
Time frame: At baseline and after 16 weeks
Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and after 16 weeks
Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
Time frame: 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.
Time frame: At baseline and after 16 weeks
Change from baseline in total body weight (kg) at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in waist circumference (cm) at 16 weeks.
Time frame: At baseline and after 16 weeks
Change from baseline in hip circumference (cm) at 16 weeks.
Time frame: At baseline and after 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based physical training in people with Long COVID and Post-acute COVID-19 Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (55112661 ext. 8021, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks. (time frame: At baseline and after 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.