Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06253819
Other study ID # Gurbuz05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date July 5, 2024

Study information

Verified date February 2024
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 5, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 65 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 Exclusion Criteria: - Mini Mental Status Scale less than 24 - Presence of orthopaedic condition preventing physical activity - Having undergone cardiovascular surgery - Having a pacemaker

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 respiratory function Assessment of pulmonary function of individuals respiratory The function test is performed in a seated position with the shoulders relaxed in a chair without armrests, with back support, using the device. Lung volumes (FEV1/FVC) from the pulmonary function test are recorded. 5 minute
Secondary respiratory muscle strenght Respiratory muscle strength will be measured non-invasively. A respiratory muscle strength measuring device (Power Breathe International Ltd, UK) will be used for the assessment. For the assessment, the athletes were placed in a seated position in a back-supported chair without armrests, with shoulders relaxed and using a nose clip. The athletes were asked to take a deep breath through the device placed in the mouth and the maximum inspiratory pressure (cmH2O) obtained was recorded. The assessment was repeated 3 times and mean values were recorded. 2 minute
Secondary Quality of life, questionnaire questions on quality of life Barthel index,The Barthel Index is a detailed, unbiased, easily applicable, understandable scale that investigates the cause-effect relationship and evaluates all steps of activities of daily living. According to the Barthel Index, patients are evaluated as 0-20 points fully dependent, 21-61 points highly dependent, 62- 90 moderately dependent, 91-99 points mildly dependent and 100 points fully independent. In studies in which the Barthel Index was used, 60 points were taken as the limit and scores above 60 explain the ability to function independently. 2 minute
Secondary pain level Lanss Neuropathic Pain Scale, The pain scale is a simple but useful bedside test for the differential diagnosis of neuropathic pain and nociceptive pain. The LANSS consists of two parts; the first part, which is completed by the patient and the second part, which includes a brief physical examination by the physician. Five self-answered questions (maximum score 16 points) describe experiences associated with neuropathic pain (such as pins and needles, paresthesia, skin discolouration due to autonomic changes, electrification and burning pain). In the physical examination part (maximum score), the presence of allodynia is tested by touching the painful and non-painful area with cotton wool. If the score is 12 and above, it is classified as neuropathic pain, and if the score is below 12, it is classified as nociceptive pain. 5 minute
Secondary functional exercise capacity 6 min walk test, The 6-minute walk test has good reproducibility and correlation with other functional capacity measurements. The walking distance of a normal person in 6 minutes is 400-700m. A 30 metre track is set up. The patient is brought to the starting line. The patient is informed that he/she should walk on the track at his/her own walking pace for 6 minutes, that he/she can stop the test at any time if he/she has a complaint, that he/she can stop and rest if he/she needs during the test and that he/she should continue the test until the command "test is over" is given. And the stopwatch is started and the test is started with the command "test started" and the test is terminated with the command "test over". During the test, if the patient stops and rests and takes a break from the test, the stopwatch is not stopped. 10 minute
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A