Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-31 @ 1:23 PM
Study NCT ID:
NCT05770505
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of E-health Based Exercise Intervention After COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiorespiratory fitness', 'timeFrame': 'After 6 months intervention', 'description': 'Peak oxygen uptake'}, {'measure': 'Feasibilty', 'timeFrame': 'After 6 months intervention', 'description': 'Measured as acceptability and adherence'}], 'secondaryOutcomes': [{'measure': 'Lung function', 'timeFrame': 'After 6 months intervention', 'description': 'Spirometry'}, {'measure': 'Quality of life', 'timeFrame': 'After 6 months intervention', 'description': 'Questionnaires (RAND-12)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Reduced subjective and objective functional capacity performance are reported after COVID-19 in a large proportion of subjects. The aim of this study is to examine the feasibility and effect of using an e-health tool for guidance and tracking of exercise training in a general population of adults previously infected by COVID-19.', 'detailedDescription': 'Both hospitalized and non-hospitalized persons who have undergone extensive multi-disciplinary rehabilitation programs report significantly improved physical function after rehabilitation. Exercise training may be the key intervention to improve fitness and subjective complaints such as fatigue, low physical fitness and dyspnea after COVID-19 infection. However, traditional group-based exercise training or self-training programs at fitness centers have been shut down during the pandemic, and home-based interventions are warranted. To overcome the limitations and costs of a fitness center/personal trainer-based intervention study, more knowledge on the effectiveness and efficacy of using an e-Health system to recruit, train and monitor participants after illness are needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who have undergone COVID-19 disease\n* People who struggle to be physically active enough as a result of corona disease\n* People who experience reduced physical fitness as a result of corona disease\n\nExclusion Criteria:\n\n\\-- more than 100 PAI per week (calculated from self-reported activity level)\n\n* uncontrolled hypertension (high blood pressure) (over 200/110).\n* symptomatic valve failure, hypertrophic cardiomyopathy, unstable angina, pulmonary\n* hypertension, heart failure and/or severe rhythm disturbances\n* cancer that makes participation impossible or exercise contraindicated. Considered individually in consultation with the attending physician.\n* chronic contagious infectious diseases.\n* Participates in other studies that are not compatible with participation in this project\n* Post-exertional symptom exacerbation (PESE)/post-exertional malaise (PEM)/post-exertional neuroimmune exhaustion (PENE).'}, 'identificationModule': {'nctId': 'NCT05770505', 'briefTitle': 'Use of E-health Based Exercise Intervention After COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effect E-health Based Exercise Intervention After COVID-19', 'orgStudyIdInfo': {'id': '479316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised exercise', 'interventionNames': ['Behavioral: Exercise training using an e-health tool']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Exercise training using an e-health tool', 'type': 'BEHAVIORAL', 'description': 'Experimental: Exercise training will be guided by using the e-health tool MIA Health, with the possibility for digital communication between the participants and study personnel The participants will receive wearables that record heart rate. Participants will be encouraged to achieve 100 Personal Activity Intelligence (PAI) equivalents per week Control: No follow-up', 'armGroupLabels': ['Supervised exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Dorthe Stensvold Stensvold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dorthe Stensvold, Professor, NTNU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}