Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-31 @ 2:36 AM
Study NCT ID:
NCT02140866
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2014-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2014-05-02', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ultrasound Doppler', 'timeFrame': 'within 2 weeks post intervention'}], 'primaryOutcomes': [{'measure': 'The Assessment of Motor and Process Skills (AMPS) - the motor skill scale', 'timeFrame': 'within 2 weeks post intervention'}], 'secondaryOutcomes': [{'measure': 'The Assessment of Motor and Process Skills(AMPS) - the process skill scale', 'timeFrame': 'within 2 weeks post intervention'}, {'measure': 'The Activities of Daily Living Questionnaire (ADL-Q)', 'timeFrame': 'within 2 weeks post intervention'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': 'within 2 weeks post intervention'}, {'measure': 'Overall disease activity (DAS-28)', 'timeFrame': 'within 2 weeks post intervention'}, {'measure': 'Grip strength', 'timeFrame': 'within 2 weeks post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31242937', 'type': 'DERIVED', 'citation': 'Ellegaard K, von Bulow C, Ropke A, Bartholdy C, Hansen IS, Rifbjerg-Madsen S, Henriksen M, Waehrens EE. Hand exercise for women with rheumatoid arthritis and decreased hand function: an exploratory randomized controlled trial. Arthritis Res Ther. 2019 Jun 26;21(1):158. doi: 10.1186/s13075-019-1924-9.'}]}, 'descriptionModule': {'briefSummary': 'The study examines whether hand exercise therapy as an add on to a compensatory intervention program focused on joint protection, assistive devices and alternative methods of doing will improve the performance of ADL tasks requiring hand function in patients with rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female sex.\n* Age ≥ 18.\n* Diagnosis of rheumatoid arthritis (2).\n* Involvement of the hands, due to minimum one tender wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint in one of the hands.\n* Be on stable medication for at least 3 months prior to participation.\n* Self-reported decreased ability to perform personal and instrumental ADL tasks involving the hands.\n\nExclusion Criteria:\n\n* Significant osteoarthritis of the hand assessed at the initial examination by the rheumatologist\n* Hand surgery within 6 months of study participation\n* Other pain condition involving muscles and/or joints, e.g. fibromyalgia.\n* Prednisolon therapy, change in dose of biological agent or start of treatment with a new biological agent within the last 3 month before study start.\n* Inability to understand the information or to speak Danish\n* Any other condition that in the opinion of the investigator or accessing rheumatologist puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation.'}, 'identificationModule': {'nctId': 'NCT02140866', 'acronym': 'RAHExercise', 'briefTitle': 'Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial', 'organization': {'class': 'OTHER', 'fullName': 'Parker Research Institute'}, 'officialTitle': 'Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand Exercise', 'description': 'The intervention group will receive an exercise program for the hand/arm in combination with a compensatory intervention program (CIP).', 'interventionNames': ['Other: Hand Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Compensatory Intervention Program (CIP)', 'description': 'The control group will receive the Compensatory Intervention Program (CIP) only.', 'interventionNames': ['Other: Compensatory Intervention Program (CIP)']}], 'interventions': [{'name': 'Hand Exercise', 'type': 'OTHER', 'armGroupLabels': ['Hand Exercise']}, {'name': 'Compensatory Intervention Program (CIP)', 'type': 'OTHER', 'armGroupLabels': ['Compensatory Intervention Program (CIP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Frederiksberg', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Eva E Wæhrens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Parker Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parker Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oak Foundation', 'class': 'OTHER'}, {'name': 'Aase and Ejnar Danielsens Foundation', 'class': 'OTHER'}, {'name': 'Danish Physiotherapy Foundation', 'class': 'UNKNOWN'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Danish Association of Occupational Therapist', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher, PhD', 'investigatorFullName': 'Eva Ejlersen Wæhrens', 'investigatorAffiliation': 'Parker Research Institute'}}}}