Effects of Whole Body Vibration and Resistance Exercise on Carotis Intima Media and Muscle Architecture in Hypertension

NCT05775835 | Completed

• 1 other identifier: MS2022/032
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is of great importance in the treatment of hypertension, which is expressed as a very serious disease, the prevalence of which is increasing day by day in the world and can cause many complications that are common in society. Exercise methods effective on carotid intima-media thickness, skeletal muscle architecture, and strength, which are important markers of hypertension-related organ damage, remain unclear. Strengthening exercises draw attention as an important approach in the control of hypertension. In order for strengthening exercises to be effective in the rehabilitation of hypertension, moderate and high-intensity exercises are recommended. New exercise approach strategies are gaining importance in order to enable resistance exercise training and to increase muscle mass and strength in the elderly who have a limitation for the recommended exercise intensity, in patients with hypertension, and in people with various diseases in which the cardiovascular system is affected. Whole body vibration (TVV) applications, which have no side effects reported as the current example of these exercise approaches, attract attention. Many positive effects occur on the cardiovascular system with the short-term and low-effort application of TVV exercise approaches, which are frequently used in routine rehabilitation practices. However, when the literature is examined, the effects of these exercise approaches on carotid intima-media thickness, which is one of the main markers of hypertension-related organ damage, are unclear. In addition, the effects of hypertension on quadriceps muscle architecture, which are expected to be adversely affected as a result of affecting autophagy regulation in skeletal muscle and causing decreased muscle capillarization, remain unclear. In addition, there is insufficient data on the effectiveness of strengthening exercises and TVV exercises on hemodynamic responses and quadriceps muscle strength in hypertensive patients. It will shed light on the determination of the exercise approach that is most effective on the muscle architecture, hemodynamic responses and carotid intima-media thickness of hypertensive patients and that can show these effects without overloading the cardiovascular system.

Conditions

Hypertension; Whole Body Vibration; Muscle Architecture; Carotid Intima Media Thickness

Outcome Measures

Primary Outcomes (9)

• Carotid intima media thickness

  Carotid intima-media thickness (CIMT) is an independent marker of the onset of hypertension. It is also known that there is a close relationship between carotid intima media thickness and blood pressure.Carotid artery B-Mode ultrasonography examinations in the evaluation of carotid intima-media thickness EPIQ Elite Diagnostic Ultrasound System Release 7.0.5. It will be done with L18-4 MHz linear transducer using Philips ultrasonography device.

  Change from Baseline Carotid Intima Media Thickness at 6 weeks

• Quadriceps muscle architecture-muscle thickness

  Muscle architecture including rectus femoris, vastus lateralis, vastus medialis oblique and vastus intermedius muscle thicknesses will be evaluated.Maximal muscle thickness will be measured as the distance between the superficial and deep fascia at the widest distance on transversal views.All images will be taken by the same investigator and from the same anatomical region.Muscle architecture examination will be performed using the Philips ultrasonography system.

  Change from Baseline Muscle Thickness at 6 weeks

• Quadriceps muscle architecture-pennation angle

  Muscle architecture including vastus lateralis and vastus medialis oblique pennation angles will be evaluated.Pennation angle is defined as the angle between the muscle fibers and the deep fascia of the muscle. Therefore, pennation angles will be measured on the longitudinal ultrasound image. Since the orientation of the rectus femoris and vastus intermedius fibers is almost parallel to their fascia, the angle of pennation for these muscles of the quadriceps muscle was not determined. All images will be taken by the same investigator and from the same anatomical region. Muscle architecture examination will be performed using the Philips ultrasonography system.

  Change from Baseline Pennation Angle at 6 weeks

• Quadriceps muscle architecture-muscle cross-section area

  Muscle architecture including rectus femoris, vastus lateralis, vastus medialis oblique and vastus intermedius muscle cross-section areas will be evaluated.Muscle cross-sectional area measurement will be calculated by drawing the boundaries of the muscle through a program in the ultrasound device. All images will be taken by the same investigator and from the same anatomical region. Muscle architecture examination will be performed using the Philips ultrasonography system.

  Change from Baseline Muscle Cross-section Areas at 6 weeks

• Lower extremity muscle strength

  The isometric muscle strength of the quadriceps muscles of the individuals participating in our study will be evaluated using a portable hand dynamometer (Lafayette Manual Muscle Tester, model 01163, USA).

  Change from Baseline Lower Extremity Muscle Strength at 6 weeks

• Hemodynamic responses- blood pressure change

  Systolic blood pressure values and diastolic blood pressure values will be noted separately. A digital blood pressure monitor will be used to assess blood pressure.

  Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure at 6 weeks.

• Hemodynamic responses-saturation

  Saturation (oxygen carrying capacity (SpO2)) will be evaluated with a finger-mounted portable pulse oximeter device.

  Change from Baseline Saturation at 6 weeks

• Hemodynamic responses-heart rate

  A digital heart rate monitor (Polar watch) will be used for heart rate.

  Change from Baseline Heart Rate at 6 weeks

• Hemodynamic responses-respiratory frequency

  Respiratory frequency will be calculated by counting the breaths taken by the patient for 1 minute with a stopwatch.

  Change from Baseline Respiratory Frequency at 6 weeks

Secondary Outcomes (4)

• Hemodynamic responses- blood pressure

  pre-intervention and immediately after the intervention

• Hemodynamic responses- heart rate

  pre-intervention and immediately after the intervention

• Hemodynamic responses-saturation

  pre-intervention and immediately after the intervention

• Hemodynamic responses-respiratory frequency

  pre-intervention and immediately after the intervention

Study Arms (4)

Whole body vibration exercise group

EXPERIMENTAL

The application will be carried out with a whole body vibration device that gives 35 Hz constant vertical vibration. The exercises will be performed on the vibration platform in a standing position and with vibration. 5 static squats (in 90 degrees knee extension), mini squats (120 degrees knee extension), mini squat on the fingertip (120 degrees knee extension), right and left lunge positions, which will be accepted as 180 degrees full knee extension exercise protocol. During the squat exercises, the patient will be positioned with their feet open at shoulder level and the knee flexion angle will be adjusted with a goniometer by the physiotherapist before each training session. For static exercises, the duration will be 3 sets of 30-60 seconds in each practice position. There will be 30-60 second rest breaks between sets.

