Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT06248151
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-COVID-19 Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D018583', 'term': 'Pliability'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Blood pressure', 'timeFrame': 'Before and 30 and 50 minutes after the end of the exercise and control interventions', 'description': 'Assessment of the systolic and diastolic blood pressure using an automatic device'}, {'measure': 'Change in Heart rate variability', 'timeFrame': 'Before and 30 and 50 minutes after the end of the exercise and control interventions', 'description': 'Assessment of the heart rate variability indicators using a heart rate monitor'}, {'measure': 'Change in flow mediated dilation', 'timeFrame': 'Before and 30 minutes after the end of the exercise and control interventions', 'description': 'Assessment of the flow mediated dilation using a doppler ultrasound'}, {'measure': 'Change in peak exhalation flow', 'timeFrame': 'Before and 5 minutes after the end of the exercise and control interventions', 'description': 'Assessment of the peak exhalation flow using a peak flow device'}, {'measure': 'Change in oxygen saturation', 'timeFrame': 'Before, during and 5 minutes after the end of the exercise and control interventions', 'description': 'Assessment of the peripheral oxygen saturation using a pulse oximeter'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'Before and continuously during exercise and control interventions', 'description': 'Assessment of heart rate using a heart rate monitor'}, {'measure': 'Change in affective response', 'timeFrame': 'Before and every 5 minutes during exercise and control interventions', 'description': 'Assessment of affective response using a felling scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Covid 19 Syndrome', 'Covid-19', 'fatigue', 'cardiovascular system', 'respiratory system', 'rehabilitation'], 'conditions': ['Post-Acute COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPost-Covid Syndrome group:\n\n* have had a positive RT-PCR test for Covid-19;\n* present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);\n* have the cognitive and physical capacity to perform the exercises; It is\n* low cardiovascular risk classification according to the American College of Sports Medicine criteria.\n\nHealthy group:\n\n* 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);\n* have the cognitive and physical capacity to perform the exercises; It is\n* low cardiovascular risk classification according to the American College of Sports Medicine criteria.'}, 'identificationModule': {'nctId': 'NCT06248151', 'acronym': 'ExPostCovid-19', 'briefTitle': 'Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-COVID-19 Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-Covid-19 Syndrome', 'orgStudyIdInfo': {'id': 'Acute_Covid'}, 'secondaryIdInfos': [{'id': '0057/2022', 'type': 'OTHER', 'domain': 'CAPES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'In the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes.', 'interventionNames': ['Behavioral: Exercise session', 'Behavioral: Control session']}, {'type': 'OTHER', 'label': 'Control', 'description': 'In the control session, participants will remain seated for 60 minutes.', 'interventionNames': ['Behavioral: Exercise session', 'Behavioral: Control session']}], 'interventions': [{'name': 'Exercise session', 'type': 'BEHAVIORAL', 'otherNames': ['Rehabilitation', 'Cardiorespiratory exercises', 'Resistance exercises', 'Flexibility'], 'description': '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', 'armGroupLabels': ['Control', 'Exercise']}, {'name': 'Control session', 'type': 'BEHAVIORAL', 'description': 'Remain seated for 60 min', 'armGroupLabels': ['Control', 'Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01504-001', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Raphael Dias', 'role': 'CONTACT'}], 'facility': 'Universidade Nove de Julho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Raphael Dias, PhD', 'role': 'CONTACT', 'email': 'raphaelritti@gmail.com', 'phone': '+5519999406878'}, {'name': 'Marilia Correia, PhD', 'role': 'CONTACT', 'email': 'marilia.correia@live.com', 'phone': '+5511999711669'}], 'overallOfficials': [{'name': 'Raphael Dias, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Plan to share the data after completion upon resonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Raphael Mendes Ritti Dias', 'investigatorAffiliation': 'University of Nove de Julho'}}}}