Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT04649528
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIIT for Inflammatory Rheumatic Disease: Man vs Machine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012213', 'term': 'Rheumatic Fever'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The exercise physiologist performing the maximal oxygen uptake pre and posttests was blinded with reguards to which intervention group the participants had been assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physiological measures', 'timeFrame': 'At baseline and after 10 weeks of HIIT', 'description': 'Maximal oxygen uptake'}], 'secondaryOutcomes': [{'measure': 'Change in health-related quality of life', 'timeFrame': 'At baseline and after 10 weeks of HIIT', 'description': 'Questionnaire (Norwegian RAND-36), scoring on a 0-100 scale with higher scores identifying better outcomes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VO2max', 'Cardiovascular health', 'Quality of life', 'Endurance exercise'], 'conditions': ['Inflammatory Rheumatism']}, 'referencesModule': {'references': [{'pmid': '34673536', 'type': 'DERIVED', 'citation': 'Haglo H, Wang E, Berg OK, Hoff J, Helgerud J. Smartphone-Assisted High-Intensity Interval Training in Inflammatory Rheumatic Disease Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Oct 21;9(10):e28124. doi: 10.2196/28124.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two modes of delivering high-intensity interval training (HIIT) in a population with inflammatory rheumatic disease over 10 weeks. One group will recieved HIIT supervised by a healthcare professional, the other group will perform self-monitored HITT with guidance by a smarthpone application.', 'detailedDescription': 'People with inflammatory rheumatic diseases (IRS) such as rheumatoid arthritis (RA), spondyloarthritis (SpA) and systemic lupus erythematosus (SLE) have been shown to have reduced cardiovascular fitness and quality of life than the general population. Cardiovascular health is the single most important factor of total mortality. It has been shown previously that individuals with IRS tolerate both endurance training, resulting in improvement in function and cardiovascular health while also having a positive effect on disease activity measured through inflammation, pain, joint health and fatigue. In recent years, studies have also been conducted that demonstrate both the safety and effect of aerobic 4x4min high-intensity interval training (HIIT) for patients with IRS.\n\nThis study will involve an intervention period consisting of 20 HIIT sessions. Participants are randomized into one of two training groups. One group will perform HIIT under the supervision of a healthcare professional. The other group will perform the same HIIT training with identical instructions, however they will be self-monitored with the aid and guidance of a mobilephone application.\n\nThe purpose of the intervention is to increase maximum oxygen uptake and improve quality of life. The intervention period will consist of 2 weekly sessions lasting approximately 35 minutes performed on non-consecutive days. The endurance training will consist of 4 intervals of 4 minutes duration, separated by a 3-4 minute active break and follows the principle of intensive aerobic interval training. Before and after the training period, identical testing (approximately 30-40 min) will be performed by both intervention groups. The testing will include measurements of work economy and maximal oxygen uptake in an endurance test. Additionally, quality of life questionnaires will be obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Inflammatory rheumatic disease\n\nExclusion Criteria:\n\n* Inability to complete the testing procedures\n* Pregancy\n* Not able to perform exercise intervention\n* Planed surgeries or other plans during initial exercise intervention period than directly will effect the testing or training.\n* Access to a smartphone\n* Less than 80% compliance of planned training sessions'}, 'identificationModule': {'nctId': 'NCT04649528', 'briefTitle': 'HIIT for Inflammatory Rheumatic Disease: Man vs Machine', 'organization': {'class': 'OTHER', 'fullName': 'Molde University College'}, 'officialTitle': 'Digitally Assisted High-intensity Interval Training in Inflammatory Rheumatic Disease Patients: Treatment by Man or Machine?', 'orgStudyIdInfo': {'id': 'HHRevma1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised HIIT', 'description': 'Exercise intervention, 20 supervised by healthcare professional', 'interventionNames': ['Behavioral: Effective endurance 4x4 training - Supervised']}, {'type': 'EXPERIMENTAL', 'label': 'APP HIIT', 'description': 'Exercise intervention, 20 self-monitored assisted by a mobilephone application', 'interventionNames': ['Device: Effective endurance 4x4 training - APP']}], 'interventions': [{'name': 'Effective endurance 4x4 training - Supervised', 'type': 'BEHAVIORAL', 'description': 'Exercise intervention utilizing 4x4min aerobic high-intensity interval training', 'armGroupLabels': ['Supervised HIIT']}, {'name': 'Effective endurance 4x4 training - APP', 'type': 'DEVICE', 'description': 'Exercise intervention utilizing 4x4min aerobic high-intensity interval training', 'armGroupLabels': ['APP HIIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7047', 'city': 'Trondheim', 'state': 'Please Select', 'country': 'Norway', 'facility': 'Myworkout - Medical Rehabilitation Clinic', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Jan Helgerud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molde University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}