Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-01 @ 3:41 PM
Study NCT ID:
NCT05996692
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'through study completion, an average of one month', 'description': 'Fibromyalgia Impact Questionnaire is a survey developed to measure functional status in FM patients. This scale measures 10 separate aspects, namely physical impairment, feel good, work missed, do job, pain, fatigue, rested, stiffness, anxiety, and depression. The total score in the questionnaire is between 0 and 100. Higher scores demonstrate higher disease severity and lower functional status.'}, {'measure': 'The Tampa Scale for Kinesiophobia', 'timeFrame': 'through study completion, an average of one month', 'description': 'The Tampa Scale for Kinesiophobia is a reliable survey on fear of movement. In the survey consisting of 17 questions, the total score is between 17 and 68, with higher scores indicating higher kinesiophobia.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'through study completion, an average of one month', 'description': 'Overall pain intensity over the last 7 days was assessed with a Visual Analogue Scale (0 = no pain and 10 = the worst pain you can imagine).'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'through study completion, an average of one month', 'description': 'Pain Catastrophizing Scale is made up of 13 items scored on a 5-point Likert scale from 0 (never) to 4 (always). The total score is obtained with the sum of the answers, being able to obtain a maximum score of 52. Higher scores in the scale represent a higher tendency to catastrophize.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Walking', 'Adherence'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.', 'detailedDescription': 'Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.\n\nPurposes of this study were (1) to assess whether walking as exercise was prescribed by their physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate the frequency of patients who walk regularly as exercise, (3) to clinically compare patients who walk regularly as exercise and those who do not, and (4) to determine factors related to adherence to walking prescriptions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with FM according to the criteria of the American College of Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year', 'genderDescription': 'Since most of the patients with fibromyalgia are women, only female patients were included in the study, since a more homogeneous population was targeted.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be between 18-70 years old\n* female gender\n* Pharmacological therapy has been recommended in the last 1 year\n\nExclusion Criteria:\n\n* neurological disease or orthopedic problem presence that may be the reason of functional impairment\n* neurological deficit presence'}, 'identificationModule': {'nctId': 'NCT05996692', 'briefTitle': 'Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study', 'orgStudyIdInfo': {'id': '39'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who walked regularly for exercise', 'description': 'Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.\n\nAccording to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.', 'interventionNames': ['Other: Evaluation of adherence to walking prescriptions']}, {'label': 'Patients who did not walk regularly for exercise', 'description': 'Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.\n\nAccording to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.', 'interventionNames': ['Other: Evaluation of adherence to walking prescriptions']}], 'interventions': [{'name': 'Evaluation of adherence to walking prescriptions', 'type': 'OTHER', 'description': 'Adherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.', 'armGroupLabels': ['Patients who did not walk regularly for exercise', 'Patients who walked regularly for exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Gaziler Physical Medicine and Rehabilitation Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yasin Demir', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}