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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Behavioral: Exercise session; Behavioral: Control session

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphael Dias, PhD; Phone Number: +5519999406878; Email: raphaelritti@gmail.com
• Study Contact Backup: Name: Marilia Correia, PhD; Phone Number: +5511999711669; Email: marilia.correia@live.com

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Recruiting
    • Universidade Nove de Julho
    • Contact: Raphael Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; In the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes.	Behavioral: Exercise 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; Other Names: Rehabilitation; Flexibility; Resistance exercises; Cardiorespiratory exercises; Behavioral: Control session; Remain seated for 60 min
Other: Control; In the control session, participants will remain seated for 60 minutes.	Behavioral: Exercise 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; Other Names: Rehabilitation; Flexibility; Resistance exercises; Cardiorespiratory exercises; Behavioral: Control session; Remain seated for 60 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood pressure	Assessment of the systolic and diastolic blood pressure using an automatic device	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	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	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	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	Before, during and 5 minutes after the end of the exercise and control interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Assessment of heart rate using a heart rate monitor	Before and continuously during exercise and control interventions
Change in affective response	Assessment of affective response using a felling scale	Before and every 5 minutes during exercise and control interventions

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Study Chair: Raphael Dias, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: fatigue; rehabilitation; Covid-19; respiratory system; cardiovascular system; Post-Covid 19 Syndrome
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome; Syndrome
• Other Study ID Numbers: Acute_Covid; 0057/2022 (Other Identifier: CAPES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan to share the data after completion upon resonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No