Post-Acute COVID-19 SyndromeExPostCovid-19NCT06248151
Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-COVID-19 Syndrome
A study testing Exercise session in people with Post-Acute COVID-19 Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of the study is to compare the acute cardiorespiratory and perceptual responses to a physical exercise session in those infected by Covid-19 with and without persistent symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- Exercise session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-Covid Syndrome group:
- have had a positive RT-PCR test for Covid-19;
- present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
- have the cognitive and physical capacity to perform the exercises; It is
- low cardiovascular risk classification according to the American College of Sports Medicine criteria.
- Healthy group:
Show all 9Show fewer
- not present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
- have the cognitive and physical capacity to perform the exercises; It is
- low cardiovascular risk classification according to the American College of Sports Medicine criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Nove de Julho
São Paulo, 01504-001
Raphael Dias
About this study
Official title: Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-Covid-19 Syndrome
The objective of the study is to compare the acute cardiorespiratory and perceptual responses to a physical exercise session in those infected by Covid-19 with and without persistent symptoms.
Read the detailed description
The study will be a crossover carried out in two groups (with and without persistent symptoms of Covid-19). Participants in both groups will undergo a control session and an exercise session and cardiorespiratory and perceptual responses will be obtained before, during and after the sessions. In the exercise session, participants will perform aerobic exercises, strength exercises and muscle stretching, while in the control session participants will remain seated. Blood pressure, heart rate, cardiac autonomic modulation, peripheral oxygen saturation, vascular function and perception of affect will be obtained.
- Conditions
- Post-Acute COVID-19 Syndrome
- Being tested
- Exercise session, Control session
- Keywords
- Post-Covid 19 Syndrome, Covid-19, fatigue, cardiovascular system, respiratory system, rehabilitation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise sessionBehavioural
Also called Rehabilitation, Cardiorespiratory exercises, Resistance exercises, Flexibility
Session will included aerobic, resistance and flexibility exercises and will last approximately 45 minutes. The session will begin with aerobic exercises (5 min jumping jacks and 5 min stationary walking). Then, nine strength exercises will be performed for the main muscle groups (3 times of 12 to 15 repetitions, with a 1-minute rest interval) and finally stretching for the main muscle groups
Control sessionBehavioural
Remain seated for 60 min
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | In the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes. Receives: Behavioral: Exercise session; Behavioral: Control session |
| Control | Other | In the control session, participants will remain seated for 60 minutes. Receives: Behavioral: Exercise session; Behavioral: Control session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure
Assessment of the systolic and diastolic blood pressure using an automatic device
Measured: Before and 30 and 50 minutes after the end of the exercise and control interventions
Change in Heart rate variability
Assessment of the heart rate variability indicators using a heart rate monitor
Measured: Before and 30 and 50 minutes after the end of the exercise and control interventions
Change in flow mediated dilation
Assessment of the flow mediated dilation using a doppler ultrasound
Measured: Before and 30 minutes after the end of the exercise and control interventions
Change in peak exhalation flow
Assessment of the peak exhalation flow using a peak flow device
Measured: Before and 5 minutes after the end of the exercise and control interventions
Change in oxygen saturation
Assessment of the peripheral oxygen saturation using a pulse oximeter
Measured: Before, during and 5 minutes after the end of the exercise and control interventions
Secondary outcomes (2)
Change in heart rate
Assessment of heart rate using a heart rate monitor
Measured: Before and continuously during exercise and control interventions
Change in affective response
Assessment of affective response using a felling scale
Measured: Before and every 5 minutes during exercise and control interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start15 Feb 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Dias, PhD, Study chair, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248151
- Sponsor's protocol ID
- Acute_Covid
- Other IDs
- 0057/2022
- Acronym
- ExPostCovid-19
- Status last verified
- Dec 2024
- First submitted
- 6 Feb 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share the data after completion upon resonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-Covid-19 Syndrome
- ClinicalTrials.gov ID
- NCT06248151
- Acronym / sponsor ID
- ExPostCovid-19 / Acute_Covid
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Post-Covid 19 Syndrome, Covid-19, fatigue, cardiovascular system, respiratory system, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 8 Feb 2024 (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 objective of the study is to compare the acute cardiorespiratory and perceptual responses to a physical exercise session in those infected by Covid-19 with and without persistent symptoms.
Detailed description
The study will be a crossover carried out in two groups (with and without persistent symptoms of Covid-19). Participants in both groups will undergo a control session and an exercise session and cardiorespiratory and perceptual responses will be obtained before, during and after the sessions. In the exercise session, participants will perform aerobic exercises, strength exercises and muscle stretching, while in the control session participants will remain seated. Blood pressure, heart rate, cardiac autonomic modulation, peripheral oxygen saturation, vascular function and perception of affect will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise session, Behavioral: Control sessionIn the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes. |
| Control | Other | Behavioral: Exercise session, Behavioral: Control sessionIn the control session, participants will remain seated for 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- have had a positive RT-PCR test for Covid-19;
- present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
- have the cognitive and physical capacity to perform the exercises; It is
- low cardiovascular risk classification according to the American College of Sports Medicine criteria.
- not present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
Key exclusion criteria (0 listed)
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 sessionAlso: Rehabilitation, Cardiorespiratory exercises, Resistance exercises, FlexibilitySession will included aerobic, resistance and flexibility exercises and will last approximately 45 minutes. The session will begin with aerobic exercises (5 min jumping jacks and 5 min stationary walking). Then, nine strength exercises will be performed for the main muscle groups (3 times of 12 to 15 repetitions, with a 1-minute rest interval) and finally stretching for the main muscle groups | Behavioural | Control, Exercise |
| Control sessionRemain seated for 60 min | Behavioural | Control, Exercise |
Primary outcome
Change in Blood pressure
Time frame: Before and 30 and 50 minutes after the end of the exercise and control interventions
Assessment of the systolic and diastolic blood pressure using an automatic device
Change in Heart rate variability
Time frame: Before and 30 and 50 minutes after the end of the exercise and control interventions
Assessment of the heart rate variability indicators using a heart rate monitor
Change in flow mediated dilation
Time frame: Before and 30 minutes after the end of the exercise and control interventions
Assessment of the flow mediated dilation using a doppler ultrasound
Change in peak exhalation flow
Time frame: Before and 5 minutes after the end of the exercise and control interventions
Assessment of the peak exhalation flow using a peak flow device
Change in oxygen saturation
Time frame: Before, during and 5 minutes after the end of the exercise and control interventions
Assessment of the peripheral oxygen saturation using a pulse oximeter
2 secondary outcomes
Change in heart rate
Time frame: Before and continuously during exercise and control interventions
Change in affective response
Time frame: Before and every 5 minutes during exercise and control interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided. Plan to share the data after completion upon resonable request
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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.
Raphael Dias, PhD study chair
University of Nove de Julho
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 session in people with Post-Acute COVID-19 Syndrome, run by University of Nove de Julho 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 9 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Dias, PhD (+5519999406878, raphaelritti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood pressure (time frame: Before and 30 and 50 minutes after the end of the exercise and control interventions). The study lists 5 primary outcomes in all. 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 Dec 2024.