Other: Whole body vibration exercise

Strength training group

EXPERIMENTAL

The exercises will be performed on the vibration platform but without vibration. Patients will be asked to hold a "body bar" corresponding to 10% of their body weight during exercises. 5 dynamics including squats (in 90 degrees knee extension), mini squats (120 degrees knee extension), mini squats on the toe tip (120 degrees knee extension), right and left lunge exercises, which will be accepted as 180 degrees full knee extension will perform an exercise protocol consisting of exercise. During the squat exercises, the patient will be positioned with their feet open at shoulder level and the knee flexion angle will be adjusted with a goniometer by the physiotherapist before each training session. For dynamic exercise, the duration will be 3 sets of 10 repetitions. Dynamic exercises will be performed with slow and controlled movements, consisting of 3 seconds of eccentric and 2 seconds of concentric phases.

Other: Strengthening exercise

Whole body vibration and strengthening exercise group

EXPERIMENTAL

In the TVVE+KE group, the selected exercises will be performed with vibratory and dynamic strengthening exercises on the vibration platform. The application will be carried out on a whole body vibration device giving a constant vibration of 35 Hz. Patients will be asked to hold a "body bar" corresponding to 10% of their body weight during exercises. 5 dynamics including squats (in 90 degrees knee extension), mini squats (120 degrees knee extension), mini squats on the toe tip (120 degrees knee extension), right and left lunge exercises, which will be accepted as 180 degrees full knee extension will perform an exercise protocol consisting of exercise. D For dynamic exercise, the duration will be 3 sets of 10 repetitions. Dynamic exercises will be performed with slow and controlled movements, consisting of 3 seconds of eccentric and 2 seconds of concentric phases.

Other: Whole body vibration and strengthening exercise

Control Group

NO INTERVENTION

No exercise recommendations or interventions will be made to the patients in the control group.

Interventions

Whole body vibration and strengthening exercise OTHER

Prior to commencing training, all subjects will undergo a pre-screening that includes a thorough history and physical examination to monitor compliance with the inclusion criteria. Evaluation parameters will be evaluated before and after 6 weeks of exercise. Training sessions will be held 3 days a week for 6 weeks, with a minimum of 48 hours between training sessions. All exercise groups include a warm-up period and a cool-down period (stretching exercises). Stretching exercises for the hamstring, gastrocnemius, soleus, and quadriceps muscles will be performed for 15-30 seconds and 3-5 repetitions. The total average application time (including warm-up and cool-down exercises), consisting of exercise and rest periods, was planned as 45-60 minutes for the WBV, SE, and WBV+SE groups.

Whole body vibration and strengthening exercise group

Whole body vibration exercise OTHER

The application will be carried out with a whole body vibration device that gives 35 Hz constant vertical vibration. The exercises will be performed on the vibration platform in a standing position and with vibration. 5 static squats (in 90 degrees knee extension), mini squats (120 degrees knee extension), mini squat on the fingertip (120 degrees knee extension), right and left lunge positions, which will be accepted as 180 degrees full knee extension exercise protocol. During the squat exercises, the patient will be positioned with their feet open at shoulder level and the knee flexion angle will be adjusted with a goniometer by the physiotherapist before each training session. For static exercises, the duration will be 3 sets of 30-60 seconds in each practice position. There will be 30-60 second rest breaks between sets.

Whole body vibration exercise group

Strengthening exercise OTHER

The exercises will be performed on the vibration platform but without vibration. Patients will be asked to hold a "body bar" corresponding to 10% of their body weight during exercises. 5 dynamics including squats (in 90 degrees knee extension), mini squats (120 degrees knee extension), mini squats on the toe tip (120 degrees knee extension), right and left lunge exercises, which will be accepted as 180 degrees full knee extension will perform an exercise protocol consisting of exercise. During the squat exercises, the patient will be positioned with their feet open at shoulder level and the knee flexion angle will be adjusted with a goniometer by the physiotherapist before each training session. For dynamic exercise, the duration will be 3 sets of 10 repetitions. Dynamic exercises will be performed with slow and controlled movements, consisting of 3 seconds of eccentric and 2 seconds of concentric phases.

Strength training group

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 30-59,
• Being diagnosed with stable hypertension in stage 1 (systolic blood pressure 140-159 mmHg and diastolic blood pressure 90-99 mmHg) and stage 2 (systolic blood pressure 160-179 mmHg and diastolic blood pressure 100-109 mmHg),
• Not being obese (BMI\<30 kg/m2)
• Not having the habit of exercise (regular exercise \<60 min/week or not doing any strengthening exercise),
• Not having a history of smoking,
• Volunteering to participate in the study

You may not qualify if:

• Having any additional disease other than hypertension, such as diabetes mellitus, heart failure, unstable angina, myocardial infarction, kidney disease and psychiatric disease related to circulatory, orthopedic, neurological, cardiac and respiratory functions,
• Using hormonal supplements,
• Hypertension-related medication change in the last 4 weeks

Sponsors & Collaborators

• Suleyman Demirel University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Süleyman Demirel Universty

Isparta, Isparta, 32000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Res. Assist.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 20, 2023
• Study Start: February 10, 2023
• Primary Completion: February 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 17, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)