Metabolic SyndromeMETSNCT05413434
Exercise Training and Respiratory Muscle Training in Individuals With Metabolic Syndrome(METS)
A study testing exercise and inspiratory muscle training in people with Metabolic Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted on individuals with Metabolic Syndrome. There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), Triglyceride (TG), systolic and diastolic blood pressure (SBP-DBP), and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- exercise and inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Apr 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- METS will be defined according to the National Adult Cholesterol Education Program Adult Treatment Panel III. Patients with at least three or more of the following five characteristics will be included in the study:
- Waist circumference ≥102 cm for men or ≥88 cm for women;
- blood pressure above 130/85 mmHg;
- Fasting blood glucose (FG) ≥100 mg/dL;
- Blood TG ≥150 mg/dL; and
- HDL-C < 40 mg/dL for men and < 50 mg/dL for women.
Show all 10Show fewer
- Not participating in any physical activity program (≤2 physical activity days per week ≤ 30 minutes per session).
- 18 -65 years
- to walk and cooperate
- to participate in the research
Who cannot join
- heart failure,
- pectoris,
- of myocardial infarction or stroke in less than one year,
- hypertension,
- cardiovascular or kidney disease,
- with peripheral vascular disease and any disease associated with exercise intolerance will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Training and Respiratory Muscle Training on Physical Fitness, Pulmonary Functions and METS Parameters in Individuals With METS
The study will be conducted on individuals with Metabolic Syndrome. There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), Triglyceride (TG), systolic and diastolic blood pressure (SBP-DBP), and cardiorespiratory fitness on METS parameters. However, although the beneficial effects of physical activity are known, only half of the population adheres to the 150 minutes of moderate-intensity physical activity per week recommendation. High-intensity interval training (HIIT) is a type of training that uses near-maximal intensities in short-term sessions. HIIT has been used to improve compliance because it requires less time to treat patients with cardiometabolic disease. Compared to continuous aerobic exercise, this type of training has been shown to be an effective alternative for improving maximum oxygen consumption (VO2 max), blood pressure, heart function, glucose and lipid metabolism, and markers of oxidative stress and inflammation. In the literature, HIIT has been studied in patients with METS and has been shown to be effective. In addition, a study showed that seven-day respiratory muscle training was also effective on METS parameters, but there is no study showing the long-term effects of respiratory muscle training in this patient group. Therefore, in our study, researchers aimed to show the effects of respiratory muscle training given with HIIT on METS parameters.
Read the detailed description
Metabolic syndrome (METS) is a systemic endocrinopathy characterized by the presence of risk factors such as abdominal obesity, glucose intolerance or diabetes mellitus, atherogenic dyslipidemia, hypertension, and a persistent proinflammatory profile. According to the International Diabetes Federation (IDF) definition of METS, almost 20-25% of the adult world population has METS, and people with METS are at risk of heart attack, stroke, type 2 diabetes (T2D), all-cause and cardiovascular death (approximately three times higher). In addition, modifiable risk factors such as physical inactivity, diet, and sedentary behavior have all been associated with increased prevalence of METS. Increasing incidence of METS, increase in morbidity and mortality necessitated the implementation of preventive strategies and the implementation of pharmacological and non-pharmacological treatments.
Studies in the literature have shown that vagal tone decreases and sympathetic tone increases in patients with METS. At the same time, impaired baroreflex sensitivity and decreased heart rate variability are observed in these patients. Changes in autonomic modulation cause the release of some bioactive molecules by affecting the endocrine and immune systems. In this case, increased sympathetic autonomic tone creates a cardiometabolic risk. In adults with METS, autonomic dysfunction appears to be more prominent in women than in men. Autonomic functions are impaired due to changes such as loss of lean body mass, increase in fat mass, increase in body mass, redistribution of fat from the periphery to the middle parts of the body, especially in postmenopausal women. As a result, increased blood pressure, impaired endothelial function, decreased glucose tolerance, and atherogenic changes in lipid and coagulation profiles can be observed. This increases the incidence of METS in postmenopausal women. Therefore, strategies to reduce the risk of metabolic syndrome have often been studied on women in the literature, and there is a need for studies involving men and new strategies.
