Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT05896995
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2023-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Low Back Pain Disability Questionnaire', 'timeFrame': '6 weeks', 'description': 'It is a questionnaire to evaluate the disability levels and quality of life faced by patients due to low back pain. It was developed to evaluate pain-related limitation in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, sanding, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score.'}, {'measure': 'Beck Depression Scale', 'timeFrame': '6 weeks', 'description': 'This scale has been shown to accurately measure the level of depression. The scale consists of 21 questions with 4 options, each corresponding to 0-3 points, and the patient is asked to choose the appropriate sentence according to his condition in the last week. mood, pessimism, sense of failure, dissatisfaction, sense of guilt, sense of punishment, self-hatred, self-blame, desire for self-punishment, crying spells, irritability, social introversion, indecisiveness, deterioration of body perception, determination of workability, sleep disorders, 21 symptoms and behaviors including fatigue, fatigue, decreased appetite, weight loss, somatic complaints and loss of libido are questioned.'}, {'measure': 'Bakas Caregiver Impact Scale.', 'timeFrame': '6 weeks', 'description': 'It evaluates the opportunity and power of caregiving for caregivers. The scale includes a total of 15 questions scored between +3 (best aspect) and -3 (worst aspect). It is a Likert-type scale with questions from 1 to 7 according to the answers that are affected by creation or negative effects. The worst affected person can get 15 points and the best affected person can get 105 points. As the score rises, it takes shape as "good influence", and as the score decreases, it takes shape as "bad influence".'}, {'measure': 'Disability status assessment.', 'timeFrame': '6 weeks', 'description': 'A single EDSS score between 0-10 is determined according to the scores obtained from the functional systems. While 0 points on the scale indicate normality, 10 points indicate the way of death when MS is sufficient. In the scale, the first score that can be obtained after 0 is 1. It is a beloved scale to see if there is an index in case of disability.'}, {'measure': 'Multiple Sclerosis Quality of Life-54 (MSQOL-54)', 'timeFrame': '6 weeks', 'description': 'It consists of 54 items, 2 main groups, 12 subgroups and 2 independent items: body organs health and places mental health (BMS). BFS units are in 8 subgroups: physical health, limitation due to physical devices, pain sensation, fatigue, social functionality, health perception, health distress, sexual functionality. BFS and BMS scores, which are the two main groups of the MSQOL-54 scale, are scored between 0-100. The high score obtained from the scale determines the goodness of life quality.'}, {'measure': 'Algometer', 'timeFrame': '6 weeks', 'description': 'An objective method, a manual algometer device, was used to assess pain sensitivity to pressure. In this study, "Baseline Dolorimeter" was preferred. The measurement was aimed at the unilateral iliocostalis lumborum muscle. Individuals were asked to say as soon as the feeling of pressure turned into a feeling of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['back pain', 'multiple sclerosis'], 'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.', 'detailedDescription': 'Individuals with MS cannot perform self-care in many areas due to the problems they encounter during their daily life activities, and they need an individual who will take care of them and a lifelong care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Chronic low back pain he is 18-60 years old\n* No verbal communication barrier\n* Complaining of pain for more than three months\n* Volunteering of participants Exclusion Criteria\n* Absence of cognitive impairment (delirium, dementia, amnesia)\n* Exercise contraindications (uncontrolled medical conditions)\n* Caring for individuals with an unclear diagnosis of MS\n* Disagreeing with the measurements to be made or providing incomplete answers\n* Previous spinal surgery\n* Spinal and joint disorders other than lumbar disc herniation'}, 'identificationModule': {'nctId': 'NCT05896995', 'briefTitle': 'Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Investigation of the Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': '2023-07/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates Exercise', 'description': 'pilates exercise+ Mckenzie Exercise Six weeks, twice a week', 'interventionNames': ['Other: Pilates Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mckenzie Exercise', 'description': 'Mckenzie Exercise Six weeks, twice a week', 'interventionNames': ['Other: Mckenzie Exercise']}], 'interventions': [{'name': 'Pilates Exercise', 'type': 'OTHER', 'description': 'Pilates exercises target the deep muscles of the core, including the abdomen, lower back, hips, and glutes, while also engaging the whole body.', 'armGroupLabels': ['Pilates Exercise']}, {'name': 'Mckenzie Exercise', 'type': 'OTHER', 'description': 'The McKenzie Method emphasizes self-treatment and active patient involvement in the management of their condition. It involves a systematic assessment process to determine the most appropriate exercises and interventions for an individual based on their specific symptoms and movement responses.', 'armGroupLabels': ['Mckenzie Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', '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'}}}}