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Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Whole body vibration intervention at 40 Hz
Whole body vibration intervention at 25 Hz
Whole body vibration intervention at 0 Hz
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, whole body vibration

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylül UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Whole body vibration intervention at 40 Hz

Whole body vibration intervention at 25 Hz

Whole body vibration intervention at 0 Hz

Arm Description

40 Hz frequency WBVT

25 Hz frequency WBVT

0 Hz frequency WBVT

Outcomes

Primary Outcome Measures

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.
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.
Blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.

Secondary Outcome Measures

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.
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.
Heart rate
Heart rate will be recorded with Polar heart rate monitor.
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.
Respiratory frequency
It will be counted manually for 30 seconds and multiplied by two.

Full Information

First Posted
February 23, 2023
Last Updated
May 11, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05768555
Brief Title
Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients
Official Title
Investigation of the Effects of Single Session Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, whole body vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration intervention at 40 Hz
Arm Type
Active Comparator
Arm Description
40 Hz frequency WBVT
Arm Title
Whole body vibration intervention at 25 Hz
Arm Type
Active Comparator
Arm Description
25 Hz frequency WBVT
Arm Title
Whole body vibration intervention at 0 Hz
Arm Type
Active Comparator
Arm Description
0 Hz frequency WBVT
Intervention Type
Other
Intervention Name(s)
Whole body vibration intervention at 40 Hz
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Whole body vibration intervention at 25 Hz
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Whole body vibration intervention at 0 Hz
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arterial stiffness
Description
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.
Time Frame
Change from the baseline to the first minutes after the intervention
Title
Heart rate variability
Description
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.
Time Frame
Change from the baseline to the first minutes after the intervention
Title
Blood pressure
Description
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Time Frame
Change from the baseline to the first minutes after the intervention
Secondary Outcome Measure Information:
Title
Muscle strength
Description
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.
Time Frame
Change from the baseline to the first minutes after the intervention
Title
Energy expenditure
Description
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.
Time Frame
During exercise intervention, average 15 minutes
Title
Heart rate
Description
Heart rate will be recorded with Polar heart rate monitor.
Time Frame
Change from the baseline to the first minutes after the intervention
Title
Perceived effort
Description
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.
Time Frame
Change from the baseline to the first minutes after the intervention
Title
Respiratory frequency
Description
It will be counted manually for 30 seconds and multiplied by two.
Time Frame
Change from the baseline to the first minutes after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bilge KOKSAL
Phone
+905078608470
Email
blg.koksal@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sema Savcı
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
State/Province
Balçova
ZIP/Postal Code
35140
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Whole Body Vibration Training Applied With Different Frequencies in Hypertensive Patients

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