Physical activity and exercise training are recommended as key prescriptions for the prevention and treatment of METS and low-grade chronic inflammation . Increase in physical exercise has been recommended for the prevention and primary treatment of cardiovascular disease (CVD) and METS because of the cardioprotective benefits associated with improved cardiorespiratory fitness (CRF). There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), TG, systolic and diastolic blood pressure (SBP-DBP), and cardiorespiratory fitness on METS parameters . However, although the beneficial effects of physical activity are known, only half of the population adheres to the 150 minutes of moderate-intensity physical activity per week recommendation. It has been shown that one of the main barriers to reaping health benefits and being more active is "lack of time". High-intensity interval training (HIIT) is a type of training that uses near-maximal intensities in short-term sessions. HIIT has been used to improve compliance because it requires less time to treat patients with cardiometabolic disease. Compared to continuous aerobic exercise, this type of training is an effective alternative to improve maximum oxygen consumption (VO2max), blood pressure, heart function, glucose and lipid metabolism, and markers of oxidative stress and inflammation . However, it has been seen that there are not enough studies on HIIT effectiveness on METS parameters in the literature. Therefore, researchers aimed to show the effects of HIIT training applied together with respiratory muscle training on METS parameters in patients with METS.
It has shown the beneficial effects of exercise training as well as inspiratory muscle training (IME) on autonomic function in patients with hypertension and heart disease . In a study, it was shown that 7-day inspiratory muscle training improved respiratory muscle functions and cardiac autonomic functions in postmenopausal women . As a result of this study, inspiratory muscle training has been proposed as a nonpharmacological strategy to improve autonomic modulation and reduce risk factors in individuals with METS, but further studies are required to confirm the long-term effects or effects of inspiratory muscle training in addition to classical exercise training protocols such as aerobic, resistance or combined training. are needed.
In a study conducted in healthy and middle-aged men and postmenopausal women in 2021, it was proven that high resistance inspiratory muscle strength training can improve blood pressure control and vascular endothelial function, and reduce the risk of cardiovascular disease and other clinical disorders. In this study, researchers presented the first evidence that inspiratory muscle strength training increases NO bioavailability, decreases systemic inflammation, and causes potentially beneficial changes in the plasma metabolome by increasing endothelial NO synthase activation and decreasing oxidative stress. In conclusion, it has been shown that inspiratory muscle strength training can be used as a promising lifestyle intervention to improve cardiovascular function and reduce the risk of other clinical disorders .
Since the long-term effects of respiratory muscle training in individuals with METS have not been examined in the literature; researchers planned this study to examine the effects of inspiratory muscle strength training added to aerobic exercise training (HIIT) on physical fitness, respiratory functions and METS parameters in individuals with METS.
- Conditions
- Metabolic Syndrome
- Being tested
- exercise, inspiratory muscle training
- Keywords
- metabolic syndrome, inspiratory muscle training, high intensity interval training, exercise
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
high-intensity interval training will be performed on the treadmill.
inspiratory muscle trainingDevice
Respiratory muscle strength exercise will be performed with the respiratory muscle strengthening device 'POWERbreathe Classic Light Resistance'.
| Study group | Role | What they receive |
|---|---|---|
| HIIT with a supervisor | Experimental | These individuals will be given HIIT training on the treadmill, accompanied by a physiotherapist, 3 days a week for 8 weeks. Receives: Other: exercise |
| Hiit and respiratory muscle training with a supervisor | Experimental | HIIT program and respiratory muscle training will be applied to these individuals 3 days a week for 8 weeks. Receives: Other: exercise; Device: inspiratory muscle training |
| control group | No intervention | The importance of physical activity will be explained and appropriate physical activity recommendations will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Cardiorespiratory fitness will be performed using a cardiopulmonary exercise test (CPET) with a treadmill, using the measurement method (breath by breath) with each breath. The modified Bruce protocol will be applied.VO2max will be recorded in ml/kg/min.
