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RecruitingNCT06248151ExPostCovid-19Updated Dec 4, 2024

Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-COVID-19 Syndrome

An interventional study of Exercise session and Control session in Post-Acute COVID-19 Syndrome, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post-Acute COVID-19 Syndrome

Keywords

  • Post-Covid 19 Syndrome
  • Covid-19
  • fatigue
  • cardiovascular system
  • respiratory system
  • rehabilitation
03

In context

Post-Acute COVID-19 Syndrome

536 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 187 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 369 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

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:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Exercise

    In the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes.

    Behavioral: Exercise session · Behavioral: Control session

  • Other
    Control

    In the control session, participants will remain seated for 60 minutes.

    Behavioral: Exercise session · Behavioral: Control session

Interventions

  • BehavioralExercise session

    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

    Also known as: Rehabilitation, Cardiorespiratory exercises, Resistance exercises, Flexibility

  • BehavioralControl session

    Remain seated for 60 min

06

What researchers measure

Primary outcomes

  1. Change in Blood pressure

    Assessment of the systolic and diastolic blood pressure using an automatic device

    Time frame: Before and 30 and 50 minutes after the end of the exercise and control interventions

  2. Change in Heart rate variability

    Assessment of the heart rate variability indicators using a heart rate monitor

    Time frame: Before and 30 and 50 minutes after the end of the exercise and control interventions

  3. Change in flow mediated dilation

    Assessment of the flow mediated dilation using a doppler ultrasound

    Time frame: Before and 30 minutes after the end of the exercise and control interventions

  4. Change in peak exhalation flow

    Assessment of the peak exhalation flow using a peak flow device

    Time frame: Before and 5 minutes after the end of the exercise and control interventions

  5. Change in oxygen saturation

    Assessment of the peripheral oxygen saturation using a pulse oximeter

    Time frame: Before, during and 5 minutes after the end of the exercise and control interventions

Secondary outcomes

  1. Change in heart rate

    Assessment of heart rate using a heart rate monitor

    Time frame: Before and continuously during exercise and control interventions

  2. Change in affective response

    Assessment of affective response using a felling scale

    Time frame: Before and every 5 minutes during exercise and control interventions

07

Study locations

1 of 1 sites recruiting
  • Universidade Nove de Julho
    São Paulo, 01504-001, Brazil
    • Raphael Dias · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Plan to share the data after completion upon resonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06248151
Responsible party
Raphael Mendes Ritti Dias (Full Professor, University of Nove de Julho) — Principal investigator
First posted
Feb 8, 2024
Start date
Feb 15, 2024
Primary completion
Dec 30, 2024 (estimated)
Completion
Jul 30, 2025 (estimated)
Last update
Dec 4, 2024

Study contacts

Raphael Dias, PhD
Contact
raphaelritti@gmail.com
+5519999406878
Marilia Correia, PhD
Contact
marilia.correia@live.com
+5511999711669
Raphael Dias, PhD
study chair · University of Nove de Julho

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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