Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT03597451
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'strength of extremity muscles', 'timeFrame': 'baseline', 'description': 'The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).'}], 'secondaryOutcomes': [{'measure': '6 minutes walking test', 'timeFrame': 'baseline', 'description': 'The Six-Minute Walking Test (6MWT) was performed to determine walking capacity.'}, {'measure': 'timed up and go test', 'timeFrame': 'baseline', 'description': 'Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.'}, {'measure': 'sit-to-stand test', 'timeFrame': 'baseline', 'description': 'In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times.'}, {'measure': 'Side Bridge Test (core muscles endurance)', 'timeFrame': 'baseline', 'description': 'The subjects were asked to lay on their left or right sides and to extend their legs fully. Then The subjects are asked to create a straight line with their body by lifting their hip from the floor.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.'}, {'measure': 'Modified Biering-Sorensen test (core muscles endurance)', 'timeFrame': 'baseline', 'description': 'In this test, the subjects are asked to lie down on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, which allowed the upper body to be planked out over the edge. The subjects are asked to fold their arms on their chest and to put their hands on their shoulders. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.'}, {'measure': 'Trunk Flexion Test (core muscles endurance)', 'timeFrame': 'baseline', 'description': 'This test is initiated when the subjects are in a sit-up position with their back resting against a wedge that was angled 55° from the floor. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.'}, {'measure': 'Prone bridge test (core muscles endurance)', 'timeFrame': 'baseline', 'description': 'In this test, the subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight as they are required not to arch or bow. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['strength', 'walking', 'sit-to-stand'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '21493176', 'type': 'BACKGROUND', 'citation': 'Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.'}, {'pmid': '22562952', 'type': 'BACKGROUND', 'citation': 'Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.'}, {'pmid': '26562753', 'type': 'BACKGROUND', 'citation': 'Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006.'}, {'pmid': '25647356', 'type': 'BACKGROUND', 'citation': 'Fry DK, Huang M, Rodda BJ. Core muscle strength and endurance measures in ambulatory persons with multiple sclerosis: validity and reliability. Int J Rehabil Res. 2015 Sep;38(3):206-12. doi: 10.1097/MRR.0000000000000109.'}, {'pmid': '15907272', 'type': 'BACKGROUND', 'citation': 'Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. doi: 10.1007/s11932-005-0064-y.'}]}, 'descriptionModule': {'briefSummary': 'Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.\n\nThe effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.\n\nIn this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.', 'detailedDescription': 'Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.\n\nInvestigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p\\<0,05'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'MS patients who are ambulatory', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who 18-65 years of age\n* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.\n\nExclusion Criteria:\n\n* Participants who have orthopedic, vision, hearing, or perception problems'}, 'identificationModule': {'nctId': 'NCT03597451', 'briefTitle': 'The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '435'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple sclerosis', 'description': 'Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)'}, {'label': 'Control', 'description': 'Healthy individuals of similar age and sex to patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Cagla Ozkul', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cagla Ozkul', 'investigatorAffiliation': 'Gazi University'}}}}