Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-03-05 @ 2:50 PM
Study NCT ID:
NCT03255460
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2017-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2017-08-12', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue severity', 'timeFrame': 'Five minutes', 'description': 'Fatigue Severity Scale'}, {'measure': 'Fatigue', 'timeFrame': 'Eight minutes', 'description': 'Fatigue Impact Scale'}, {'measure': 'Physical activity behavior', 'timeFrame': 'Three days', 'description': 'Evaluated using an ActiGraph (GT3X+)'}, {'measure': 'Physical activity', 'timeFrame': 'Five minutes', 'description': 'International Physical Activity Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Functional exercise capacity', 'timeFrame': 'Fifteen minutes', 'description': 'Evaluated using 6-minute walking test'}, {'measure': 'Balance', 'timeFrame': 'Fifteen minutes', 'description': 'Evaluated using Bio Sway \\[(BSS) Biodex Inc.,Shirley, New York\\]'}, {'measure': 'Functional Mobility', 'timeFrame': 'Two minutes', 'description': 'Evaluated using Time and Go test'}, {'measure': 'Muscle strength', 'timeFrame': 'Fifteen minutes', 'description': 'Evaluated using digital hand dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Fatigue', 'Physical Activity', 'Exercise'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Is+Physical+Behavior+Affected+in+Fatigued+Persons+With+Multiple+Sclerosis%3F', 'label': 'related info'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Measuring+Activity+Patterns+Using+Actigraphy+in+Multiple+Sclerosis', 'label': 'related info'}]}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.\n\nFatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.\n\nIn the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.\n\nAs a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.', 'detailedDescription': 'According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Power analysis was performed using "G \\* Powerversion3.1 program" in order to determine the minimum number of subjects to be taken into operation. Accordingly, the number of participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group (n) = 37).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Having a diagnosis of "Multiple Sclerosis" by a specialist physician\n* Relapse free in the last 3 mounts\n* Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )\n* No diagnosis of depression\n\nExclusion Criteria:\n\n* Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research'}, 'identificationModule': {'nctId': 'NCT03255460', 'briefTitle': 'The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'Gazi 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis individuals', 'description': 'Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered.'}, {'label': 'Healthy individuals', 'description': 'Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Kader Çekim, Pt', 'role': 'STUDY_CHAIR', 'affiliation': 'Research assistant'}, {'name': 'Arzu Güçlü Gündüz, Pt, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor'}, {'name': 'Ceyla İrkeç, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Asisstant', 'investigatorFullName': 'Kader Eldemir', 'investigatorAffiliation': 'Gazi University'}}}}