Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03479957
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of change the participation rate in supervised cardiac rehabilitation', 'timeFrame': '12 weeks', 'description': 'Evaluation of change the participation rate can be enhanced using the REMOTE -CR system'}, {'measure': 'Patients experiences of REMOTE-CR and and exercise led via video link', 'timeFrame': '12 weeks', 'description': 'The study participants experience of the REMOTE-CR system and exercise sessions via video link will be evaluated using a questionnaire'}], 'primaryOutcomes': [{'measure': 'Change in submaximal aerobic exercise capacity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer'}], 'secondaryOutcomes': [{'measure': 'Muscle endurance capacity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift'}, {'measure': 'Isometric grip strength', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Isometric grip strength will be evaluated using a hydraulic hand dynamometer'}, {'measure': 'Self-reported physical activity using theInternational Physical Activity Questionnaire', 'timeFrame': 'Baseline and 12 weeks', 'description': 'International Physical Activity Questionnaire: Results will be presented as a continuous variable, total metabolic equivalent (MET) minutes per week, where a higher score indicates a higher physical activity level. Result will also be presented as a categorical variable:\n\nHigh Physical activity level: achieving a total physical activity of at least 3000 MET-minutes/week.\n\nModerate physical activity: achieving a minimum of at least 600 MET-minutes per week.\n\nLow physical activity level: not achieving the minimum of 600 MET minutes per week'}, {'measure': 'Self-reported physical activity using the physical activity scale br Frändin and Grimby', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Activity scale by Frändin and Grimby describes 6 levels of physical activity. The scale includes 6 items that ranges from 1 indicating mostly physically inactive to 6 indicating a very high physical activity level.'}, {'measure': 'Kinesiophobia (fear of movement)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Swedish version of the Tampa scale for Kinesiophobia Heart (TSK-SV Heart) The scale comprises 17 items assessing subjective rating of kinesiophobia. The total score varies between 17-68 and a score \\>37 defines a high level of kinesofobia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': 'Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled appointment with physiotherapist for follow-up after cardiac event: ----Myocardial Infarction (MI)\n* Per cutaneous coronary intervention (PCI) due to MI or angina pectoris\n* Open heart surgery due to coronary artery disease or valvar disease\n* Living in the catchment area of Heart centre, University Hospital of Umeå.\n\nExclusion Criteria:\n\n* Clinically unstable\n* Postoperative infection\n* Comorbidity affecting ability to participate in exCR'}, 'identificationModule': {'nctId': 'NCT03479957', 'acronym': 'RECREATION', 'briefTitle': 'Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l', 'orgStudyIdInfo': {'id': 'RemoteCR SWE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REMOTE-CR', 'description': 'Remotely monitored and coached exercise training in real time using the REMOTE-CR system. The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link.', 'interventionNames': ['Behavioral: REMOTE-CR']}, {'type': 'OTHER', 'label': 'Usual care', 'description': 'The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care).', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'REMOTE-CR', 'type': 'BEHAVIORAL', 'description': 'The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link. Remotely monitored exercise training sessions will be offered monday-friday 13.00-16.00.', 'armGroupLabels': ['REMOTE-CR']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care)', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Camilla Sandberg, PhD', 'role': 'CONTACT', 'phone': '+46907858441'}, {'name': 'Helena Cronesten, RPT', 'role': 'CONTACT', 'phone': '+46907858441'}], 'facility': 'Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Camilla Sandberg, PhD', 'role': 'CONTACT', 'email': 'camilla.sandberg@umu.se', 'phone': '+46907858441'}, {'name': 'Helena Cronesten, RPT', 'role': 'CONTACT', 'phone': '+46907858441'}], 'overallOfficials': [{'name': 'Camilla Sandberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Camilla Sandberg', 'investigatorAffiliation': 'Umeå University'}}}}