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Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal Stabilization Exercise
physical activity counseling
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Epicardial adipose tissue, Hypertension, Exercises Capacity, Telerehabilitation, spinal stabilisation exercise

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being followed up with Hypertension for at least 6 months Volunteering to participate in the study Speaking Turkish Being literate Not having participated in any structured exercise programme for at least 6 months Exclusion Criteria: Severe valvular disease Having heart failure Having cardiomyopathy Myocardial infarction at least 6 months ago Stable or unstable angina pectoris Left ventricular ejection fraction below 40 Presence of peripheral artery disease History of deep vein thrombosis, pulmonary embolism or stroke in the past Chronic kidney disease Having thyroid diseases Active infectious or inflammatory disease Body Mass Index >40 kg/m2 Having a serious psychiatric illness such as panic disorder or major depression

Sites / Locations

  • Karamanoğlu Mehmetbey University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

exercise group

control group

Arm Description

Outcomes

Primary Outcome Measures

Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise
All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole.
Change in exercises capacity after 8 weeks-24 sessions of exercise
The six-minute walk test (6MWT) will be administered to all participants twice on the same day, half an hour apart. Patients will rest for 10 minutes before the test is performed. Subjects will be asked to walk as fast as possible at their own walking speed for 6 minutes in a 30-meter straight corridor. Every minute during the test, standard phrases will be used to encourage the patient. At the end of the test, 6 minutes walking distance will be recorded. There is no minimum or maximum value as it depends on the person's performance. Longer walking distance indicates better functional capacity.

