Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

A Study of Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569642
• Other study ID #: IstanbulGalataUni
• Status: Completed
• Start date: June 13, 2022
• Est. completion date: December 27, 2023

Study information

• Verified date: June 2022
• Source: Istanbul Galata University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The components of MetS (abdominal obesity, high blood pressure, high serum glucose, high triglyceride level and low HDL-C) differ according to demographic characteristics such as age, gender and comorbidities. Low physical activity level, genetic makeup, nutritional disorders, decreased muscle strength and low cardiorespiratory fitness can be counted among the risk factors associated with MetS. In our study, it was aimed to examine the relationship between the components of the MetS and muscle strength, physical activity, functional capacity and quality of life. Our secondary aim is to investigate the independent effects of different components of MetS on each parameter.

Description:

The participants' sociodemographic characteristics such as age, height, weight, body mass index, waist circumference, marital status and education level, and anthropometric measurements, body fat percentage distributions, fasting blood glucose, HbA1c and lipid profiles will be recorded from previous analysis reports. Lower extremity quadriceps muscle strength Hand-held dynamometer, grip strength hand dynamometer, physical activity level International Physical Activity Questionnaire-Short Form-IPAQ-SF, number of steps pedometer, functional capacity 6 minute walking test and quality of life will be evaluated with the European Quality of Life Scale-5 Dimension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 27, 2023
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• To be diagnosed with MetS by an Internal Medicine Specialist according to NCEP-ATP III criteria

• Finding abdominal obesity component according to TURDEP-II criteria

• Being between the ages of 40-65

• To be able to read and write Turkish

• Having signed the informed consent form

Exclusion Criteria:

• Lack of cooperation

• Those with severe peripheral or central neurological disorders

• Patients with uncontrolled hypertension and uncontrolled arrhythmia

• Pregnant or breastfeeding patients

• Those with diabetic ulcer or neuropathy

• Chronic kidney failure (eGFR<30 ml/min)

• Chronic liver disease (ALT/AST<3X Normal upper limit)

• Those with serious respiratory system disease

• Patients with cardiac pacemaker

• History of previous stroke or myocardial infarction

• Presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Endocrinology and Metabolic Diseases	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Galata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Lower Extremity Muscle Strength	Measurement of Lower Extremity Muscle Strength: A hand-held dynamometer will be used to evaluate quadriceps muscle strength. While the individual is in the sitting position, the arms will be crossed over the chest and the hips and knees will be flexed to 90º. Then, the individual will be asked to bring the knee to full extension and make a maximal voluntary contraction for 5 seconds against the resistance applied by the dynamometer placed on the distal part of the leg. The average value will be recorded in kg/Newton.	7 minutes.
Primary	The 6-minute walking test (6MWT)	Functional Capacity Measurement: The 6-minute walking test (6MWT) will be used to evaluate the functional exercise capacity of individuals. The 6MWT is a valid and reliable test, easy to administer, well tolerated, and more reflective of activities of daily living than other tests. The test will be applied according to the criteria of the American Thoracic Society (ATS). Patients will rest for at least 10 minutes before the test. They will then be asked to walk as fast as they can but without running in 6 minutes on a straight 30-meter corridor. During the test they will be encouraged to walk fast using their maximum speed. Oxygen saturation and heart rates of the patients before and after the test will be evaluated with Baseline® finger pulse oximeter, systolic and diastolic blood pressures with sphygmomanometer, dyspnea and fatigue levels will be evaluated with Modified Borg Scale. At the end of the test, the distance that patients can walk (6MWM) will be recorded in meters.	6 minutes.
Primary	Physical activity levels of individuals will be determined by IPAQ-SF scale	Physical activity levels of individuals will be determined by IPAQ-SF. In the study, the self-administered short form of the questionnaire, which includes "the last seven days", will be used to evaluate the level of physical activity. This short form consists of seven questions and provides information about sitting, walking, moderate-intensity activities, and time spent in vigorous activities. In addition, there is a sitting question to determine the sedentary time. However, it is not included in the scoring. Calculation of the total score of the short form includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. In the evaluation of all activities, the criterion is that each activity is done for at least 10 minutes at a time.	8 minutes.
Primary	Measurement of step counts by Pedometers	Step Count Measurement: Pedometers (pedometers); It is a portable, easy-to-use tool that can objectively measure the number of steps, kilometers walked, and is used to evaluate the level of daily physical activity. It is a sensor sensitive to mechanical movement during walking. Pedometers have been shown to be the most valid method for evaluating step counts. The individuals participating in our study will be introduced to the OMRON branded Walking style One 2.1 pedometer device, validated by De Craemer et al., and will be taught to use it. Then, individuals will be asked to carry this pedometer all day for a week, in the waist area or in the pocket. The pedometer used has the feature of recording the number of steps, energy expenditure level (kcal) and the time spent with active movement with its 3D sensor, 7-day retrospective memory. After one week of use, the data recorded with the pedometer will be taken.	The participant's step count will be tracked for 7 days.
Primary	Grip Strength Measurement	Grip Strength Measurement: A Jamar brand hydraulic type dynamometer will be used to measure the grip strength of the participants. It will be performed with the individual in a sitting position on an unsupported chair, shoulder adduction, elbow 90º flexion, forearm in neutral position, wrist in 0-30° extension and 0-15° ulnar deviation. Participants will be asked to squeeze the dynamometer with maximum effort for 5 seconds with their dominant hand and then leave it completely relaxed. The average of the obtained values will be recorded in "pounds".	5 minutes.