Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05184634 |
| Other study ID # |
KÜ-BSarikaya-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
July 4, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Kirikkale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