Secondary Outcome Measures

Change in blood pressure after 8 weeks-24 sessions of exercise
Blood pressure and heart rate will be measured with a calibrated digital sphygmomanometer from the calibration unit. Participants will have their blood pressure measured in the morning after taking their current blood pressure medication. Participants will rest in a sitting position for 5 minutes before the measurement. The average of the two SDB and BP measurements will be recorded.
Change in heart rate after 8 weeks-24 sessions of exercise
Heart rate will be measured with a calibrated digital sphygmomanometer from the calibration unit. Participants will have their blood pressure measured in the morning after taking their current blood pressure medication. Participants will rest in a sitting position for 5 minutes before the measurement. The average of the two SDB and BP measurements will be recorded.
Change in Evaluation of Spinal Stabilisation Endurance after 8 weeks-24 sessions of exercise
The Bridge Building Test will be used to assess spinal stabilisation endurance. Participants were asked to lift their hips off the bed in the supine position and maintain the position without breaking the position. The time they maintain the position will be recorded in seconds.
Evaluation of Stabilisation Strength of Deep Spinal Muscles after 8 weeks-24 sessions of exercise
Stabilisation ability of deep spinal muscles will be evaluated by using "The Stabilizer Pressure Biofeedback Unit" (BGU). The BGU is a device designed by physiotherapists that shows the pressure change in a cell that is filled with air and pressurised. The stabiliser is used to monitor, measure and provide feedback on the movement of the relevant body segment. During the test, participants are asked to lie face down with their head turned to one side. The three-chamber pressure cell of the device is placed in the lower part of the abdominal region and in the centre of the spina iliaca anterior superior. Once the pressure of the manometer is inflated to 70 mmHg, the participants are asked to pull the abdominal wall inwards without any spinal or pelvic movement, as previously taught. Pressure readings for measurement are taken 3 times in succession for 10 seconds.
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
5 repetition sit and stand test (5TOKT): It is a performance test in which dynamic balance is evaluated by recording the performance of the individuals to sit and stand on a chair 5 times serially in terms of time. To measure the 5TOKT time, the participants are asked to sit on a chair that is not fixed to the floor, without armrests, 45 cm high, with a flat back and a hard floor, with their backs touching the back of the chair and their hands crossed in front of their torso. The participants sit on and off the chair 5 times as fast as they can following the 'Go' command of the assessor
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
Hand grip strength will be evaluated with a hand dynamometer (Saehan hydraulic dynamometer). The measurement will be made in the dominant hand. Grip strength measurements for the dominant hand of the volunteers will be taken three times and the highest value in kilograms (kg) will be recorded for statistical evaluation. There will be a break of at least one minute between each trial.
Evaluation of functional mobility and balance after 8 weeks-24 sessions of exercise
The Time Up and Go Test (TUG) will be used to measure functional mobility and balance in individuals. It is a practical method that does not require equipment. During the test, the participant sits in the chair at the beginning, gets up from the chair with the start command, goes to the place marked 3 m ahead, returns and sits back in the chair. The time is recorded in seconds
Evaluation of Quality of Life after 8 weeks-24 sessions of exercise
The EQ-5D Quality of Life Scale will be used to assess the quality of life of the participants. It consists of five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers to each dimension have 3 options: no problem, some problem and major problem. The index values of the scale are calculated on the computer using an excel format prepared by the Euro Quality of Life group based on formulae calculated from different population samples. The answers obtained from these patients are placed on this programme. It is the calculation of individual-specific index values ranging between 0 and 1. In index scores, a value of 0 indicates death and a value of 1 indicates perfect health. The scale developers did not specify minimum and maximum values.
Evaluation of healthy life profile after 8 weeks-24 sessions of exercise
Healthy life profile will be evaluated with the Healthy Lifestyle Behaviours Scale. The scale was developed by Walker et al. The scale was revised in 1996 and named as Healthy Lifestyle Behaviours Scale-II. The Turkish validity and reliability study was conducted by Bahar et al. in 2008. The scale has 52 items and consists of six factors. These are health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. The scale rating is in 4-point Likert type. Never (1), sometimes (2), frequently (3) and regularly (4) are accepted. The lowest score that can be obtained from the whole scale is 52 and the highest score is 208.
Evaluation of Activity of Daily Living after 8 weeks-24 sessions of exercise
Nottingham Extended Activities of Daily Living (NADL) for assessing GYA Index (NGGYA) will be used. It consists of 22 questions. All questions are answered on a scale from 0 to 3 points. It has 4 subscales; movement, in the kitchen, housework, leisure activities. The sum of these 4 subscales gives the total score. The highest possible score is 66. Turkish validity and reliability study was conducted by Şahin et al.
Evaluation of Activity of Physical Activity after 8 weeks-24 sessions of exercise
Physical activity level was evaluated with the Turkish version of the International Physical Activity Questionnaire-7, whose reliability and validity. The International Physical Activity Questionnaire-7 is a seven-item questionnaire that assesses severe physical activity (duration: min and frequency: day), moderate physical activity (duration: min and frequency: day), and walking time of at least 10 minutes (frequency: day) over the previous seven days. The metabolic equivalent of task (MET) corresponding to the basal metabolic rate is converted from severe and moderate activity and walking periods, and the overall physical activity score (MET- min/week) is determined. Higher scores indicate higher levels of physical activity. There is no minimum or maximum value since it depends on performance in daily life.
Evaluation of Self-Efficacy and Self-Management after 8 weeks-24 sessions of exercise
Heart Health Self-Efficacy and Self-Management Scale was developed by Maria Mares et al. It is a 12-item scale that can evaluate the concepts of self-efficacy and self-effectiveness, which are prominent in disease management. Both English and Arabic languages were used in the scale development study. Turkish adaptation study (Karamanoğlu Mehmetbey University Faculty of Medicine Ethics Committee Decision No 04-202l/04) Süygün et al. A minimum of 0 and a maximum of 48 points can be obtained. Higher scores indicate better self-efficacy and self-management.

