AgingNCT03030456
Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders
A study testing Power Plate® in people with Aging and Oxidative Stress, run by University of Santa Cruz do Sul.
Trial summary
This study is a randomized clinical trial that has as objective to evaluate the effects of training with a vibratory platform on body composition, muscular strength functional capacity, flexibility and biochemical profile on elderly women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Oxidative Stress
- What is being tested?
- Power Plate®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female aged 60 or older.
- Non-physical activity practicing elderly women.
- Maximum weight of 159 kg.
- BMI between 18 and 39 kg/m².
Who cannot join
- Systemic arterial hypertension, (systolic arterial pressure >140 mmHg or diastolic arterial pressure >90 mmHg).
- Cognitive compromising neutropenia.
- Individual subject to surgical procedures, where bone prosthetics has been implanted or cardiac pacemaker.
- Individuals diagnosed with labyrinthitis, disc hernia, thrombosis,decompensated diabetes or cancer.
- Cognitive deficit.
- Orthopedic deficit which makes participation impossible.
- Persistent discomfort after using the vibratory platform.
- Individuals missing three consecutive training sessions on the vibratory platform.
About this study
Official title: Evaluation of the Effects of Whole Body Vibration Training on Functional Capacity, Muscle Strength, and Biochemical Profile in Elderly Women
This study is a randomized clinical trial that has as objective to evaluate the effects of training with a vibratory platform on body composition, muscular strength functional capacity, flexibility and biochemical profile on elderly women. It will be done in the city of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80 years-old, within the municipal limits and nearby areas selected randomly by a brown envelope in which a note will be stating if they belong to the control or vibratory platform group, in which the participant will be receiving whole body vibrations on the platform. The recruiting will be done by the institution through e-mail or by public call.
Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied, in order to evaluate if they don´t have counterindications for the vibratory platform. They will be evaluated in their general health, socio-economical status, and history of physical activity. Participants will have their doubts cleared about the study, and a written consent will be signed. Before the intervention with whole body vibrations, nutritional and physical activity aspects will be evaluated. The treatment period on the vibratory platform will be of 8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar prehension strength, metabolic basal load, and functional capacity measurements will be taken. Before and after every session on the vibratory platform, heart rate, respiratory rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The interventional procedure will be done with a vibratory platform (Power Plate®, model my7™, UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training, and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the amplitude of 2 mm.
The study aims to contribute with reducing the body mass index and body fat percentage, to improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and flexibility, also obtaining better biochemical profiles after the training period.
Read the detailed description
After evaluating the anamnesis and having the written consent signed and clarified, the elderly women will be evaluated before and after the intervention period of 8 weeks of training on the vibratory platform. First, academics from the nutrition degree of the University of Santa Cruz do Sul (UNISC) will perform nutritional evaluations on the subjects, asking them their 24 hour eating habits, there will not be any interference on the subjects diet, also they will have to keep these habits until the end of the trial. Then there will be a socio-economical indicators evaluation through a questionnaire of socio-economical classification from the Brazilian Association of Research Companies.The evaluation of their level of physical activity will be done by the International Physical Activity Questionnaire. The anthropometrical evaluation will consider height, weight, body mass index, waist circumference, hip circumference, and hip-waist ratio. Body fat percentage, lean mass, and basal metabolic rate will be obtained through bioimpedance (Biodynamics 450, USA), recommending 5 hours fasting prior to the procedure. Biochemical tests will be done collecting blood at the University of Santa Cruz Exercise Biochemistry Laboratory, on the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress evaluation with the Thiobarbituric acid reactive substances (TBARS) test will be done after urine collection once a week, before intervention and immediately after the session. Control group subjects will have urine collected twice: on the day when cards will be handed in and on the last day of evaluations. Physical evaluation will be done in the week prior to the intervention with the vibratory platform and in the last week of treatment, where flexibility through Wells Bank will be evaluated, as well as lower limb muscular strength by the maximum repetitions test, and palmar prehension strength will be obtained through dynamometer. Functional Capacity will be evaluated with the six minute walk test.
The intervention procedure with the vibratory platform (Power Plate®, model my7™, UK) will last 8 weeks, 3 times a week with work periods lasting between 30 seconds and 1 hour and rest periods of 30 seconds to 1 minute with a total session time of 10 to 20 minutes. The individual will be then positioned in orthosis with a knee flexion of a 15° and a foot width distance of 20 cm. A frequency of 35 Hz and an amplitude of 2 mm will be used. The protocol with number of session, time of session, time of vibrations and rest, is as follows: 1st through 6th session, total time of 10 minutes, with 30 seconds of vibration alternated with 1 minute rest; 7th through 12th session, total time of 10 minutes, vibrations and rest time of 1 minute each; 13th trough 18th session, total session time of 15 minutes, vibrations and rest time of 1 minute each, 19th through 24th session, total time of 20 minutes, time of vibration 1 minute and rest time of 30 seconds.
