Neuromuscular Performance and BalanceNCT03356418
Immediate Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly
A study testing WBV exercise group in people with Neuromuscular Performance and Balance, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the immediate effects of an exercise protocol on the vibration platform on the functional and neuromuscular performance of lower limbs, postural control and life quality in healthy elderly. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Performance and Balance
- What is being tested?
- WBV exercise group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2018to 10 May 2018
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Both genders;
- Exhibiting ankle, hip and knee joint integrity of the non-dominant limb;
- No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments;
- Do not have metallic implants in the lower limbs;
- Do not have decompensated and / or untreated cardiovascular diseases;
- Do not have advanced osteoporosis;
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- Do not have neurodegenerative diseases;
- Do not have vestibular disorders;
- Do not have uncorrected visual or hearing deficits.
Who cannot join
- Elderly classified as very active or active;
- Report cardiac and / or respiratory discomfort, nausea, vertigo and pain during during the evaluations and exercise sessions;
- Do not understand and do not correctly perform the commands offered in the assessment and / or intervention protocols;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59140-840
About this study
Official title: Immediate Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial
The purpose of this study is to analyze the immediate effects of an exercise protocol on the vibration platform on the functional and neuromuscular performance of lower limbs, postural control and life quality in healthy elderly.
Read the detailed description
The research is a randomized controlled trial that will be developed at the Laboratório de Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal University of Rio Grande do Norte (UFRN). The population of the present study will be formed by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of both sexes, without distinction of race, education and marital status. The research sample will be of a non-probabilistic type, in which these will be allocated randomly into two distinct groups: placebo group (GP) and experimental group (GE). This research was submitted to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of the National Health Council (CNS) and the Declaration of Helsinki for research with humans. In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a database of the laboratory under confidentiality and can only be handled by the responsible researchers. The study will only begin after the issuance of the referent opinion approving the project. All subjects will be duly informed and instructed regarding the scheduled procedures, which will only be executed after reading, accepting and signing the Term of Free and Informed Consent (TFIC). After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research procedures, as well as the training of the researchers involved. Initially the research will begin with the selection of the sample according to the inclusion criteria descried elsewhere. The evaluation will be scheduled by telephone contact. Following this, the volunteers will receive the TFIC for reading and due signature. The data collection process will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application of exercise program and (4)reevaluation. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography) and postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo group (with the platform off) or experimental group (with the platform set at a frequency of 40 Hz and amplitude of 4 mm). Both will perform a bout of exercise in the vibrating platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5 min, with a rest interval of 1 minute. Immediately after the exercise the volunteers will be submitted to a revaluation, with the same procedures of the initial evaluation.
- Conditions
- Neuromuscular Performance and Balance
- Being tested
- WBV exercise group, Sham WBV exercise group
- Keywords
- Exercise, Vibration, Torque, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV exercise groupOther
The intervention will consist of a half-squat isometric whole-body vibration exercise with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
Sham WBV exercise groupOther
The intervention will consist of as half-squat isometric exercise , but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.
| Study group | Role | What they receive |
|---|---|---|
| WBV exercise group | Experimental | Subjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will be connected at the beginning of each series, set at a vibration frequency of 40 Hertz (Hz) and peak-to-peak amplitude of 4 millimeters (mm) resulting in a peak acceleration of 128 ms2 (12.8 g). This should provide the equivalent of 3600 vertical vibrations, totaling 14400 vibrations per training session Receives: Other: WBV exercise group |
| Sham WBV exercise group | Sham comparator | Subjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation. Receives: Other: Sham WBV exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average power measured through isokinetic dynamometer
Measured through isokinetic dynamometry. The analyzed variable will be average power (in watts).
Measured: Baseline and immediately after the intervention protocol.
Secondary outcomes (5)
Change in Muscle activation measured through surface electromyography
Measured by surface electromyography. The analyzed variable will be the amplitude of muscle activation (in microvolts).
Measured: Baseline and immediately after the intervention protocol.
Change in Balance measured through baropodometry
Measured by baropodometry. The analyzed variable will be the oscilation of center of pressure (in mm).
Measured: Baseline and immediately after the intervention protocol .
Change in peak torque normalized by body weight measured through isokinetic dynamometer
Measured through isokinetic dynamometry. The analyzed variable will be a combination of peak torque normalized by body weight (in percentage).
Measured: Baseline and immediately after the intervention protocol.
Change in total work measured through isokinetic dynamometer
Measured through isokinetic dynamometry. The analyzed variable will be total work (in joules).
Measured: Baseline and immediately after the intervention protocol.
Change in peak torque measured through isokinetic dynamometer
Measured through isokinetic dynamometry. The analyzed variable will be peak torque (in Newtons).