Full Information

First Posted
October 5, 2023
Last Updated
October 13, 2023
Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06083376
Brief Title
Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives
Official Title
Effect of Telerehabilitation-based Spinal Stabilization Exercises on Epicardial Adipose Tissue and Exercises Capacity in Individuals With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
August 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It has been suggested that Epicardial Adipose Tissue (EAT) may be an adjunctive marker to classical risk factors for the presence and severity of coronary artery disease. EAT thickness is also associated with MetS and hypertension, high levels of low-density lipoprotein cholesterol and insulin resistance.Studies have shown that moderate-intensity and high-intensity aerobic exercise and resistance exercise training reduce EAT. However, aerobic and resistance exercises may be found challenging and demanding by individuals and in most cases, high or moderate intensity exercise may be considered difficult. In a study conducted in physically inactive individuals, it was concluded that there was a significant increase in heart rate and BP following spinal stabilisation exercises performed 4 days a week for a total of 8 sessions for 2 weeks, but the increase in these cardiac parameters would tend to decrease following regular exercise. In the current literature, there is no study evaluating the effect of spinal stabilisation exercise on EAT thickness, exercise capacity and cardiovascular parameters in individuals with HT. Barriers to access to healthcare services such as distance, time and cost can be overcome with technology. COVID-19 has accelerated the transition of many physiotherapy services to telerehabilitation. Evidence has shown that telerehabilitation is an effective delivery model for providing face-to-face physiotherapy services with equal or even superior outcomes, especially in musculoskeletal treatment. The aim of this study was to determine the effect of spinal stabilisation exercise with telerehabilitation on EAT and exercise capacity in individuals with HT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Epicardial adipose tissue, Hypertension, Exercises Capacity, Telerehabilitation, spinal stabilisation exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Spinal Stabilization Exercise
Intervention Description
Spinal stability exercises are commonly used isometric and isotonic exercises. A spinal stabilization exercise training program will be applied to the exercise group participants using the telerehabilitation method (simultaneous connection) 3 days a week for 8 weeks and a total of 24 sessions.
Intervention Type
Other
Intervention Name(s)
physical activity counseling
Intervention Description
Control group participants will first be given initial evaluations and verbal physical activity recommendations will be given. Patients will be contacted by phone at the 2nd, 4th and 6th weeks and reminded about the importance of physical activity.
Primary Outcome Measure Information:
Title
Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise
Description
All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole.
Time Frame
baseline and 8 weeks
Title
Change in exercises capacity after 8 weeks-24 sessions of exercise
Description
The six-minute walk test (6MWT) will be administered to all participants twice on the same day, half an hour apart. Patients will rest for 10 minutes before the test is performed. Subjects will be asked to walk as fast as possible at their own walking speed for 6 minutes in a 30-meter straight corridor. Every minute during the test, standard phrases will be used to encourage the patient. At the end of the test, 6 minutes walking distance will be recorded. There is no minimum or maximum value as it depends on the person's performance. Longer walking distance indicates better functional capacity.
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in blood pressure after 8 weeks-24 sessions of exercise
Description
Blood pressure and heart rate will be measured with a calibrated digital sphygmomanometer from the calibration unit. Participants will have their blood pressure measured in the morning after taking their current blood pressure medication. Participants will rest in a sitting position for 5 minutes before the measurement. The average of the two SDB and BP measurements will be recorded.
Time Frame
baseline and 8 weeks
Title
Change in heart rate after 8 weeks-24 sessions of exercise
Description
Heart rate will be measured with a calibrated digital sphygmomanometer from the calibration unit. Participants will have their blood pressure measured in the morning after taking their current blood pressure medication. Participants will rest in a sitting position for 5 minutes before the measurement. The average of the two SDB and BP measurements will be recorded.
Time Frame
baseline and 8 weeks
Title
Change in Evaluation of Spinal Stabilisation Endurance after 8 weeks-24 sessions of exercise
Description
The Bridge Building Test will be used to assess spinal stabilisation endurance. Participants were asked to lift their hips off the bed in the supine position and maintain the position without breaking the position. The time they maintain the position will be recorded in seconds.
Time Frame
baseline and 8 weeks
Title
Evaluation of Stabilisation Strength of Deep Spinal Muscles after 8 weeks-24 sessions of exercise
Description
Stabilisation ability of deep spinal muscles will be evaluated by using "The Stabilizer Pressure Biofeedback Unit" (BGU). The BGU is a device designed by physiotherapists that shows the pressure change in a cell that is filled with air and pressurised. The stabiliser is used to monitor, measure and provide feedback on the movement of the relevant body segment. During the test, participants are asked to lie face down with their head turned to one side. The three-chamber pressure cell of the device is placed in the lower part of the abdominal region and in the centre of the spina iliaca anterior superior. Once the pressure of the manometer is inflated to 70 mmHg, the participants are asked to pull the abdominal wall inwards without any spinal or pelvic movement, as previously taught. Pressure readings for measurement are taken 3 times in succession for 10 seconds.
Time Frame
baseline and 8 weeks
Title
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
Description
