HealthyPhase 1/2EWBVEPQLNCT01538888
Effects Whole Body Vibration in Ergospirometrics Parameters and Quality of Life
A Phase 1/2 study testing WHOLE BODY VIBRATION in people with Healthy, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. A case that is run like a vibration training combined, increasing strength and VO2. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- WHOLE BODY VIBRATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 1/2
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 to 74 years
- sedentary or irregularly active according to the IPAQ short form with no known diseases
Who cannot join
- smoking
- acute hernia
- thrombosis
- labyrinthitis
- diabetes
- hemodynamic instability
Show all 13Show fewer
- obesity
- osteoporosis
- neuromuscular diseases
- pulmonary comorbidities
- heart disease
- electrocardiographic changes during exercise
- taking medications that affected bone metabolism or muscle and don't adapt to any of the protocols
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Whole Body Vibration in Ergospirometrics Parameters, Strength And Quality of Life: A Randomised Controlled Trial
This study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. A case that is run like a vibration training combined, increasing strength and VO2.
Read the detailed description
The search use the spirometric values after whole body vibration training and resistance training
- Conditions
- Healthy
- Being tested
- WHOLE BODY VIBRATION
- Keywords
- WHOLE BODY VIBRATION, AGED, VO2, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOLE BODY VIBRATIONProcedure or surgery
Also called POWER PLATE, MODEL MY3
03 MONTHS, TWICE PER WEEK
| Study group | Role | What they receive |
|---|---|---|
| WHOLE BODY VIBRATION | Experimental | SEARCH THE CARDIOPULMONARY EFFECTS IN WHOLE BODY VIBRATION IN HEALTH ELDERLY Receives: Procedure: WHOLE BODY VIBRATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2
change to maximal oxygen consumption (ml.kg.min)in ergospirometric test after 03 months training in vibrating platform twice per weeck.
Measured: 03 MONTHS IN INTERVENTION
Secondary outcomes (1)
quality of life
outcome measure with the SF 36 shot form (Medical Outcomes Study 36 - Item short form health survey)after 03 months training in vibrating platform twice per weeck
Measured: 03 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maíra F Pessoa, Universidade Federal de Pernambuco
- Investigators
- Maíra F Pessoa, MS, Study director, Universidade Federal de PernambucoRafaela B Sá, MS, Study chair, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538888
- Sponsor's protocol ID
- EQ1
- Acronym
- EWBVEPQL
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Whole Body Vibration in Ergospirometrics Parameters, Strength And Quality of Life: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01538888
- Acronym / sponsor ID
- EWBVEPQL / EQ1
- Conditions
- Healthy
- Keywords
- WHOLE BODY VIBRATION, AGED, VO2, muscle strength
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- 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.
This study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. A case that is run like a vibration training combined, increasing strength and VO2.
Detailed description
The search use the spirometric values after whole body vibration training and resistance training
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WHOLE BODY VIBRATION | Experimental | Procedure: WHOLE BODY VIBRATIONSEARCH THE CARDIOPULMONARY EFFECTS IN WHOLE BODY VIBRATION IN HEALTH ELDERLY |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 60 to 74 years
- sedentary or irregularly active according to the IPAQ short form with no known diseases
Key exclusion criteria (13 listed)
- smoking
- acute hernia
- thrombosis
- labyrinthitis
- diabetes
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 VIBRATIONAlso: POWER PLATE, MODEL MY303 MONTHS, TWICE PER WEEK | Procedure or surgery | WHOLE BODY VIBRATION |
Primary outcome
VO2
Time frame: 03 MONTHS IN INTERVENTION
change to maximal oxygen consumption (ml.kg.min)in ergospirometric test after 03 months training in vibrating platform twice per weeck.
1 secondary outcome
quality of life
Time frame: 03 month
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 24 Feb 2012.
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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.
Maíra F Pessoa, MS study director
Universidade Federal de Pernambuco
Rafaela B Sá, MS study chair
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WHOLE BODY VIBRATION in people with Healthy, 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 2 inclusion and 13 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 24 Feb 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VO2 (time frame: 03 MONTHS IN INTERVENTION). 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 24 Feb 2012.