Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-03 @ 12:09 PM
Study NCT ID:
NCT02430402
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coping (Effective Consumer Scale (EC17)', 'timeFrame': '12 months', 'description': 'Measured with Effective Consumer Scale (EC17)'}, {'measure': '30 second sit to stand test', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'EQ5D', 'timeFrame': '12 months'}, {'measure': 'Numerical Rating Scales (NRS) fatigue question', 'timeFrame': '12 months'}, {'measure': 'Hannover functional Scale', 'timeFrame': '12 months'}, {'measure': 'Coop Wonca', 'timeFrame': '12 months'}, {'measure': 'Hopkins Symptom Checklist', 'timeFrame': '12 months'}, {'measure': 'Patient Specific Functional scale', 'timeFrame': '12 months'}, {'measure': 'Numerical Rating Scales (NRS) pain question', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Climatotherapy'], 'conditions': ['Rheumatic Diseases']}, 'referencesModule': {'references': [{'pmid': '32179929', 'type': 'RESULT', 'citation': 'Nilssen IR, Koksvik HS, Gronning K, Steinsbekk A. Rehabilitation in warm climate for young adults with inflammatory arthritis: A 12-month randomized controlled trial. J Rehabil Med. 2020 Apr 14;52(4):jrm00040. doi: 10.2340/16501977-2666.'}]}, 'descriptionModule': {'briefSummary': 'Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inflammatory rheumatic disease\n* Self reliant in daily life\n\nExclusion Criteria:\n\n\\- conditions that might influence ability to fly to Spain and participate in rehabilitation in warm climate (Unstable heart disease, Serious lung disease, Chronic open ulcers, Serious mental health conditions, alcohol or drug addiction, Intolerant of sun and heat)'}, 'identificationModule': {'nctId': 'NCT02430402', 'briefTitle': 'Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '013.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Climate therapy', 'description': 'Climate therapy consisting of 3 week stay at rehabilitation facility in Spain', 'interventionNames': ['Other: Rehabilitation in warm climate']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care provided as needed / agreed between patient and health care providers'}], 'interventions': [{'name': 'Rehabilitation in warm climate', 'type': 'OTHER', 'armGroupLabels': ['Climate therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Institute for Social Medicine', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Aslak Steinsbekk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}