Metabolic SyndromeNCT06253819
Investigation of Respiratory Functions, Exercise Endurance and Functional Capacity in Geriatric Individuals With Metabolic Syndrome
An observational study of Metabolic Syndrome and Respiratory Disease, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Respiratory Disease, Exercise Capacity
- What is being tested?
- survey and physical test
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2024to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Mini Mental Status Scale less than 24
- Presence of orthopaedic condition preventing physical activity
- Having undergone cardiovascular surgery
- Having a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- survey and physical test
- Medical subject headings
- Metabolic Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey and physical testOther
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
| Study group | Role | What they receive |
|---|---|---|
| geriatrics individuals with metabolic syndrome | Not described Receives: Other: survey and physical test | |
| geriatrics individuals without metabolic syndrome | Not described Receives: Other: survey and physical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 minute
Secondary outcomes (5)
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.
Measured: 5 minute
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.
Measured: 2 minute
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.
Measured: 2 minute
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.
Measured: 5 minute
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.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start30 Jan 2024
- Primary completion15 Apr 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Kemal Gürbüz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253819
- Sponsor's protocol ID
- Gurbuz05
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Functions, Exercise Endurance and Functional Capacity in Geriatric Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06253819
- Acronym / sponsor ID
- Gurbuz05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| geriatrics individuals with metabolic syndrome | – | Other: survey and physical test |
| geriatrics individuals without metabolic syndrome | – | Other: survey and physical test |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Mini Mental Status Scale less than 24
- Presence of orthopaedic condition preventing physical activity
- Having undergone cardiovascular surgery
- Having a pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey and physical test6 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 | Other | geriatrics individuals with metabolic syndrome, geriatrics individuals without metabolic syndrome |
Primary outcome
functional status
Time frame: 3 minute
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.
balance and function
Time frame: 2 minute
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.
5 secondary outcomes
respiratory function
Time frame: 5 minute
respiratory muscle strenght
Time frame: 2 minute
Quality of life, questionnaire questions on quality of life
Time frame: 2 minute
pain level
Time frame: 5 minute
functional exercise capacity
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Respiratory Disease, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional status (time frame: 3 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.