Neuromuscular Performance and BalanceNCT03253042
Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly
A study testing WBV exercise program 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 and chronic 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 program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 1 Dec 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;
Show all 9Show fewer
- 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;
- Miss 2 consecutive sessions during the exercise program.
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 and Chronic 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 and chronic 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) reevaluations. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography), functional performance 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 participate in a program of exercises in the 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 first session, 4 and 8 weeks of training, the volunteers will be submitted to the new evaluations, with the same procedures of the initial evaluation.
- Conditions
- Neuromuscular Performance and Balance
- Being tested
- WBV exercise program, Sham WBV exercise program
- 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 programOther
The intervention will consist of a 8-week whole-body vibration exercise program 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 programOther
The intervention will consist of a 8-week exercise program, 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 program | Experimental | 8-week exercise program associated with the vibratory platform. Each exercise session 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 program |
| Sham WBV exercise program | Sham comparator | 8-week exercise program in which each session 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 program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Performance measured through isokinetic dynamometer
The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.
Measured: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Secondary outcomes (4)
Change in Muscle activation measured through surface electromyography
Measured by surface electromyography
Measured: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Change in Balance measured through baropodometry
Measured by baropodometry
Measured: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Change in Quality of life measured through SF-36 questionnaire
measured by SF-36 questionnaire score
Measured: Baseline, after 4 and 8 weeks of the beginning of exercise program.
Change in Functional mobility measured through Timed up and Go test
measured by Timed up and Go test time
Measured: Baseline, after 4 and 8 weeks of the beginning of exercise program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 May 2017
- Primary completion1 Mar 2018
- Study completion1 Dec 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
- 44 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, MD, Principal investigator, Universidade Federal do Rio Grande do NorteLidiane C Correia, Esp, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253042
- Sponsor's protocol ID
- DL2017
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2017
- Last updated
- 5 Apr 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03253042
- Acronym / sponsor ID
- DL2017
- Conditions
- Neuromuscular Performance and Balance
- Keywords
- Exercise, Vibration, Torque, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 17 Aug 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 and chronic 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) reevaluations. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography), functional performance 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 participate in a program of exercises in the 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 first session, 4 and 8 weeks of training, the volunteers will be submitted to the new evaluations, 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 program | Experimental | Other: WBV exercise program8-week exercise program associated with the vibratory platform. Each exercise session 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 program | Sham comparator | Other: Sham WBV exercise program8-week exercise program in which each session 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 (4 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;
- Miss 2 consecutive sessions during the exercise program.
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 programThe intervention will consist of a 8-week whole-body vibration exercise program 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 program |
| Sham WBV exercise programThe intervention will consist of a 8-week exercise program, 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 program |
Primary outcome
Change in Muscle Performance measured through isokinetic dynamometer
Time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.
4 secondary outcomes
Change in Muscle activation measured through surface electromyography
Time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Change in Balance measured through baropodometry
Time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Change in Quality of life measured through SF-36 questionnaire
Time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
Change in Functional mobility measured through Timed up and Go test
Time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
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 5 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Performance and Balance
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Not yet recruiting
Effects of Virtual Reality Exergaming on Reaction Time, Physical Performance, and Muscle Activity in Children
Neuromuscular Performance, Reaction Time
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
Active, not recruiting
Effects of Blood Flow Restriction Training on Physical Function, Muscle Adaptations, and Performance in Roller Skaters
Athletic Performance Enhancement
Active, not recruiting
Weighted-Vest Versus Bodyweight Plyometric Training in Youth Female Soccer Players
Healthy, Athletic Performance
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, MD principal investigator
Universidade Federal do Rio Grande do Norte
Lidiane C Correia, 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 program 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 4 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 5 Apr 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 Muscle Performance measured through isokinetic dynamometer (time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.). 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 5 Apr 2019.