Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Investigation of the Effects of Single Session Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768555
• Other study ID #: DokuzEU-HT-001
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: June 2023

Study information

• Verified date: May 2023
• Source: Dokuz Eylul University
• Contact: Bilge KOKSAL
• Phone: +905078608470
• Email: blg.koksal[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At least 36 volunteers with a diagnosis of hypertension in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. The aim of this study is to compare the acute effects on atherosclerosis, heart rate variability, blood pressure, perceived exertion, energy expenditure, and muscle strength of using different frequencies in whole body vibration training (WBVT) in hypertensive patients. Individuals will perform; static squat, dynamic toe raise, static abduction and dynamic squat exercises in both hips on a vibrating platform. In each session, a different frequency (0,25 and 40 Hz) will be applied. 0 Hz, 25 Hz and 40 Hz sessions will be randomized to last 15 minutes. Demographic and clinical information of the participants will be questioned.Before and after the sessions; hemodynamic and pulmonary responses, vascular responses, heart rate variability and quadriceps femoris muscle strength will be measured. In addition, energy expenditure will be recorded during the sessions.

Description:

Hypertension is one of the most common chronic diseases and it is an important global public health problem. In cardiac rehabilitation programs, aerobic exercise, resistance exercise and a combination of aerobic and resistance exercise are recommended to reduce cardiovascular risk. Whole body vibration training has also started to be used among new applications in the cardiac rehabilitation programs. Whole body vibration training has been reported as an effective and safe approach for both healthy and cardiovascular diseased women and men. It has been shown to be beneficial in improving atherosclerosis and blood pressure in hypertensive patients. In whole body vibration training, frequencies of 20-40 Hz are generally used for hypertensive elderly patients. However, the optimal frequency in this population has not been fully determined. For these reasons, the aim of the study is to compare the acute effects of using different frequencies in whole body vibration training in hypertensive patients.

Whole body vibration intervention will be performed with the Power Plate Pro 5 device (Power Plate International, London, UK). Whole body vibration training will be performed at three different frequencies (0, 25 and 40 Hz). Each patient will complete the training in these 3 frequencies in random order and on different days. Before and after the sessions; hemodynamic and pulmonary responses, vascular responses, heart rate variability and quadriceps femoris muscle strength will be measured. In addition, energy expenditure will be recorded during the sessions.Individuals will perform; static squat, dynamic toe raise, static abduction and dynamic squat exercises in both hips on a vibrating platform. All exercises will consist of 45 seconds of vibration and 15 seconds of rest. Each exercise will be repeated three times. Total intervention time will be 15 minutes. Participants will perform whole body vibration trainings at different frequencies in a randomized order with at least one day apart.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with hypertension

• Being clinically stable

• Becoming a volunteer

• Walking independently

• Not taking medication or hormone therapy in the year before the study

• Lack of regular exercise habit (<60 minutes/week of exercise)

Exclusion Criteria:

• Having a serious cardiovascular/pulmonary condition

• Having an operation in the last 6 months

• Presence of acute thrombosis

• Presence of arrhythmia

• Presence of unstable angina

• Recent decompensated heart failure

• Recent myocardial infarction

• Using an assistive device to walk

• Neurological disorders (such as stroke, Parkinson's)

• Being diagnosed with vertigo

• Being diagnosed with epilepsy

• Kidney failure and history of kidney stones

• Hip or knee implants

• Recent fractures or injuries (<6 months).

• Using a prosthesis

• Pregnancy

• Participation in any training program in the 3 months before study

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Whole body vibration intervention at 40 Hz
Whole body vibration intervention will be performed with the Power Plate Pro 5 device (Power Plate International, London, UK). Whole body vibration training will be performed at a frequency of 40 Hz. Individuals will perform; static squat, dynamic toe raise, static abduction and dynamic squat exercises in both hips on a vibrating platform. All exercises will consist of 45 seconds of vibration and 15 seconds of rest. Each exercise will be repeated three times. Total intervention time will be 15 minutes.
• Whole body vibration intervention at 25 Hz
Whole body vibration intervention will be performed with the Power Plate Pro 5 device (Power Plate International, London, UK). Whole body vibration training will be performed at a frequency of 25 Hz. Individuals will perform; static squat, dynamic toe raise, static abduction and dynamic squat exercises in both hips on a vibrating platform. All exercises will consist of 45 seconds of vibration and 15 seconds of rest. Each exercise will be repeated three times. Total intervention time will be 15 minutes.
• Whole body vibration intervention at 0 Hz
Whole body vibration intervention will be performed with the Power Plate Pro 5 device (Power Plate International, London, UK). Whole body vibration training will be performed at a frequency of 0 Hz. Individuals will perform; static squat, dynamic toe raise, static abduction and dynamic squat exercises in both hips on a vibrating platform. All exercises will consist of 45 seconds of vibration and 15 seconds of rest. Each exercise will be repeated three times. Total intervention time will be 15 minutes.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir	Balçova

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. The patient's age(years), gender(male), blood pressure(mmHg), height(cm), weight(kg), carotid-sternal notch distance between the artery, carotid-femoral artery as the distance between the entered data to the computer after increasing pressure over the brachial artery through a transducer (augmentation index) and again, carotid-femoral pulse wave velocity via the artery (pulse wave velocity) measurements will be made.	Change from the baseline to the first minutes after the intervention
Primary	Heart rate variability	Heart rate variability will be assessed by heart rate variability (HRV), a non-invasive measurement. Sympathetic and parasympathetic autonomic function will be evaluated with HRV software. HRV provides time and frequency domain parameters associated with autonomic function.	Change from the baseline to the first minutes after the intervention
Primary	Blood pressure	Systolic and diastolic blood pressure will be measured with a sphygmomanometer.	Change from the baseline to the first minutes after the intervention
Secondary	Muscle strength	Lower extremity quadriceps muscle strength will be evaluated with a digital dynamometer (Lafayette, USA). The knee and hip joint will be measured in a 90-degree sitting position. The dynamometer will be stabilized by a plastic sheath and an inelastic belt. Measurements will be performed on both lower extremities and for each extremity, the best value will be recorded from the measurements repeated 3 times. Higher values indicate better quadriceps muscle strength.	Change from the baseline to the first minutes after the intervention
Secondary	Energy expenditure	Energy expenditure during whole body vibration trainings with different frequencies will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm.	During exercise intervention, average 15 minutes
Secondary	Heart rate	Heart rate will be recorded with Polar heart rate monitor.	Change from the baseline to the first minutes after the intervention
Secondary	Perceived effort	The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg 0-10). As the modified borg score of the person increases, the perceived effort will increase.	Change from the baseline to the first minutes after the intervention
Secondary	Respiratory frequency	It will be counted manually for 30 seconds and multiplied by two.	Change from the baseline to the first minutes after the intervention