Measured: 8 weeks
Secondary outcomes (17)
functional capacity
Functional capacity will be evaluated with a 1 minute sit-stand test. The number of sit-ups will be noted.
Measured: 8 weeks
flexibility
flexibility will be evaluated with the functional reach test and sit and reach test. Results will be recorded in cm.
Measured: 8 weeks
systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured using a digital sphygmomanometer (BP710, Omron, Tokyo, Japan) and results will be recorded in millimeters of mercury (mmHg). After the participants rest for 5 minutes in a sitting position, two measurements will be taken with an interval of 1 minute. The average of the two measurements will be recorded in mmHg.
Measured: 8 weeks
C-Reactive Protein (CRP)
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. CRP will be recorded in mg/dl.
Measured: 8 weeks
Low Density Lipoprotein Cholesterol (LDL-C)
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. LDL-C will be recorded in mg/dl.
Measured: 8 weeks
High Density Lipoprotein Cholesterol (HDL-C)
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. HDL-C will be recorded in mg/dl.
Measured: 8 weeks
Total Cholesterol
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. Total Cholesterol will be recorded in mg/dl.
Measured: 8 weeks
Triglycerides(TC)
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. TC will be recorded in mg/dl.
Measured: 8 weeks
Fasting blood glucose
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. Fasting blood glucose will be recorded in mg/dl.
Measured: 8 weeks
Hemoglobin A1c(HbA1c)
Fasting blood samples will be taken from the patients before and after the 8-week training, after 12 hours of fasting, at Hacettepe University Hospital, Department of Internal Medicine, General Internal Medicine. It will be held in the morning, 48 hours after the end of the training. HbA1c will be described in %.
Measured: 8 weeks
spot urinalysis
In the urine analysis, albumin, protein and creatinine values will be recorded as mg/dl.
Measured: 8 weeks
height
A non-flexible and sensitive up to 0.1 cm tape measure will be used to measure the height of the participants.Height will be recorded in centimeter(cm) .
Measured: 8 weeks
body weight
Body Composition Scale will be used for body composition measurement . Body weight will be recorded in kilogram(kg).
Measured: 8 weeks
Body mass index(BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: 8 weeks
Body fat ratio
Body fat ratio will be measured with 'MI Scala 2'. It will be recorded in %.
Measured: 8 weeks
Respiratory function
Pulmonary function test parameters will be performed with a portable spirometer device in sitting position, taking into account the criteria of the American Thoracic Society and the European Respiratory Society. Forced Vital Capacity (FVC %), Forced expiratory volume (FEV1%) ,Peak expiratory flow (PEF %), forced mid-expiratory flow (FEF25-75%) will be recorded.
Measured: 8 weeks
respiratory muscle strength
Respiratory muscle strength will be evaluated with a portable intraoral pressure gauge ('Micro Medical( MicroRPM), Rochester, UK). Maximal inspiratory pressure and maximal expiratory pressure values will be recorded in centimeters of water(cmH2O).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Apr 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal GÜNGÖR, Hacettepe University
- Investigators
- oğuz uyaroglu, PHD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413434
- Sponsor's protocol ID
- HacettepeKPR
- Acronym
- METS
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol and data analysis will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training and Respiratory Muscle Training on Physical Fitness, Pulmonary Functions and METS Parameters in Individuals With METS
- ClinicalTrials.gov ID
- NCT05413434
- Acronym / sponsor ID
- METS / HacettepeKPR
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, inspiratory muscle training, high intensity interval training, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 10 Jun 2022 (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.
