Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-29 @ 3:07 AM
Study NCT ID:
NCT06943066
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Non-Specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '12 weeks', 'description': "A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'."}, {'measure': 'Oswestry Disability Index', 'timeFrame': '12 weeks', 'description': 'A 10-section questionnaire evaluating the impact of back pain on daily activities. maximum point 56'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': '12 weeks', 'description': 'A 9-item self-report scale where participants rate how fatigue affects their daily life on a 1-7 scale.'}, {'measure': 'Heart Rate Variability', 'timeFrame': '12 weeks', 'description': 'Measured using the Polar H10 sensor to evaluate autonomic nervous system activity during rest and activity.'}, {'measure': 'Trunk Flexor and Extensor Endurance Tests:', 'timeFrame': '12 weeks', 'description': 'Time-based static hold tests assessing core stabilization ability in flexion and extension positions.'}, {'measure': 'Plank Test', 'timeFrame': '12 weeks', 'description': 'Participant holds a forearm plank position, and the time until fatigue or form loss is recorded to assess core endurance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.', 'detailedDescription': 'The aim of this study is to compare the effects of different types of Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Aged between 18 and 60 years\n* Non-specific low back pain for more than 12 weeks\n* No clear pathological diagnosis\n* Physically and cognitively capable of performing the exercises\n* Pain level between 3 and 7 on the Visual Analog Scale (VAS) Exclusion Criteria\n* Pregnancy\n* Spinal surgery in the last 6 months\n* Neurological or chronic systemic diseases\n* Movement restriction due to severe pain'}, 'identificationModule': {'nctId': 'NCT06943066', 'briefTitle': 'Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Non-Specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effects of Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Individuals With Non-Specific Low Back Pain', 'orgStudyIdInfo': {'id': '2024-04-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reformer Pilates', 'interventionNames': ['Other: Reformer Pilates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pilates control', 'interventionNames': ['Other: Pilates control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'online pilates', 'interventionNames': ['Other: online pilates']}], 'interventions': [{'name': 'Reformer Pilates', 'type': 'OTHER', 'description': 'Reformer Pilates', 'armGroupLabels': ['Reformer Pilates']}, {'name': 'Pilates control', 'type': 'OTHER', 'description': 'Pilates control', 'armGroupLabels': ['Pilates control']}, {'name': 'online pilates', 'type': 'OTHER', 'description': 'online pilates', 'armGroupLabels': ['online pilates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34353', 'city': 'Istanbul', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'Hazal GENÇ', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hazal genc', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}