5 repetition sit and stand test (5TOKT): It is a performance test in which dynamic balance is evaluated by recording the performance of the individuals to sit and stand on a chair 5 times serially in terms of time. To measure the 5TOKT time, the participants are asked to sit on a chair that is not fixed to the floor, without armrests, 45 cm high, with a flat back and a hard floor, with their backs touching the back of the chair and their hands crossed in front of their torso. The participants sit on and off the chair 5 times as fast as they can following the 'Go' command of the assessor
Time Frame
baseline and 8 weeks
Title
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
Description
Hand grip strength will be evaluated with a hand dynamometer (Saehan hydraulic dynamometer). The measurement will be made in the dominant hand. Grip strength measurements for the dominant hand of the volunteers will be taken three times and the highest value in kilograms (kg) will be recorded for statistical evaluation. There will be a break of at least one minute between each trial.
Time Frame
baseline and 8 weeks
Title
Evaluation of functional mobility and balance after 8 weeks-24 sessions of exercise
Description
The Time Up and Go Test (TUG) will be used to measure functional mobility and balance in individuals. It is a practical method that does not require equipment. During the test, the participant sits in the chair at the beginning, gets up from the chair with the start command, goes to the place marked 3 m ahead, returns and sits back in the chair. The time is recorded in seconds
Time Frame
baseline and 8 weeks
Title
Evaluation of Quality of Life after 8 weeks-24 sessions of exercise
Description
The EQ-5D Quality of Life Scale will be used to assess the quality of life of the participants. It consists of five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers to each dimension have 3 options: no problem, some problem and major problem. The index values of the scale are calculated on the computer using an excel format prepared by the Euro Quality of Life group based on formulae calculated from different population samples. The answers obtained from these patients are placed on this programme. It is the calculation of individual-specific index values ranging between 0 and 1. In index scores, a value of 0 indicates death and a value of 1 indicates perfect health. The scale developers did not specify minimum and maximum values.
Time Frame
baseline and 8 weeks
Title
Evaluation of healthy life profile after 8 weeks-24 sessions of exercise
Description
Healthy life profile will be evaluated with the Healthy Lifestyle Behaviours Scale. The scale was developed by Walker et al. The scale was revised in 1996 and named as Healthy Lifestyle Behaviours Scale-II. The Turkish validity and reliability study was conducted by Bahar et al. in 2008. The scale has 52 items and consists of six factors. These are health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. The scale rating is in 4-point Likert type. Never (1), sometimes (2), frequently (3) and regularly (4) are accepted. The lowest score that can be obtained from the whole scale is 52 and the highest score is 208.
Time Frame
baseline and 8 weeks
Title
Evaluation of Activity of Daily Living after 8 weeks-24 sessions of exercise
Description
Nottingham Extended Activities of Daily Living (NADL) for assessing GYA Index (NGGYA) will be used. It consists of 22 questions. All questions are answered on a scale from 0 to 3 points. It has 4 subscales; movement, in the kitchen, housework, leisure activities. The sum of these 4 subscales gives the total score. The highest possible score is 66. Turkish validity and reliability study was conducted by Şahin et al.
Time Frame
baseline and 8 weeks
Title
Evaluation of Activity of Physical Activity after 8 weeks-24 sessions of exercise
Description
Physical activity level was evaluated with the Turkish version of the International Physical Activity Questionnaire-7, whose reliability and validity. The International Physical Activity Questionnaire-7 is a seven-item questionnaire that assesses severe physical activity (duration: min and frequency: day), moderate physical activity (duration: min and frequency: day), and walking time of at least 10 minutes (frequency: day) over the previous seven days. The metabolic equivalent of task (MET) corresponding to the basal metabolic rate is converted from severe and moderate activity and walking periods, and the overall physical activity score (MET- min/week) is determined. Higher scores indicate higher levels of physical activity. There is no minimum or maximum value since it depends on performance in daily life.
Time Frame
baseline and 8 weeks
Title
Evaluation of Self-Efficacy and Self-Management after 8 weeks-24 sessions of exercise
Description
Heart Health Self-Efficacy and Self-Management Scale was developed by Maria Mares et al. It is a 12-item scale that can evaluate the concepts of self-efficacy and self-effectiveness, which are prominent in disease management. Both English and Arabic languages were used in the scale development study. Turkish adaptation study (Karamanoğlu Mehmetbey University Faculty of Medicine Ethics Committee Decision No 04-202l/04) Süygün et al. A minimum of 0 and a maximum of 48 points can be obtained. Higher scores indicate better self-efficacy and self-management.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being followed up with Hypertension for at least 6 months Volunteering to participate in the study Speaking Turkish Being literate Not having participated in any structured exercise programme for at least 6 months Exclusion Criteria: Severe valvular disease Having heart failure Having cardiomyopathy Myocardial infarction at least 6 months ago Stable or unstable angina pectoris Left ventricular ejection fraction below 40 Presence of peripheral artery disease History of deep vein thrombosis, pulmonary embolism or stroke in the past Chronic kidney disease Having thyroid diseases Active infectious or inflammatory disease Body Mass Index >40 kg/m2 Having a serious psychiatric illness such as panic disorder or major depression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emine Tunç Süygün
Phone
05349804242
Email
fzteminetunc@gmail.com
Facility Information:
Facility Name
Karamanoğlu Mehmetbey University
City
Merkez
State/Province
Karaman
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine Tunç Süygün
Phone
05349804242

12. IPD Sharing Statement

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Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives

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