Statistical analysis: This will be done using the Statistical Package for Social Science (Version 23.0 USA) program. To test data normality the investigators will use the Kolmogorov-Smirnov test. Parametric data will be presented in mean and standard deviation and non-parametric data in median and interquartile intervals. The intragroup deltas from the pre and post training periods on the vibratory platform on both groups will be evaluated through Student´s T Test (paired T test or non-parametric equivalent for intergroup comparisons).
To evaluate body composition, metabolic rate, palmar prehension strength, flexibility, muscular strength, distance traveled through the Six minute walking test (6SMWT), biochemical profile and oxidative stress between the groups evaluated pre and post training period, a Student´s T test will be used. Significance level will be p < 0,05.
Sample size: It was based on a previous study by Rees et al. (2008). To detect a difference of 8,9 W/Kg between knee flexion torque pre and post training on the vibratory platform, considering a p value < 0,05, a statistical power of 80% and a 10% loss, 34 subjects will be needed in each group to be evaluated in pre and post training.
- Conditions
- Aging, Oxidative Stress
- Being tested
- Power Plate®
- Keywords
- whole body vibration, Oxidative Stress, Aged, Biochemical profile, muscle strength, flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Plate®Device
Also called Whole Body Vibrations
Training of elderly women with Whole Body Vibrations through the use of a vibratory platform.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Elderly women receiving a list of general health orientations through an 8 week period |
| Power Plate® | Experimental | Power Plate®: training of elderly women Receives: Device: Power Plate® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of whole body vibrations training on Functional Capacity in Elderly Women.
Functional Capacity will be measured through distance traveled with the six minute walk test.
Measured: eight weeks
Effects of whole body vibrations training on Muscle Strength in Elderly Women.
Muscular strength will be measured by the maximum repetitions test.
Measured: eight weeks
Effects of whole body vibrations training on Biochemical Profile in Elderly Women.
Biochemical profile will be measured through blood collection and there will be a result (number) for each one of the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress will be measured through TBARS test, which will present a numerical result.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionJan 2017 (estimated)
- Study completionFeb 2017 (estimated)
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santa Cruz do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greice Raquel Machado, University of Santa Cruz do Sul
- Investigators
- Greice Raquel Machado, Principal investigator, Masters Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030456
- Sponsor's protocol ID
- 57756916.0.0000.5343
- Status last verified
- Jan 2017
- First submitted
- 21 Sep 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Whole Body Vibration Training on Functional Capacity, Muscle Strength, and Biochemical Profile in Elderly Women
- ClinicalTrials.gov ID
- NCT03030456
- Acronym / sponsor ID
- 57756916.0.0000.5343
- Conditions
- Aging, Oxidative Stress
- Keywords
- whole body vibration, Oxidative Stress, Aged, Biochemical profile, muscle strength, flexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Santa Cruz do SulUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 25 Jan 2017 (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 is a randomized clinical trial that has as objective to evaluate the effects of training with a vibratory platform on body composition, muscular strength functional capacity, flexibility and biochemical profile on elderly women. It will be done in the city of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80 years-old, within the municipal limits and nearby areas selected randomly by a brown envelope in which a note will be stating if they belong to the control or vibratory platform group, in which the participant will be receiving whole body vibrations on the platform. The recruiting will be done by the institution through e-mail or by public call.
Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied, in order to evaluate if they don´t have counterindications for the vibratory platform. They will be evaluated in their general health, socio-economical status, and history of physical activity. Participants will have their doubts cleared about the study, and a written consent will be signed. Before the intervention with whole body vibrations, nutritional and physical activity aspects will be evaluated. The treatment period on the vibratory platform will be of 8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar prehension strength, metabolic basal load, and functional capacity measurements will be taken. Before and after every session on the vibratory platform, heart rate, respiratory rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The interventional procedure will be done with a vibratory platform (Power Plate®, model my7™, UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training, and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the amplitude of 2 mm.
The study aims to contribute with reducing the body mass index and body fat percentage, to improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and flexibility, also obtaining better biochemical profiles after the training period.
Detailed description
After evaluating the anamnesis and having the written consent signed and clarified, the elderly women will be evaluated before and after the intervention period of 8 weeks of training on the vibratory platform. First, academics from the nutrition degree of the University of Santa Cruz do Sul (UNISC) will perform nutritional evaluations on the subjects, asking them their 24 hour eating habits, there will not be any interference on the subjects diet, also they will have to keep these habits until the end of the trial. Then there will be a socio-economical indicators evaluation through a questionnaire of socio-economical classification from the Brazilian Association of Research Companies.The evaluation of their level of physical activity will be done by the International Physical Activity Questionnaire. The anthropometrical evaluation will consider height, weight, body mass index, waist circumference, hip circumference, and hip-waist ratio. Body fat percentage, lean mass, and basal metabolic rate will be obtained through bioimpedance (Biodynamics 450, USA), recommending 5 hours fasting prior to the procedure. Biochemical tests will be done collecting blood at the University of Santa Cruz Exercise Biochemistry Laboratory, on the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress evaluation with the Thiobarbituric acid reactive substances (TBARS) test will be done after urine collection once a week, before intervention and immediately after the session. Control group subjects will have urine collected twice: on the day when cards will be handed in and on the last day of evaluations. Physical evaluation will be done in the week prior to the intervention with the vibratory platform and in the last week of treatment, where flexibility through Wells Bank will be evaluated, as well as lower limb muscular strength by the maximum repetitions test, and palmar prehension strength will be obtained through dynamometer. Functional Capacity will be evaluated with the six minute walk test.
The intervention procedure with the vibratory platform (Power Plate®, model my7™, UK) will last 8 weeks, 3 times a week with work periods lasting between 30 seconds and 1 hour and rest periods of 30 seconds to 1 minute with a total session time of 10 to 20 minutes. The individual will be then positioned in orthosis with a knee flexion of a 15° and a foot width distance of 20 cm. A frequency of 35 Hz and an amplitude of 2 mm will be used. The protocol with number of session, time of session, time of vibrations and rest, is as follows: 1st through 6th session, total time of 10 minutes, with 30 seconds of vibration alternated with 1 minute rest; 7th through 12th session, total time of 10 minutes, vibrations and rest time of 1 minute each; 13th trough 18th session, total session time of 15 minutes, vibrations and rest time of 1 minute each, 19th through 24th session, total time of 20 minutes, time of vibration 1 minute and rest time of 30 seconds.
Statistical analysis: This will be done using the Statistical Package for Social Science (Version 23.0 USA) program. To test data normality the investigators will use the Kolmogorov-Smirnov test. Parametric data will be presented in mean and standard deviation and non-parametric data in median and interquartile intervals. The intragroup deltas from the pre and post training periods on the vibratory platform on both groups will be evaluated through Student´s T Test (paired T test or non-parametric equivalent for intergroup comparisons).
To evaluate body composition, metabolic rate, palmar prehension strength, flexibility, muscular strength, distance traveled through the Six minute walking test (6SMWT), biochemical profile and oxidative stress between the groups evaluated pre and post training period, a Student´s T test will be used. Significance level will be p < 0,05.
Sample size: It was based on a previous study by Rees et al. (2008). To detect a difference of 8,9 W/Kg between knee flexion torque pre and post training on the vibratory platform, considering a p value < 0,05, a statistical power of 80% and a 10% loss, 34 subjects will be needed in each group to be evaluated in pre and post training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Elderly women receiving a list of general health orientations through an 8 week period |
| Power Plate® | Experimental | Device: Power Plate®Power Plate®: training of elderly women |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female aged 60 or older.
- Non-physical activity practicing elderly women.
- Maximum weight of 159 kg.
- BMI between 18 and 39 kg/m².
Key exclusion criteria (8 listed)
- Systemic arterial hypertension, (systolic arterial pressure >140 mmHg or diastolic arterial pressure >90 mmHg).
- Cognitive compromising neutropenia.
- Individual subject to surgical procedures, where bone prosthetics has been implanted or cardiac pacemaker.
- Individuals diagnosed with labyrinthitis, disc hernia, thrombosis,decompensated diabetes or cancer.
- Cognitive deficit.
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 |
|---|---|---|
| Power Plate®Also: Whole Body VibrationsTraining of elderly women with Whole Body Vibrations through the use of a vibratory platform. | Device | Power Plate® |
Primary outcome
Effects of whole body vibrations training on Functional Capacity in Elderly Women.
Time frame: eight weeks
Functional Capacity will be measured through distance traveled with the six minute walk test.
Effects of whole body vibrations training on Muscle Strength in Elderly Women.
Time frame: eight weeks
Muscular strength will be measured by the maximum repetitions test.
Effects of whole body vibrations training on Biochemical Profile in Elderly Women.
Time frame: eight weeks
Biochemical profile will be measured through blood collection and there will be a result (number) for each one of the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress will be measured through TBARS test, which will present a numerical result.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
RecruitingObservational study
Westlake Aging Cohort (WeAC)
Aging, Cognition Improvement
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
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.
Greice Raquel Machado principal investigator
Masters Student
Questions about this trial
What is this clinical trial studying?
A study testing Power Plate® in people with Aging and Oxidative Stress, run by University of Santa Cruz do Sul.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Effects of whole body vibrations training on Functional Capacity in Elderly Women. (time frame: eight weeks). The study lists 3 primary outcomes in all. 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 25 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.