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

NCT06248151 | Recruiting

• 2 other identifiers: Acute_Covid0057/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Post-Covid 19 Syndrome; Covid-19; fatigue; cardiovascular system; respiratory system; rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in heart rate

  Before and continuously during exercise and control interventions

• Change in affective response

  Before and every 5 minutes during exercise and control interventions

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

OTHER

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

Behavioral: Exercise session; Behavioral: Control session

Interventions

Exercise session BEHAVIORAL

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

Control; Exercise

Control session BEHAVIORAL

Remain seated for 60 min

Control; Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Fatigue

Interventions

Rehabilitation; Pliability

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mechanical Phenomena; Physical Phenomena

Study Officials

• Raphael Dias, PhD

  University of Nove de Julho

  STUDY CHAIR

Central Study Contacts

Raphael Dias, PhD

CONTACT

+5519999406878; raphaelritti@gmail.com

Marilia Correia, PhD

CONTACT

+5511999711669; marilia.correia@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 8, 2024
• Study Start: February 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: July 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

BR (1)