The study will be conducted on individuals with Metabolic Syndrome. There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), Triglyceride (TG), systolic and diastolic blood pressure (SBP-DBP), and cardiorespiratory fitness on METS parameters. However, although the beneficial effects of physical activity are known, only half of the population adheres to the 150 minutes of moderate-intensity physical activity per week recommendation. High-intensity interval training (HIIT) is a type of training that uses near-maximal intensities in short-term sessions. HIIT has been used to improve compliance because it requires less time to treat patients with cardiometabolic disease. Compared to continuous aerobic exercise, this type of training has been shown to be an effective alternative for improving maximum oxygen consumption (VO2 max), blood pressure, heart function, glucose and lipid metabolism, and markers of oxidative stress and inflammation. In the literature, HIIT has been studied in patients with METS and has been shown to be effective. In addition, a study showed that seven-day respiratory muscle training was also effective on METS parameters, but there is no study showing the long-term effects of respiratory muscle training in this patient group. Therefore, in our study, researchers aimed to show the effects of respiratory muscle training given with HIIT on METS parameters.
Detailed description
Metabolic syndrome (METS) is a systemic endocrinopathy characterized by the presence of risk factors such as abdominal obesity, glucose intolerance or diabetes mellitus, atherogenic dyslipidemia, hypertension, and a persistent proinflammatory profile. According to the International Diabetes Federation (IDF) definition of METS, almost 20-25% of the adult world population has METS, and people with METS are at risk of heart attack, stroke, type 2 diabetes (T2D), all-cause and cardiovascular death (approximately three times higher). In addition, modifiable risk factors such as physical inactivity, diet, and sedentary behavior have all been associated with increased prevalence of METS. Increasing incidence of METS, increase in morbidity and mortality necessitated the implementation of preventive strategies and the implementation of pharmacological and non-pharmacological treatments.
Studies in the literature have shown that vagal tone decreases and sympathetic tone increases in patients with METS. At the same time, impaired baroreflex sensitivity and decreased heart rate variability are observed in these patients. Changes in autonomic modulation cause the release of some bioactive molecules by affecting the endocrine and immune systems. In this case, increased sympathetic autonomic tone creates a cardiometabolic risk. In adults with METS, autonomic dysfunction appears to be more prominent in women than in men. Autonomic functions are impaired due to changes such as loss of lean body mass, increase in fat mass, increase in body mass, redistribution of fat from the periphery to the middle parts of the body, especially in postmenopausal women. As a result, increased blood pressure, impaired endothelial function, decreased glucose tolerance, and atherogenic changes in lipid and coagulation profiles can be observed. This increases the incidence of METS in postmenopausal women. Therefore, strategies to reduce the risk of metabolic syndrome have often been studied on women in the literature, and there is a need for studies involving men and new strategies.
Physical activity and exercise training are recommended as key prescriptions for the prevention and treatment of METS and low-grade chronic inflammation . Increase in physical exercise has been recommended for the prevention and primary treatment of cardiovascular disease (CVD) and METS because of the cardioprotective benefits associated with improved cardiorespiratory fitness (CRF). There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), TG, systolic and diastolic blood pressure (SBP-DBP), and cardiorespiratory fitness on METS parameters . However, although the beneficial effects of physical activity are known, only half of the population adheres to the 150 minutes of moderate-intensity physical activity per week recommendation. It has been shown that one of the main barriers to reaping health benefits and being more active is "lack of time". High-intensity interval training (HIIT) is a type of training that uses near-maximal intensities in short-term sessions. HIIT has been used to improve compliance because it requires less time to treat patients with cardiometabolic disease. Compared to continuous aerobic exercise, this type of training is an effective alternative to improve maximum oxygen consumption (VO2max), blood pressure, heart function, glucose and lipid metabolism, and markers of oxidative stress and inflammation . However, it has been seen that there are not enough studies on HIIT effectiveness on METS parameters in the literature. Therefore, researchers aimed to show the effects of HIIT training applied together with respiratory muscle training on METS parameters in patients with METS.
It has shown the beneficial effects of exercise training as well as inspiratory muscle training (IME) on autonomic function in patients with hypertension and heart disease . In a study, it was shown that 7-day inspiratory muscle training improved respiratory muscle functions and cardiac autonomic functions in postmenopausal women . As a result of this study, inspiratory muscle training has been proposed as a nonpharmacological strategy to improve autonomic modulation and reduce risk factors in individuals with METS, but further studies are required to confirm the long-term effects or effects of inspiratory muscle training in addition to classical exercise training protocols such as aerobic, resistance or combined training. are needed.
In a study conducted in healthy and middle-aged men and postmenopausal women in 2021, it was proven that high resistance inspiratory muscle strength training can improve blood pressure control and vascular endothelial function, and reduce the risk of cardiovascular disease and other clinical disorders. In this study, researchers presented the first evidence that inspiratory muscle strength training increases NO bioavailability, decreases systemic inflammation, and causes potentially beneficial changes in the plasma metabolome by increasing endothelial NO synthase activation and decreasing oxidative stress. In conclusion, it has been shown that inspiratory muscle strength training can be used as a promising lifestyle intervention to improve cardiovascular function and reduce the risk of other clinical disorders .
Since the long-term effects of respiratory muscle training in individuals with METS have not been examined in the literature; researchers planned this study to examine the effects of inspiratory muscle strength training added to aerobic exercise training (HIIT) on physical fitness, respiratory functions and METS parameters in individuals with METS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| HIIT with a supervisor | Experimental | Other: exerciseThese individuals will be given HIIT training on the treadmill, accompanied by a physiotherapist, 3 days a week for 8 weeks. |
| Hiit and respiratory muscle training with a supervisor | Experimental | Other: exercise, Device: inspiratory muscle trainingHIIT program and respiratory muscle training will be applied to these individuals 3 days a week for 8 weeks. |
| control group | No intervention | –The importance of physical activity will be explained and appropriate physical activity recommendations will be made. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- METS will be defined according to the National Adult Cholesterol Education Program Adult Treatment Panel III. Patients with at least three or more of the following five characteristics will be included in the study:
- Waist circumference ≥102 cm for men or ≥88 cm for women;
- blood pressure above 130/85 mmHg;
- Fasting blood glucose (FG) ≥100 mg/dL;
- Blood TG ≥150 mg/dL; and
Key exclusion criteria (6 listed)
- heart failure,
- pectoris,
- of myocardial infarction or stroke in less than one year,
- hypertension,
- cardiovascular or kidney disease,
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 |
|---|---|---|
| exercisehigh-intensity interval training will be performed on the treadmill. | Other | HIIT with a supervisor, Hiit and respiratory muscle training with a supervisor |
| inspiratory muscle trainingRespiratory muscle strength exercise will be performed with the respiratory muscle strengthening device 'POWERbreathe Classic Light Resistance'. | Device | Hiit and respiratory muscle training with a supervisor |
Primary outcome
VO2max
Time frame: 8 weeks
Cardiorespiratory fitness will be performed using a cardiopulmonary exercise test (CPET) with a treadmill, using the measurement method (breath by breath) with each breath. The modified Bruce protocol will be applied.VO2max will be recorded in ml/kg/min.
17 secondary outcomes
functional capacity
Time frame: 8 weeks
flexibility
Time frame: 8 weeks
systolic and diastolic blood pressure
Time frame: 8 weeks
C-Reactive Protein (CRP)
Time frame: 8 weeks
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 8 weeks
High Density Lipoprotein Cholesterol (HDL-C)
Time frame: 8 weeks
Total Cholesterol
Time frame: 8 weeks
Triglycerides(TC)
Time frame: 8 weeks
Fasting blood glucose
Time frame: 8 weeks
Hemoglobin A1c(HbA1c)
Time frame: 8 weeks
spot urinalysis
Time frame: 8 weeks
height
Time frame: 8 weeks
body weight
Time frame: 8 weeks
Body mass index(BMI)
Time frame: 8 weeks
Body fat ratio
Time frame: 8 weeks
Respiratory function
Time frame: 8 weeks
respiratory muscle strength
Time frame: 8 weeks
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 15 Aug 2023.
- Individual participant dataSharing planned: No. Study protocol and data analysis will be shared with other researchers.
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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.
oğuz uyaroglu, PHD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and inspiratory muscle training in people with Metabolic Syndrome, run by Hacettepe 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 10 inclusion and 6 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 15 Aug 2023. 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?
VO2max (time frame: 8 weeks). 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 15 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.