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Exercise Training and Respiratory Muscle Training in Individuals With Metabolic Syndrome(METS) (METS)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
inspiratory muscle training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, inspiratory muscle training, high intensity interval training, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HIIT with a supervisor

Hiit and respiratory muscle training with a supervisor

control group

Arm Description

These individuals will be given HIIT training on the treadmill, accompanied by a physiotherapist, 3 days a week for 8 weeks.

HIIT program and respiratory muscle training will be applied to these individuals 3 days a week for 8 weeks.

The importance of physical activity will be explained and appropriate physical activity recommendations will be made.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

functional capacity
Functional capacity will be evaluated with a 1 minute sit-stand test. The number of sit-ups will be noted.
flexibility
flexibility will be evaluated with the functional reach test and sit and reach test. Results will be recorded in cm.
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.
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.
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.
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.
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.
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.
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.
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 %.
spot urinalysis
In the urine analysis, albumin, protein and creatinine values will be recorded as mg/dl.
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) .
body weight
Body Composition Scale will be used for body composition measurement . Body weight will be recorded in kilogram(kg).
Body mass index(BMI)
Weight and height will be combined to report BMI in kg/m^2.
Body fat ratio
Body fat ratio will be measured with 'MI Scala 2'. It will be recorded in %.
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.
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).

Full Information

First Posted
March 6, 2022
Last Updated
August 11, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05413434
Brief Title
Exercise Training and Respiratory Muscle Training in Individuals With Metabolic Syndrome(METS)
Acronym
METS
Official Title
The Effects of Exercise Training and Respiratory Muscle Training on Physical Fitness, Pulmonary Functions and METS Parameters in Individuals With METS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, inspiratory muscle training, high intensity interval training, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
Participant
Masking Description
The physician who referred patients to the study and the participants were blind to the study.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT with a supervisor
Arm Type
Experimental
Arm Description
These individuals will be given HIIT training on the treadmill, accompanied by a physiotherapist, 3 days a week for 8 weeks.
Arm Title
Hiit and respiratory muscle training with a supervisor
Arm Type
Experimental
Arm Description
HIIT program and respiratory muscle training will be applied to these individuals 3 days a week for 8 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The importance of physical activity will be explained and appropriate physical activity recommendations will be made.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
high-intensity interval training will be performed on the treadmill.
Intervention Type
Device
Intervention Name(s)
inspiratory muscle training
Intervention Description
Respiratory muscle strength exercise will be performed with the respiratory muscle strengthening device 'POWERbreathe Classic Light Resistance'.
Primary Outcome Measure Information:
Title
VO2max
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
functional capacity
Description
Functional capacity will be evaluated with a 1 minute sit-stand test. The number of sit-ups will be noted.
Time Frame
8 weeks
Title
flexibility
Description
flexibility will be evaluated with the functional reach test and sit and reach test. Results will be recorded in cm.
Time Frame
8 weeks
Title
systolic and diastolic blood pressure
Description
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.
Time Frame
8 weeks
Title
C-Reactive Protein (CRP)
Description
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.
Time Frame
8 weeks
Title
Low Density Lipoprotein Cholesterol (LDL-C)
Description
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.
Time Frame
8 weeks
Title
High Density Lipoprotein Cholesterol (HDL-C)
Description
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.
Time Frame
8 weeks
Title
Total Cholesterol
Description
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.
Time Frame
8 weeks
Title
Triglycerides(TC)
Description
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.
Time Frame
8 weeks
Title
Fasting blood glucose
Description
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.
Time Frame
8 weeks
Title
Hemoglobin A1c(HbA1c)
Description
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 %.
Time Frame
8 weeks
Title
spot urinalysis
Description
In the urine analysis, albumin, protein and creatinine values will be recorded as mg/dl.
Time Frame
8 weeks
Title
height
Description
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) .
Time Frame
8 weeks
Title
body weight
Description
Body Composition Scale will be used for body composition measurement . Body weight will be recorded in kilogram(kg).
Time Frame
8 weeks
Title
Body mass index(BMI)
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
8 weeks
Title
Body fat ratio
Description
Body fat ratio will be measured with 'MI Scala 2'. It will be recorded in %.
Time Frame
8 weeks
Title
Respiratory function
Description
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.
Time Frame
8 weeks
Title
respiratory muscle strength
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
oğuz uyaroglu, PHD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol and data analysis will be shared with other researchers.

Learn more about this trial

Exercise Training and Respiratory Muscle Training in Individuals With Metabolic Syndrome(METS)

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