NCT06253819

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, dyslipidaemia, impaired glycaemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low physical activity level may be caused by various factors such as environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. It has been reported that factors such as genetic differences, diet, physical activity, age, gender and eating habits affect the prevalence of (MetS) and its components. Metabolic syndrome is a fatal endocrinopathy that starts with insulin resistance and is accompanied by systemic disorders such as abdominal obesity, glucose intolerance or diabetes mellitus, dyslipidaemia, hypertension and coronary artery disease (CAD). Although the prevalence of metabolic syndrome, which is accepted as an important public health problem in both developed and developing countries, varies according to different geographical and ethnic characteristics, definitions used, age and gender characteristics of populations, it shows a global increase and is considered as a pandemic affecting 20% to 30% of the adult population in many countries. The likelihood of metabolic syndrome increases in geriatric individuals due to some changes caused by aging. In a study conducted in geriatric individuals in our country, the incidence of metabolic syndrome was reported as 36.0%. As a result of ageing, 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 functional capacity. In elderly individuals, tolerance to physical effort decreases due to a decrease in maximal oxygen consumption and maximal heart rate. Systolic and diastolic blood pressure increases. The number of respirations per minute increases in the elderly due to the difficulty in chest cage adaptation.Aging causes a decrease in the elasticity of the lung. The respiratory surface area, which is up to 75 square metres (m²) in young adults (due to damage to the inter-alveolar septum during aging), decreases by approximately 3 m² per decade. Systematic changes seen with aging also have negative effects on functional status and exercise endurance. In sarcopenia, which is defined as a decrease in muscle mass and strength with advancing age, there is an irreversible decrease in the number of muscle fibres and myofibrils contained in each muscle fibre. From the age of 20 years to 70 years, approximately 40% loss in muscle mass and 30-50% decrease in muscle strength occur. It is stated that this loss starts at the age of 25, but muscle mass and muscle strength are lost at a rate of 1% per year from the age of 50. In geriatric rehabilitation, patients' functionality, balance and fall problems have an important place. On the other hand, cardiac risk is increased in geriatric individuals and respiratory assessments have an important place. Metabolic syndrome is 7 times more common in individuals with maximal oxygen consumption (VO2 max) below 29 mL-kg-1 -min-1 than in those with VO2 max above 35.5 mL-kg-1 -min-1. Metabolic syndrome directly affects the pulmonary system. In the light of the results obtained from 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 reveal the effects of respiratory muscle strength, pulmonary function, exercise endurance and functional level in geriatric individuals with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

January 7, 2024

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • functional status

    30 second sit-stand test: The patient is asked to sit up and down as quickly as possible in a chair with a seat height of 43.2 cm and a supported back. The patient sits on the chair. He crosses his hands on his chest. 2 attempts are made before the test. The duration of 30 seconds is kept with a stopwatch and the number of sit-ups is noted. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness.

    3 minute

  • balance and function

    Time up go, The individual is asked to get up from the chair without using his/her hands and walk 3 metres at a normal walking speed, then turn around and walk back to the chair and sit down.

    2 minute

Secondary Outcomes (5)

  • respiratory function

    5 minute

  • respiratory muscle strenght

    2 minute

  • Quality of life, questionnaire questions on quality of life

    2 minute

  • pain level

    5 minute

  • functional exercise capacity

    10 minute

Study Arms (2)

geriatrics individuals with metabolic syndrome

Other: survey and physical test

geriatrics individuals without metabolic syndrome

Other: survey and physical test

Interventions

6 min. walking test respiratory function test 30 second sit-stand test respiratory muscle test tıme up and go corbin posture analysis Waist/Hip Circumference Ratio Glucose and Cholesterol values Lanss Neuropathic Pain Scale

geriatrics individuals with metabolic syndromegeriatrics individuals without metabolic syndrome

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

In Kırıkkale Merkez Hürriyet Family Health Centre, all elderly individuals aged 65 years and over who meet the inclusion and exclusion criteria and who volunteered to participate in the study will be collected by face-to-face interview method using evaluation forms.

You may qualify if:

  • years of age or older
  • To be able to communicate verbally
  • Being able to walk independently
  • To be able to read and write
  • Volunteering to participate in the study

You may not qualify if:

  • Mini Mental Status Scale less than 24
  • Presence of orthopaedic condition preventing physical activity
  • Having undergone cardiovascular surgery
  • Having a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic SyndromeRespiration Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant at physiotherapy and rehabilitation department

Study Record Dates

First Submitted

January 7, 2024

First Posted

February 12, 2024

Study Start

January 30, 2024

Primary Completion

April 15, 2024

Study Completion

December 5, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations