HypertensionNCT05768555
Whole Body Vibration Training Applied with Different Frequencies in Hypertensive Patients
A study testing Whole body vibration intervention at 40 Hz, Whole body vibration intervention at 25 Hz and Whole body vibration intervention at 0 Hz in people with Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Whole body vibration intervention at 40 Hz, Whole body vibration intervention at 25 Hz and Whole body vibration intervention at 0 Hz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2022to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Whole body vibration intervention at 40 Hz, Whole body vibration intervention at 25 Hz, Whole body vibration intervention at 0 Hz
- Keywords
- hypertension, whole body vibration
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration intervention at 40 HzOther
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 HzOther
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 HzOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration intervention at 40 Hz | Active comparator | 40 Hz frequency WBVT Receives: Other: Whole body vibration intervention at 40 Hz |
| Whole body vibration intervention at 25 Hz | Active comparator | 25 Hz frequency WBVT Receives: Other: Whole body vibration intervention at 25 Hz |
| Whole body vibration intervention at 0 Hz | Active comparator | 0 Hz frequency WBVT Receives: Other: Whole body vibration intervention at 0 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from the baseline to the first minutes after the intervention
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.
Measured: Change from the baseline to the first minutes after the intervention
Blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Measured: Change from the baseline to the first minutes after the intervention
Secondary outcomes (5)
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.
Measured: Change from the baseline to the first minutes after the intervention
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.
Measured: During exercise intervention, average 15 minutes
Heart rate
Heart rate will be recorded with Polar heart rate monitor.
Measured: Change from the baseline to the first minutes after the intervention
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.
Measured: Change from the baseline to the first minutes after the intervention
Respiratory frequency
It will be counted manually for 30 seconds and multiplied by two.
Measured: Change from the baseline to the first minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start14 Oct 2022
- Primary completion13 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Köksal, Dokuz Eylul University
- Investigators
- Sema Savcı, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768555
- Sponsor's protocol ID
- DokuzEU-HT-001
- Status last verified
- May 2023
- First submitted
- 23 Feb 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Single Session Whole Body Vibration Training Applied with Different Frequencies in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05768555
- Acronym / sponsor ID
- DokuzEU-HT-001
- Conditions
- Hypertension
- Keywords
- hypertension, whole body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration intervention at 40 Hz | Active comparator | Other: Whole body vibration intervention at 40 Hz40 Hz frequency WBVT |
| Whole body vibration intervention at 25 Hz | Active comparator | Other: Whole body vibration intervention at 25 Hz25 Hz frequency WBVT |
| Whole body vibration intervention at 0 Hz | Active comparator | Other: Whole body vibration intervention at 0 Hz0 Hz frequency WBVT |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being diagnosed with hypertension
- Being clinically stable
- Becoming a volunteer
- Walking independently
- Not taking medication or hormone therapy in the year before the study
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration intervention at 40 HzWhole 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. | Other | Whole body vibration intervention at 40 Hz |
| Whole body vibration intervention at 25 HzWhole 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. | Other | Whole body vibration intervention at 25 Hz |
| Whole body vibration intervention at 0 HzWhole 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. | Other | Whole body vibration intervention at 0 Hz |
Primary outcome
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.
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.
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.
5 secondary outcomes
Muscle strength
Time frame: Change from the baseline to the first minutes after the intervention
Energy expenditure
Time frame: During exercise intervention, average 15 minutes
Heart rate
Time frame: 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
Respiratory frequency
Time frame: Change from the baseline to the first minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sema Savcı study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration intervention at 40 Hz, Whole body vibration intervention at 25 Hz and Whole body vibration intervention at 0 Hz in people with Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: Change from the baseline to the first minutes after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.