ObesityRTNCT03865368
Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity
A study testing Whole Body Vibration Training in people with Obesity and Blood Pressure, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Blood Pressure, Whole Body Vibration
- What is being tested?
- Whole Body Vibration Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 27 Feb 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between age 18-65 with Body Mass Index (BMI) of >29.9 kg/m2
Who cannot join
- Unstable hypertensive patients
- History of cardiovascular, neurologic, or orthopedic diseases,
- Presence of knee prosthesis, hip replacement
- Chronic inflammatory disease,
- Anti-inflammatory treatment
- Cognitive impairments
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University Sports Laboratory
Istanbul, 34959
About this study
Official title: Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive Patients With Obesity
Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.
- Conditions
- Obesity, Blood Pressure, Whole Body Vibration, Exercise
- Being tested
- Whole Body Vibration Training
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration TrainingOther
Also called Standard Exercise
Whole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body
| Study group | Role | What they receive |
|---|---|---|
| Active Whole Body Vibration Training | Experimental | Exercises were taught during the first session, active training was done in the second session, and acute evaluations were made during the third session. Both groups performed the dynamic exercises, under supervision, on the whole body vibration device with 10-second rest intervals. Throughout the WBVT session, the vibration amplitude was set to 2 mm and exercise frequency 30 Hz. Receives: Other: Whole Body Vibration Training |
| Control Group | Active comparator | The same exercises as the aWBVT group were performed on the vibration platform, with the vibration application turned off Receives: Other: Whole Body Vibration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate was evaluated from the brachial artery using a sphygmanometer.
Measured: "20 minute"
Blood pressure
Blood pressure was evaluated using a sphygmomanometer.
Measured: "20 minute"
Secondary outcomes (1)
Fatigue
Borg's Rating of Perceived Exertion Scale. Minimum score: 6 Maximum score: 20 The Borg Rating of Perceived Exertion scale helps estimate activity intensity.
Measured: "20 minute"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Nov 2018
- Primary completion15 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Tülay Çevik, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865368
- Sponsor's protocol ID
- Okan_University
- Acronym
- RT
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive Patients With Obesity
- ClinicalTrials.gov ID
- NCT03865368
- Acronym / sponsor ID
- RT / Okan_University
- Conditions
- Obesity, Blood Pressure, Whole Body Vibration, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 6 Mar 2019 (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.
Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period
| Arm | Type | Receives |
|---|---|---|
| Active Whole Body Vibration Training | Experimental | Other: Whole Body Vibration TrainingExercises were taught during the first session, active training was done in the second session, and acute evaluations were made during the third session. Both groups performed the dynamic exercises, under supervision, on the whole body vibration device with 10-second rest intervals. Throughout the WBVT session, the vibration amplitude was set to 2 mm and exercise frequency 30 Hz. |
| Control Group | Active comparator | Other: Whole Body Vibration TrainingThe same exercises as the aWBVT group were performed on the vibration platform, with the vibration application turned off |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals between age 18-65 with Body Mass Index (BMI) of >29.9 kg/m2
Key exclusion criteria (7 listed)
- Unstable hypertensive patients
- History of cardiovascular, neurologic, or orthopedic diseases,
- Presence of knee prosthesis, hip replacement
- Chronic inflammatory disease,
- Anti-inflammatory treatment
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 TrainingAlso: Standard ExerciseWhole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body | Other | Active Whole Body Vibration Training, Control Group |
Primary outcome
Heart rate
Time frame: "20 minute"
Heart rate was evaluated from the brachial artery using a sphygmanometer.
Blood pressure
Time frame: "20 minute"
Blood pressure was evaluated using a sphygmomanometer.
1 secondary outcome
Fatigue
Time frame: "20 minute"
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 6 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Training in people with Obesity and Blood Pressure, run by Okan 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 1 inclusion and 7 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 6 Mar 2019. 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?
Heart rate (time frame: "20 minute"). The study lists 2 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 6 Mar 2019.