Whole Body Vibration Training Applied with Different Frequencies in Hypertensive Patients

November 17, 2024 updated by: Bilge Köksal, Dokuz Eylul University

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Balçova
      • İzmir, Balçova, Turkey, 35140
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole body vibration intervention at 40 Hz
40 Hz frequency WBVT
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.
Active Comparator: Whole body vibration intervention at 25 Hz
25 Hz frequency WBVT
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.
Active Comparator: Whole body vibration intervention at 0 Hz
0 Hz frequency WBVT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial stiffness
Time Frame: Change from the baseline to the first minutes after the intervention
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
Heart rate variability
Time Frame: Change from the baseline to the first minutes after the intervention
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
Blood pressure
Time Frame: Change from the baseline to the first minutes after the intervention
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Change from the baseline to the first minutes after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Change from the baseline to the first minutes after the intervention
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
Energy expenditure
Time Frame: During exercise intervention, average 15 minutes
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
Heart rate
Time Frame: Change from the baseline to the first minutes after the intervention
Heart rate will be recorded with Polar heart rate monitor.
Change from the baseline to the first minutes after the intervention
Perceived effort
Time Frame: Change from the baseline to the first minutes after the intervention
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
Respiratory frequency
Time Frame: Change from the baseline to the first minutes after the intervention
It will be counted manually for 30 seconds and multiplied by two.
Change from the baseline to the first minutes after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Sema Savcı, Dokuz Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Actual)

June 13, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DokuzEU-HT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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