HealthyNCT03180814
Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly
A study testing Whole Body Vibration in people with Healthy and Aging, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Whole Body Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2017to 30 Dec 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly individuals aged between 60 and 80 years
- Young individuals aged between 18 and 30 years
- Able to walk without assistance
- Good understanding to perform the proposed procedures
- Sedentary or low active
Who cannot join
- Body Mass Index (BMI) > 35Kg/m2
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg (at rest)
- Difficulty adapting to the whole body vibration
- Smoking
- Neuromuscular or degenerative disorders
- Neurological diseases
Show all 12Show fewer
- Cardiopulmonary comorbidities
- Cardiac arrhythmias
- Osteoarticular disorders
- Use of hormone replacement therapy
- Use medications or supplements known to affect cardiovascular parameters
- Labyrinthitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly
Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. The investigators' hypothesis is that whole body vibration has different effects in young and elderly.
- Being tested
- Whole Body Vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationOther
A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.
| Study group | Role | What they receive |
|---|---|---|
| Young Group | Active comparator | Healthy young of both sexes between the ages of 18 and 30 years will perform a whole body vibration session Receives: Other: Whole Body Vibration |
| Elderly Group | Experimental | Healthy elderly of both sexes between the ages of 60 and 80 years will perform a whole body vibration session Receives: Other: Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Function
Heart rate variability will be assessed from 3-channel holter
Measured: Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes
Secondary outcomes (7)
Sympathetic modulation
Sympathetic modulation will be assessed from 3-channel holter
Measured: Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes
Parasympathetic modulation
Parasympathetic modulation will be assessed from 3-channel holter
Measured: Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes
Sympathovagal Balance
Sympathovagal Balance will be assessed from 3-channel holter
Measured: Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes
Heart Rate
Non-invasive measures will be assessed from 3-channel holter
Measured: Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes
Blood pressure
Non-invasive measures of brachial blood pressure
Measured: Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes
Peripheral oxygen saturation
Non-invasive measures will be assessed from pulse oximeter
Measured: Change from Baseline Peripheral oxygen saturation at 5, 10, 15, 20 and 35 minutes
Adverse effects
Adverse effects reported by volunteers
Measured: Change from Baseline at 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start31 Jul 2017
- Primary completion31 Aug 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180814
- Sponsor's protocol ID
- WBV on autonomic function
- Status last verified
- Dec 2017
- First submitted
- 21 Mar 2017
- Last updated
- 3 Jan 2018
- 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 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly
- ClinicalTrials.gov ID
- NCT03180814
- Acronym / sponsor ID
- WBV on autonomic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 8 Jun 2017 (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.
Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. The investigators' hypothesis is that whole body vibration has different effects in young and elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Group | Active comparator | Other: Whole Body VibrationHealthy young of both sexes between the ages of 18 and 30 years will perform a whole body vibration session |
| Elderly Group | Experimental | Other: Whole Body VibrationHealthy elderly of both sexes between the ages of 60 and 80 years will perform a whole body vibration session |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly individuals aged between 60 and 80 years
- Young individuals aged between 18 and 30 years
- Able to walk without assistance
- Good understanding to perform the proposed procedures
- Sedentary or low active
Key exclusion criteria (12 listed)
- Body Mass Index (BMI) > 35Kg/m2
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg (at rest)
- Difficulty adapting to the whole body vibration
- Smoking
- Neuromuscular or degenerative disorders
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 VibrationA whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm. | Other | Elderly Group, Young Group |
Primary outcome
Autonomic Function
Time frame: Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes
Heart rate variability will be assessed from 3-channel holter
7 secondary outcomes
Sympathetic modulation
Time frame: Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes
Parasympathetic modulation
Time frame: Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes
Sympathovagal Balance
Time frame: Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes
Heart Rate
Time frame: Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes
Blood pressure
Time frame: Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes
Peripheral oxygen saturation
Time frame: Change from Baseline Peripheral oxygen saturation at 5, 10, 15, 20 and 35 minutes
Adverse effects
Time frame: Change from Baseline at 20 minutes
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 3 Jan 2018.
- 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.
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 in people with Healthy and Aging, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 5 inclusion and 12 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 3 Jan 2018. 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 Brazil. 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?
Autonomic Function (time frame: Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes). 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 3 Jan 2018.