Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT05184634
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination Physical Activity Levels,Quality Life,Depression and Fatigue Severity Individuals With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Levels', 'timeFrame': '3 minute', 'description': 'International Physical Activity Questionnaire (IPAQ): Physical activity level will be assessed with the short version of the IPAQ. The walking duration of the individuals in the last 1 week will be determined in terms of MET-minutes/week, whether they did moderate and severe PA, and if they did, how many days per week and total minutes they did. As a result, all values are added together to determine the total IPAQ score and will be categorized as inactive, minimally active, and very active.'}, {'measure': 'Life quality', 'timeFrame': '3 minute', 'description': "Quality of Life Scale-Short Form (SF-36) Form: It was collected with Quality of Life Scale-Short Form (SF 36). The Quality of Life Scale is accepted and applied as an individual's quality of life assessment scale. SF-36 was developed by Hays, Wells, Sherbourne, Rogers, and Spritzer (1995), and its Turkish reliability and validity study was performed by Koçyiğit, Aydemir, Ölmez, Fişek, and Memiş (1999). The SF-36 is a self-report scale and examines eight dimensions of health with 36 items, such as physical functioning, social functioning, role difficulties (physical and emotional), mental health, vitality (vitality), pain, and general perception of health. The scale provides an evaluation between zero and 100, and a higher score indicates a better level of health."}, {'measure': 'Depression Levels', 'timeFrame': '3 minute', 'description': 'Beck Depression Inventory (BDI): It is a self-assessment scale applied to healthy and psychiatric patient groups. Its purpose is to determine the risk for depression and to measure the level and severity of depressive symptoms. This form, which includes a total of 21 self-evaluation scales, provides a four-point Likert type measurement. Each item gets an increasing score between 0-3 and the total score is obtained by summing them up. A high total score indicates a high level of depression severity. It was developed by Beck et al. and adaptation, validity and reliability studies were conducted for the Turkish population. In the Turkish validity and reliability article of the scale, the cut-off point was determined as 17.'}, {'measure': 'Fatigue Severity', 'timeFrame': '3 minute', 'description': 'Fatigue Severity Scale (FAS): In the evaluation of the fatigue levels of the individuals, the Turkish validity and reliability of the TLS was used. This scale consists of nine items. Each item is scored between 1 and 7, and as the total score decreases, so does fatigue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to determine the Physical Activity Levels, Quality of Life, Depression and Fatigue Severity of Individuals with Metabolic Syndrome. International Physical Activity Questionnaire (IPAQ) to evaluate the physical activity level of individuals diagnosed with Metabolic Syndrome, to evaluate their quality of life SF-36 will be used to determine depression levels, Beck Depression Scale, and Fatigue Severity Scale (FSS) will be used to evaluate fatigue severity.', 'detailedDescription': "Individuals who were diagnosed with metabolic syndrome and volunteered to participate in the study will be included in our study. The number of individuals was determined according to the power analysis. G\\*Power (version 3.1.9.4) package program was used for power analysis. As a result of the power analysis made assuming that the effect size that can be obtained between the two groups will be large (d= 0.451 (EFFECT YOU), at least 214 people were included in the study (at least 107 people for each group)) at a 95% confidence level (with a margin of error of 0.05). It was calculated that 95% power could be obtained.After determining the number of individuals, the same number of normal healthy individuals who were not diagnosed with metabolic syndrome will be included in the study as the control group.Scales will be used to determine physical activity levels, Quality of life, Depression and Fatigue Severity in the control and study groups. Physical activity The International Physical Activity Questionnaire (IPAQ) will be used to assess the level of life, SF-36 will be used to assess their quality of life, the Beck Depression Scale will be used to determine depression levels, and the Fatigue Severity Scale (FSS) will be used to assess the severity of fatigue.\n\nDemographic information (name, surname, age, education level, occupation, marital status, background, family history, disease history, medication, smoking and alcohol use, regularly used drugs) of the individuals who will participate in the study will be recorded in the patient evaluation form.