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Determination Physical Activity Levels,Quality Life,Depression and Fatigue Severity Individuals With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PHYSICAL ACTIVITY LEVELS
DEPRESSION LEVELS
FATİGUE SEVERİTY
QUALITY OF LIFE
Sponsored by
Büşra Sarıkaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • clinical diagnosis of metabolic syndrome
  • to work as a volunteer those who agreed to participate

Exclusion Criteria:

  • No surgery in the last 3 months
  • with communication problem

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Working group

    Control Group

    Arm Description

    The data of the control group will be compared with the data of the study group.

    The data of the study group will be compared with the data of the control group.

    Outcomes

    Primary Outcome Measures

    Physical Activity Levels
    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.
    Life quality
    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.
    Depression Levels
    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.
    Fatigue Severity
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2021
    Last Updated
    April 5, 2023
    Sponsor
    Büşra Sarıkaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05184634
    Brief Title
    Determination Physical Activity Levels,Quality Life,Depression and Fatigue Severity Individuals With Metabolic Syndrome
    Official Title
    Determination of Physical Activity Levels,Quality of Life,Depression and Fatigue Severity of Individuals With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Büşra Sarıkaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. Demographic 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. The 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. 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. 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. 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. 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. The data will be analyzed with the SPSS package program. Appropriate statistical analysis will be made. After the data are obtained, it is aimed to evaluate the results and write a scientific thesis and publish it in an international journal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    214 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Working group
    Arm Type
    Active Comparator
    Arm Description
    The data of the control group will be compared with the data of the study group.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The data of the study group will be compared with the data of the control group.
    Intervention Type
    Other
    Intervention Name(s)
    PHYSICAL ACTIVITY LEVELS
    Intervention Description
    Determination of physical activity levels of MetS individuals
    Intervention Type
    Other
    Intervention Name(s)
    DEPRESSION LEVELS
    Intervention Description
    To determine the depression levels of MetS individuals
    Intervention Type
    Other
    Intervention Name(s)
    FATİGUE SEVERİTY
    Intervention Description
    To determine the severity of fatigue of MetS individuals
    Intervention Type
    Other
    Intervention Name(s)
    QUALITY OF LIFE
    Intervention Description
    To determine the quality of life of MetS individuals
    Primary Outcome Measure Information:
    Title
    Physical Activity Levels
    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.
    Time Frame
    3 minute
    Title
    Life quality
    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.
    Time Frame
    3 minute
    Title
    Depression Levels
    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.
    Time Frame
    3 minute
    Title
    Fatigue Severity
    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.
    Time Frame
    3 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of metabolic syndrome to work as a volunteer those who agreed to participate Exclusion Criteria: No surgery in the last 3 months with communication problem

    12. IPD Sharing Statement

    Learn more about this trial

    Determination Physical Activity Levels,Quality Life,Depression and Fatigue Severity Individuals With Metabolic Syndrome

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