- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768555
Whole Body Vibration Training Applied with Different Frequencies in Hypertensive Patients
Investigation of the Effects of Single Session Whole Body Vibration Training Applied with Different Frequencies in Hypertensive Patients
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Balçova
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İzmir, Balçova, Turkey, 35140
- Dokuz Eylül University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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During exercise intervention, average 15 minutes
|
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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
Sponsor
Investigators
- Study Director: Sema Savcı, Dokuz Eylül University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU-HT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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