\n\nThe International Physical Activity Questionnaire (IPAQ) will be used to assess the level of physical activity, the SF-36 will be used to assess their quality of life, the Beck Depression Scale will be used to determine depression levels, and the Fatigue Severity Scale (FSS) will be used to assess the severity of fatigue.\n\nInternational Physical Activity Questionnaire (IPAQ): Physical activity level will be assessed with the short version of the IPAQ. The walking duration of the individuals in the last 1 week will be determined in terms of MET-minutes/week, whether they did moderate and severe PA, and if they did, how many days per week and total minutes they did. As a result, all values are added together to determine the total IPAQ score and will be categorized as inactive, minimally active, and very active.\n\nQuality of Life Scale-Short Form (SF-36) Form: It was collected with Quality of Life Scale-Short Form (SF 36). The Quality of Life Scale is accepted and applied as an individual's quality of life assessment scale. SF-36 was developed by Hays, Wells, Sherbourne, Rogers, and Spritzer (1995), and its Turkish reliability and validity study was performed by Koçyiğit, Aydemir, Ölmez, Fişek, and Memiş (1999). The SF-36 is a self-report scale and examines eight dimensions of health with 36 items, such as physical functioning, social functioning, role difficulties (physical and emotional), mental health, vitality (vitality), pain, and general perception of health. The scale provides an evaluation between zero and 100, and a higher score indicates a better level of health.\n\nBeck Depression Inventory (BDI): It is a self-assessment scale applied to healthy and psychiatric patient groups. Its purpose is to determine the risk for depression and to measure the level and severity of depressive symptoms. This form, which includes a total of 21 self-evaluation scales, provides a four-point Likert type measurement. Each item gets an increasing score between 0-3 and the total score is obtained by summing them up. A high total score indicates a high level of depression severity. It was developed by Beck et al. and adaptation, validity and reliability studies were conducted for the Turkish population. In the Turkish validity and reliability article of the scale, the cut-off point was determined as 17.\n\nFatigue Severity Scale (FAS): In the evaluation of the fatigue levels of the individuals, the Turkish validity and reliability of the TLS was used. This scale consists of nine items. Each item is scored between 1 and 7, and as the total score decreases, so does fatigue.\n\nThe data will be analyzed with the SPSS package program. Appropriate statistical analysis will be made.\n\nAfter the data are obtained, it is aimed to evaluate the results and write a scientific thesis and publish it in an international journal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of metabolic syndrome\n* to work as a volunteer those who agreed to participate\n\nExclusion Criteria:\n\n* No surgery in the last 3 months\n* with communication problem'}, 'identificationModule': {'nctId': 'NCT05184634', 'briefTitle': 'Determination Physical Activity Levels,Quality Life,Depression and Fatigue Severity Individuals With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'Determination of Physical Activity Levels,Quality of Life,Depression and Fatigue Severity of Individuals With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'KÜ-BSarıkaya-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Working group', 'description': 'The data of the control group will be compared with the data of the study group.', 'interventionNames': ['Other: PHYSICAL ACTIVITY LEVELS', 'Other: DEPRESSION LEVELS', 'Other: FATİGUE SEVERİTY', 'Other: QUALITY OF LIFE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The data of the study group will be compared with the data of the control group.', 'interventionNames': ['Other: PHYSICAL ACTIVITY LEVELS', 'Other: DEPRESSION LEVELS', 'Other: FATİGUE SEVERİTY', 'Other: QUALITY OF LIFE']}], 'interventions': [{'name': 'PHYSICAL ACTIVITY LEVELS', 'type': 'OTHER', 'description': 'Determination of physical activity levels of MetS individuals', 'armGroupLabels': ['Control Group', 'Working group']}, {'name': 'DEPRESSION LEVELS', 'type': 'OTHER', 'description': 'To determine the depression levels of MetS individuals', 'armGroupLabels': ['Control Group', 'Working group']}, {'name': 'FATİGUE SEVERİTY', 'type': 'OTHER', 'description': 'To determine the severity of fatigue of MetS individuals', 'armGroupLabels': ['Control Group', 'Working group']}, {'name': 'QUALITY OF LIFE', 'type': 'OTHER', 'description': 'To determine the quality of life of MetS individuals', 'armGroupLabels': ['Control Group', 'Working group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Kırıkkale Üniversitesi', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Büşra Sarıkaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Büşra Sarıkaya', 'investigatorAffiliation': 'Kırıkkale University'}}}}