Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-28 @ 12:18 AM
Study NCT ID:
NCT01755832
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2012-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heated Pool Exercise Groups for Patients With Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2012-12-15', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activity', 'timeFrame': '40 weeks', 'description': 'How much do your health problems affect your ability to conduct daily activities? The outcome is assessed on a ten-point rating scale ranging from zero to ten with "0" representing "no affect" and "10" representing "extreme affect".'}, {'measure': 'Pain', 'timeFrame': '40 weeks', 'description': 'How much pain do you have at present? The outcome is measured on a ten-point numeric rating scale (NRS) ranging from zero to ten with "0" representing "no pain" and "10" representing "extreme pain".'}, {'measure': 'Fatigue', 'timeFrame': '40 weeks', 'description': 'How much fatigue do you have at present? The outcome is assesses on a ten-point rating scale ranging from zero to ten with "0" representing "no fatigue" and "10" representing "extreme fatigue"'}, {'measure': 'Stiffness', 'timeFrame': '40 weeks', 'description': 'How much stiffness do you have at present? The outcome is assessed on a ten-point numeric rating scale with "0" representing "no stiffness" and "10" representing "extreme stiffness".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inflammatory rheumatic joint disease', 'text message', '> 18 years', 'Norwegian speaking'], 'conditions': ['Rheumatic Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25490962', 'label': 'Full text article'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).', 'detailedDescription': 'The patients receive text messages on mobile phones twice a week for circa 40 weeks. The text messages ask for pain, fatigue, stiffness and ability to carry out everyday activities. The patients should respond with a number from 0 to 10, where 0 is no symptoms/no hindering of activity and 10 is worst symptoms/worst hindering of activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with inflammatory rheumatic joint diseases with a medical referral to group exercises in heated pool.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referral from a medical doctor to group exercises in heated pool\n* Inflammatory rheumatic joint disease\n* \\> 18 years\n* Stable disease\n* Mobile phone owner\n* Understand and use text messages on mobile phones\n\nExclusion Criteria:\n\n* Independent living\n* Joint surgery previous to the study start'}, 'identificationModule': {'nctId': 'NCT01755832', 'briefTitle': 'Heated Pool Exercise Groups for Patients With Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'National Resource Center for Rehabilitation in Rheumatology'}, 'officialTitle': 'Better Everyday-life With Heated Pool Exercise Groups for Patients With Inflammatory Rheumatic Diseases', 'orgStudyIdInfo': {'id': '2011/1654'}, 'secondaryIdInfos': [{'id': 'NRF2012', 'type': 'OTHER_GRANT', 'domain': "The Norwegian Rheumatism Association's Research Fund"}, {'id': 'OSL2012', 'type': 'OTHER_GRANT', 'domain': 'Oslo Sanitetsforenings Legater'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pool exercise group', 'description': 'Patients with inflammatory rheumatic disease', 'interventionNames': ['Procedure: Pool exercise']}], 'interventions': [{'name': 'Pool exercise', 'type': 'PROCEDURE', 'description': 'Group exercise in heated pool one hour per week for 12 weeks.', 'armGroupLabels': ['Pool exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0319', 'city': 'Oslo', 'country': 'Norway', 'facility': 'National resource center for rehabilitation in rheumatology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Anne Christie, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National resource centre for rehabilitation in rheumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Resource Center for Rehabilitation in Rheumatology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Anne Christie', 'investigatorAffiliation': 'National Resource Center for Rehabilitation in Rheumatology'}}}}