NCT05938153

Brief Summary

Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. Factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (MetS) and its components. Frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. Frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. Frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. As a result of aging, degenerative changes in the central and peripheral vestibular system have been found. With age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. This directly affects balance and postural control, leading to an increased risk of falls. In the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. Based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

December 24, 2025

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 3, 2023

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Geriatric Locomotive Function Scale:

    This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.

    10 minute

Secondary Outcomes (3)

  • Chair sit-lie test

    5 minute

  • Two-minute step test

    2 minute

  • Weight lifting test

    2 minute

Study Arms (1)

geriatrics individuals

Other: observational physical tests

Interventions

Geriatric Locomotive Function Scale: This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.

geriatrics individuals

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 65 and over, 10 individuals

You may qualify if:

  • Individuals aged 65 and over,
  • Volunteering to participate in the research
  • No cooperation and communication problems

You may not qualify if:

  • Individuals with neurological and orthopedic problems
  • Uncontrolled hypertension
  • Those with cardiac disorders
  • Those with cooperation and communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Kırıkkale, 71450, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 10, 2023

Study Start

June 1, 2023

Primary Completion

November 1, 2024

Study Completion

January 20, 2025

Last Updated

December 24, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations