Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-02 @ 6:17 AM
Study NCT ID:
NCT04501432
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work load (W)', 'timeFrame': 'up to 12 months', 'description': 'Maximal work load (W) achieved in cycle ergometry test'}, {'measure': 'Work load % of predicted value', 'timeFrame': 'up to 12 months', 'description': 'Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted value'}, {'measure': 'Heart rate (bpm)', 'timeFrame': 'up to 12 months', 'description': 'Maximal heart rate (bpm) during cycle ergometry test'}, {'measure': 'Framingham Recurrent Coronary Heart Disease risk score', 'timeFrame': 'up to 12 months', 'description': 'Range 1% to 29%, higher percentage indicating worse risk estimate'}], 'secondaryOutcomes': [{'measure': 'Metabolic Equivalent (MET) minutes / week', 'timeFrame': 'up to 12 months', 'description': 'MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)'}, {'measure': 'Patient Experience', 'timeFrame': '5 months', 'description': 'Semi-structured qualitative interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Exercise Tolerance', 'Physical Activity', 'Qualitative Interview', 'Secondary Prevention', 'Social Distancing'], 'conditions': ['Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated drastic public health measures (national lockdown) on March 16, 2020, leading to closure of all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation to patients with urgent medical indications only.\n\nThis study aims to explore the impact of COVID-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary CVD prevention.\n\nThe study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design:\n\n1. What was the impact of the COVID-19-related lockdown on patients\' physical activity and physical fitness levels? (QUANT stage)\n2. What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)\n3. Which insights and learning points may be drawn from patients\' experiences during COVID-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (QUAL stage)\n\nThe study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme was interrupted by COVID-19 public health orders, including "lockdown".\n\nPatients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. This will be compared with patients\' most recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March 2020) from patient records. Additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the COVID-19 lockdown and thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A group of patients who regularly attended group-based cardiac rehabilitation exercise training at the study site until COVID-19 restrictions (national lockdown) came into force on 16th March 2020.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years and over)\n* Cardiovascular disease (CVD)\n* Currently enrolled in outpatient cardiac rehabilitation training at the study site\n* Informed consent\n\nExclusion Criteria:\n\n* Contraindications for cardiopulmonary exercise testing\n* Pathologies limiting exercise performance\n* Pregnancy or breastfeeding\n* Limited German language'}, 'identificationModule': {'nctId': 'NCT04501432', 'acronym': 'CODIS', 'briefTitle': 'Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig Boltzmann Institute for Digital Health and Prevention'}, 'officialTitle': 'Cardiac Rehabilitation and Ongoing Physical Activity During the Coronavirus Disease (COVID-19) Pandemic: An Exploratory Mixed-Methods Study', 'orgStudyIdInfo': {'id': '23_CODIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Rehabilitation', 'description': 'Participants will be recruited from a group of patients who regularly attended group-based cardiac rehabilitation exercise training at the study site until COVID-19 restrictions (national lockdown) came into force on 16th March 2020.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This study does not include an intervention', 'armGroupLabels': ['Cardiac Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Institute of Sports Medicine, Prevention and Rehabilitation', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Stefan T Kulnik, PhD MRes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig Boltzmann Institute for Digital Health and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig Boltzmann Institute for Digital Health and Prevention', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Sports Medicine, Prevention and Rehabilitation, Salzburg, Austria', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}