AgingEVAWIENCT01681719
Ergospirometric Values and WBV in Elderly
A study testing WBV and Resistance in people with Aging, run by Maíra F Pessoa at 1 site in Brazil.
Trial summary
this study aims evaluate the ergospirometric values after 03 months of training with WBV in elderly health people. The hypothesis is increases of ergospirometric values. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- WBV and Resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2011
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60-74 years,
- Sedentary or Moderate A in accord with IPAQ short form (International Physical Activity Questionnaire) and those without disease.
- furthermore, the subjects should reach the ventilatory threshold 1, considered after meeting two of the following events:
- respiratory quotient (R) increases (R ≥1,1);
- loss of linearity between the pulmonary ventilation curve (VE) and oxygen consumption (VO2), plateau of VO2 or plateau of heart rate (HR) and increases of end-tidal PO2 (Pet O2)
Who cannot join
- Were excluded subjects with changes in Mini-mental state examination (MMSE) scores by age and educational level where the minimum score represents: illiterate 13 points, less than 8 study years is 18 points, 8 or more study years is 26 points 11.
- Were also excluded current smokers or previous, subjects with thrombosis, labyrinthitis, diabetes, hemodynamic instabilities, obesity, osteoporosis, neuromuscular diseases, pulmonary or cardiac diseases, changes in resting electrocardiogram or in exercise, ingestion of drugs to metabolism bone / muscle / heart chronotropism or with difficulties in adapting protocols
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Body Vibration as Alternative for Improve the Ergospirometric Values in Elderly: a Randomized Clinical Trial
this study aims evaluate the ergospirometric values after 03 months of training with WBV in elderly health people. The hypothesis is increases of ergospirometric values.
- Conditions
- Aging
- Being tested
- WBV and Resistance, resistance & sham WBV, WBV & resistance sham
- Keywords
- VO2, VCO2, VE/VO2, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV and ResistanceDevice
use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight.
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.
resistance & sham WBVDevice
used only resistance
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK)off.
WBV & resistance shamDevice
used really the WBV, but sham for resistance training
For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.
| Study group | Role | What they receive |
|---|---|---|
| WBV and resistance | Experimental | used both interventions Receives: Device: WBV and Resistance |
| WBV & resistance sham | Experimental | used the vibrating platform and sham for resistance training Receives: Device: WBV & resistance sham |
| Resistance & sham WBV | Experimental | used resistance exercises and sham for vibrating platform Receives: Device: resistance & sham WBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal O2 consumption
Measured: started and finished the protocol after 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maíra F Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maíra F Pessoa, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681719
- Sponsor's protocol ID
- ERGOFORCE1
- Acronym
- EVAWIE
- Status last verified
- Sep 2012
- First submitted
- 30 Aug 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration as Alternative for Improve the Ergospirometric Values in Elderly: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01681719
- Acronym / sponsor ID
- EVAWIE / ERGOFORCE1
- Conditions
- Aging
- Keywords
- VO2, VCO2, VE/VO2, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maíra F PessoaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 10 Sep 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 aims evaluate the ergospirometric values after 03 months of training with WBV in elderly health people. The hypothesis is increases of ergospirometric values.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WBV and resistance | Experimental | Device: WBV and Resistanceused both interventions |
| WBV & resistance sham | Experimental | Device: WBV & resistance shamused the vibrating platform and sham for resistance training |
| Resistance & sham WBV | Experimental | Device: resistance & sham WBVused resistance exercises and sham for vibrating platform |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 60-74 years,
- Sedentary or Moderate A in accord with IPAQ short form (International Physical Activity Questionnaire) and those without disease.
- furthermore, the subjects should reach the ventilatory threshold 1, considered after meeting two of the following events:
- respiratory quotient (R) increases (R ≥1,1);
- loss of linearity between the pulmonary ventilation curve (VE) and oxygen consumption (VO2), plateau of VO2 or plateau of heart rate (HR) and increases of end-tidal PO2 (Pet O2)
Key exclusion criteria (2 listed)
- Were excluded subjects with changes in Mini-mental state examination (MMSE) scores by age and educational level where the minimum score represents: illiterate 13 points, less than 8 study years is 18 points, 8 or more study years is 26 points 11.
- Were also excluded current smokers or previous, subjects with thrombosis, labyrinthitis, diabetes, hemodynamic instabilities, obesity, osteoporosis, neuromuscular diseases, pulmonary or cardiac diseases, changes in resting electrocardiogram or in exercise, ingestion of drugs to metabolism bone / muscle / heart chronotropism or with difficulties in adapting protocols
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 |
|---|---|---|
| WBV and Resistanceuse of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight. For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction. For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min. | Device | WBV and resistance |
| resistance & sham WBVused only resistance For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction. For WBV: used MY3 platform (Power Plate®, MY3, UK)off. | Device | Resistance & sham WBV |
| WBV & resistance shamused really the WBV, but sham for resistance training For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights. For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min. | Device | WBV & resistance sham |
Primary outcome
maximal O2 consumption
Time frame: started and finished the protocol after 03 months
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 10 Sep 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.
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 WBV and Resistance in people with Aging, run by Maíra F Pessoa 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 2 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 10 Sep 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.
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?
maximal O2 consumption (time frame: started and finished the protocol after 03 months). 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 10 Sep 2012.