NCT05768555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

November 20, 2024

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 23, 2023

Last Update Submit

November 17, 2024

Conditions

Keywords

hypertensionwhole body vibration

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Muscle strength

    Change from the baseline to the first minutes after the intervention

  • Energy expenditure

    During exercise intervention, average 15 minutes

  • Heart rate

    Change from the baseline to the first minutes after the intervention

  • Perceived effort

    Change from the baseline to the first minutes after the intervention

  • Respiratory frequency

    Change from the baseline to the first minutes after the intervention

Study Arms (3)

Whole body vibration intervention at 40 Hz

ACTIVE COMPARATOR

40 Hz frequency WBVT

Other: Whole body vibration intervention at 40 Hz

Whole body vibration intervention at 25 Hz

ACTIVE COMPARATOR

25 Hz frequency WBVT

Other: Whole body vibration intervention at 25 Hz

Whole body vibration intervention at 0 Hz

ACTIVE COMPARATOR

0 Hz frequency WBVT

Other: Whole body vibration intervention at 0 Hz

Interventions

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 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 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 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 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.

Whole body vibration intervention at 0 Hz

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sema Savcı

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 14, 2023

Study Start

October 14, 2022

Primary Completion

June 13, 2023

Study Completion

June 21, 2023

Last Updated

November 20, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations