HypertensionNCT06083376
Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives
A study testing Spinal Stabilization Exercise and physical activity counseling in people with Hypertension, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Spinal Stabilization Exercise and physical activity counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 29 Oct 2024
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karamanoğlu Mehmetbey University
Merkez, Karaman
About this study
Official title: Effect of Telerehabilitation-based Spinal Stabilization Exercises on Epicardial Adipose Tissue and Exercises Capacity in Individuals With Hypertension
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.
- Conditions
- Hypertension
- Being tested
- Spinal Stabilization Exercise, physical activity counseling
- Keywords
- Epicardial adipose tissue, Hypertension, Exercises Capacity, Telerehabilitation, spinal stabilisation exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Stabilization ExerciseOther
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.
physical activity counselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | Not described Receives: Other: Spinal Stabilization Exercise |
| control group | Active comparator | Not described Receives: Other: physical activity counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
Secondary outcomes (12)
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
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.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Dec 2023
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Emine Tunç Süygün, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083376
- Sponsor's protocol ID
- KMU-TUNCSUYGUN-003
- Status last verified
- Apr 2025
- First submitted
- 5 Oct 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tunc Suygun E, Suygun H, Senalp ZE, Vardar Yagli N. The effect of telerehabilitation-based core stabilization exercises on epicardial fat tissue and exercise capacity in hypertensives. Disabil Rehabil. 2026 Jun;48(11):3458-3469. doi: 10.1080/09638288.2025.2593190. Epub 2025 Nov 24.
PubMed 41283774
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telerehabilitation-based Spinal Stabilization Exercises on Epicardial Adipose Tissue and Exercises Capacity in Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT06083376
- Acronym / sponsor ID
- KMU-TUNCSUYGUN-003
- Conditions
- Hypertension
- Keywords
- Epicardial adipose tissue, Hypertension, Exercises Capacity, Telerehabilitation, spinal stabilisation exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 16 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Spinal Stabilization Exercise |
| control group | Active comparator | Other: physical activity counseling |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Severe valvular disease
- Having heart failure
- Having cardiomyopathy
- Myocardial infarction at least 6 months ago
- Stable or unstable angina pectoris
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 |
|---|---|---|
| Spinal Stabilization ExerciseSpinal 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. | Other | exercise group |
| physical activity counselingControl 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. | Other | control group |
Primary outcome
Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
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
Time frame: baseline and 8 weeks
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.
12 secondary outcomes
Change in blood pressure after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Change in heart rate after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Change in Evaluation of Spinal Stabilisation Endurance after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Stabilisation Strength of Deep Spinal Muscles after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of functional mobility and balance after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Quality of Life after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of healthy life profile after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Activity of Daily Living after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Activity of Physical Activity after 8 weeks-24 sessions of exercise
Time frame: baseline and 8 weeks
Evaluation of Self-Efficacy and Self-Management after 8 weeks-24 sessions of exercise
Time frame: baseline and 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 2 May 2025.
- Derived from this study: PubMed 41283774Tunc Suygun E, Suygun H, Senalp ZE, Vardar Yagli N. The effect of telerehabilitation-based core stabilization exercises on epicardial fat tissue and exercise capacity in hypertensives. Disabil Rehabil. 2026 Jun;48(11):3458-3469. doi: 10.1080/09638288.2025.2593190. Epub 2025 Nov 24.
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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?
A study testing Spinal Stabilization Exercise and physical activity counseling in people with Hypertension, run by Karamanoğlu Mehmetbey 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 13 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 2 May 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?
Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise (time frame: baseline and 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06083376, which also lists 1 linked publication.
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 2 May 2025.