Covid19NCT04615052
Home-based Exercise in COVID-19 Survivors
A study testing Exercise training in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Covid19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2020to 30 Sep 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with COVID-19
- Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- Admitted in intensive care unit
Who cannot join
- Cardiovascular disease
- Resting dyspnea
- Acute pulmonary embolism or pulmonary infarction
- Deep venous thromboembolism
- Uncontrolled visual or vestibular disorders
- Pregnancy
Show all 17Show fewer
- Uncontrolled resting tachycardia
- Uncontrolled hypertension
- Uncontrolled Type II diabetes
- Acute infections
- Neurological disorders
- Patients with chronic kidney disease who are in need of hemodialysis
- Recent malignant neoplasm (<5 years)
- Autoimmune diseases
- Complex ventricular arrhythmias, atrial fibrillation or complete heart block
- Transplant patients
- Any physical disabilities that could hamper physical testing and exercise program
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, 05508-030
Bruno Gualano, Phd, 551130918783, gualano@usp.br
Bruno Gualano, Phd
About this study
Official title: Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
- Being tested
- Exercise training
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Other: Exercise training |
| Control group | No intervention | The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Higher score means better outcome.
Measured: Baseline and 16 weeks.
Secondary outcomes (35)
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Higher score means worse outcome.
Measured: Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Measured: Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Fasting serum concentrations of glucose and insulin.
Measured: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Measured: Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Higher score means worse outcome.
Measured: Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Higher score means worse outcome.
Measured: Baseline and 16 weeks.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Higher score means worse outcome.
Measured: Baseline and 16 weeks.
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Higher score means worse outcome.
Measured: Baseline and 16 weeks.
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Measured: Baseline and 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Higher score means better outcome.
Measured: Baseline and one year.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Higher score means worse outcome.
Measured: Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at one year.
Higher score means worse outcome.
Measured: Baseline and one year.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Higher score means worse outcome.
Measured: Baseline and one year.
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Measured: Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Measured: Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Measured: Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Measured: Baseline and one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start26 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT04615052
- Sponsor's protocol ID
- 4.342.082
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Longobardi I, Goessler K, de Oliveira Junior GN, Prado DMLD, Santos JVP, Meletti MM, de Andrade DCO, Gil S, Boza JASO, Lima FR, Gualano B, Roschel H. Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial. Br J Sports Med. 2023 Oct;57(20):1295-1303. doi: 10.1136/bjsports-2022-106681. Epub 2023 May 10.
PubMed 37164620
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04615052
- Acronym / sponsor ID
- 4.342.082
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 4 Nov 2020 (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 physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise training |
| Control group | No intervention | –The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with COVID-19
- Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- Admitted in intensive care unit
Key exclusion criteria (17 listed)
- Cardiovascular disease
- Resting dyspnea
- Acute pulmonary embolism or pulmonary infarction
- Deep venous thromboembolism
- Uncontrolled visual or vestibular disorders
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 |
|---|---|---|
| Exercise trainingA 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises. | Other | Exercise group |
Primary outcome
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Time frame: Baseline and 16 weeks.
Higher score means better outcome.
35 secondary outcomes
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on lipid profile at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on insulin sensitivity at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on body weight at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Time frame: Baseline and 16 weeks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Time frame: Baseline and 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Time frame: Baseline and one year.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Time frame: Baseline and one year.
Change from baseline on fatigue assessed by Chalder scale at one year.
Time frame: Baseline and one year.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Time frame: Baseline and one year.
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Time frame: Baseline and one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Time frame: Baseline and one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Time frame: Baseline and one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Time frame: Baseline and one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 37164620Longobardi I, Goessler K, de Oliveira Junior GN, Prado DMLD, Santos JVP, Meletti MM, de Andrade DCO, Gil S, Boza JASO, Lima FR, Gualano B, Roschel H. Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial. Br J Sports Med. 2023 Oct;57(20):1295-1303. doi: 10.1136/bjsports-2022-106681. Epub 2023 May 10.
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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 Exercise training in people with Covid19 and SARS (Severe Acute Respiratory 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 3 inclusion and 17 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 15 Jun 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 on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks. (time frame: Baseline and 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615052, which also lists 1 linked publication.
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 15 Jun 2022.