Measured: Baseline and immediately after the intervention protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start10 Mar 2018
- Primary completion10 Apr 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Performance and BalanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
- Investigators
- Daniel T Borges, MS, Principal investigator, Universidade Federal do Rio Grande do NorteLidiane C Bulhões, Esp, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356418
- Sponsor's protocol ID
- DL2017.2
- Status last verified
- Jun 2019
- First submitted
- 19 Nov 2017
- Last updated
- 18 Jun 2019
- 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 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03356418
- Acronym / sponsor ID
- DL2017.2
- Conditions
- Neuromuscular Performance and Balance
- Keywords
- Exercise, Vibration, Torque, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 29 Nov 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.
The purpose of this study is to analyze the immediate effects of an exercise protocol on the vibration platform on the functional and neuromuscular performance of lower limbs, postural control and life quality in healthy elderly.
Detailed description
The research is a randomized controlled trial that will be developed at the Laboratório de Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal University of Rio Grande do Norte (UFRN). The population of the present study will be formed by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of both sexes, without distinction of race, education and marital status. The research sample will be of a non-probabilistic type, in which these will be allocated randomly into two distinct groups: placebo group (GP) and experimental group (GE). This research was submitted to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of the National Health Council (CNS) and the Declaration of Helsinki for research with humans. In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a database of the laboratory under confidentiality and can only be handled by the responsible researchers. The study will only begin after the issuance of the referent opinion approving the project. All subjects will be duly informed and instructed regarding the scheduled procedures, which will only be executed after reading, accepting and signing the Term of Free and Informed Consent (TFIC). After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research procedures, as well as the training of the researchers involved. Initially the research will begin with the selection of the sample according to the inclusion criteria descried elsewhere. The evaluation will be scheduled by telephone contact. Following this, the volunteers will receive the TFIC for reading and due signature. The data collection process will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application of exercise program and (4)reevaluation. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography) and postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo group (with the platform off) or experimental group (with the platform set at a frequency of 40 Hz and amplitude of 4 mm). Both will perform a bout of exercise in the vibrating platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5 min, with a rest interval of 1 minute. Immediately after the exercise the volunteers will be submitted to a revaluation, with the same procedures of the initial evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBV exercise group | Experimental | Other: WBV exercise groupSubjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will be connected at the beginning of each series, set at a vibration frequency of 40 Hertz (Hz) and peak-to-peak amplitude of 4 millimeters (mm) resulting in a peak acceleration of 128 ms2 (12.8 g). This should provide the equivalent of 3600 vertical vibrations, totaling 14400 vibrations per training session |
| Sham WBV exercise group | Sham comparator | Other: Sham WBV exercise groupSubjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Both genders;
- Exhibiting ankle, hip and knee joint integrity of the non-dominant limb;
- No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments;
- Do not have metallic implants in the lower limbs;
- Do not have decompensated and / or untreated cardiovascular diseases;
Key exclusion criteria (3 listed)
- Elderly classified as very active or active;
- Report cardiac and / or respiratory discomfort, nausea, vertigo and pain during during the evaluations and exercise sessions;
- Do not understand and do not correctly perform the commands offered in the assessment and / or intervention 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 exercise groupThe intervention will consist of a half-squat isometric whole-body vibration exercise with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected. | Other | WBV exercise group |
| Sham WBV exercise groupThe intervention will consist of as half-squat isometric exercise , but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation. | Other | Sham WBV exercise group |
Primary outcome
Change in average power measured through isokinetic dynamometer
Time frame: Baseline and immediately after the intervention protocol.
Measured through isokinetic dynamometry. The analyzed variable will be average power (in watts).
5 secondary outcomes
Change in Muscle activation measured through surface electromyography
Time frame: Baseline and immediately after the intervention protocol.
Change in Balance measured through baropodometry
Time frame: Baseline and immediately after the intervention protocol .
Change in peak torque normalized by body weight measured through isokinetic dynamometer
Time frame: Baseline and immediately after the intervention protocol.
Change in total work measured through isokinetic dynamometer
Time frame: Baseline and immediately after the intervention protocol.
Change in peak torque measured through isokinetic dynamometer
Time frame: Baseline and immediately after the intervention protocol.
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 18 Jun 2019.
- 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.
Daniel T Borges, MS principal investigator
Universidade Federal do Rio Grande do Norte
Lidiane C Bulhões, Esp principal investigator
Universidade Federal do Rio Grande do Norte
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 exercise group in people with Neuromuscular Performance and Balance, run by Universidade Federal do Rio Grande do Norte 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 9 inclusion and 3 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 18 Jun 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 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. Some participants in this study may receive a placebo. 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?
Change in average power measured through isokinetic dynamometer (time frame: Baseline and immediately after the intervention protocol.). 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 18 Jun 2019.