OsteoporosisNCT01499186
The Effect of 6 Months of Local Vibration Training in Institutionalized Elderly
A study testing Local Vibration in people with Osteoporosis and Sarcopenia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This randomized controlled intervention study in institutionalized elderly investigates the effect of 6 months of local vibration therapy applied on the thigh and hip on muscle strength, muscle mass, bone density, and functionality. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia
- What is being tested?
- Local Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Feb 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female;
- Above 65 years of age;
- Institutionalized in a nursing home, service flat or cloistered community;
- Not on bone-active agents;
- Approval for participation in the study after a medical screening by a doctor. The general practitioner will also be contacted for approving the participation of the patient;
- Signed informed consent.
Who cannot join
- Musculoskeletal disease;
- Terminal illness, recent myocardial infarction or unstable cardiovascular conditions;
- Participation in resistance training during the past 24 months;
- Metallic implants (e.g. prothesis);
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams Brabant, 3000
About this study
Official title: The Effect of 6 Months of Local Vibration Training of the Thigh and Hip on Muscle Strength, Muscle Mass, Bone Density, Bone Structure and Functionality in Institutionalized Elderly.
This randomized controlled intervention study in institutionalized elderly investigates the effect of 6 months of local vibration therapy applied on the thigh and hip on muscle strength, muscle mass, bone density, and functionality.
Read the detailed description
As the world population ages, osteoporosis (skeletal fragility) and sarcopenia (decline in muscle mass and muscle strength) are becoming increasingly important public health concerns. Both osteoporosis and sarcopenia contribute to an increased fall risk and an increased number of hip and vertebral fractures. Clearly, the clinical and economic consequences of osteoporosis and sarcopenia, and the resulting falls and fractures, call for major efforts to search for efficient and feasible interventions to prevent or reverse bone and muscle loss. The present project is intended to partly meet this need.
Whole Body Vibration (WBV) training might be an efficient training method. During WBV the subject stands on a platform that generates vertical sinusoidal vibrations. These mechanical stimuli are transmitted to the body where they stimulate the bone and reflexive muscle contractions will be generated. In previous studies performed by the same group, the investigators found that WBV training (frequency 30-40Hz, peak acceleration 3-10g) can be seen as an efficient alternative for strength training, both in the young sedentary as well as in the elderly population. Additionally, the investigators were able to show that 6 months vibration training in elderly females resulted in a net benefit of about 1.5% in bone mineral density of the hip compared with controls. Finally, the investigators have recently shown that long-term vibration training results in an increase of quadriceps muscle mass.
From the above it appears that vibration therapy could be a plausible candidate as an efficient combination therapy for elderly subjects at risk for osteoporosis and sarcopenia and, by implication, the therapy might help to reduce the number of falls and fractures. However, many questions regarding vibration as a therapy still need to be answered in order to optimize both the efficacy and safety of its application. The application methods of vibration therapy should be optimized to be applicable in a broader range of subjects as well as to deliver the stimuli more targeted to specific regions of interest. Whole body vibration in its present form (subjects standing on a vibrating platform) is inadequate for a large part of the elderly population (e.g., subjects with osteoarthritis at the knee, wheelchair bound subjects, bedridden subjects). Additionally, the transmission of the vibration stimulus from the feet to the hip during WBV is probably insufficient to provoke optimal adaptations at this level. Delivering the vibration stimuli locally (i.e. more targeted) at those regions at risk for fractures or in need for muscle strengthening might be an efficient alternative application method.
The main aim of this pilot research is to obtain data that should allow the investigators to optimize the efficacy and safety of the vibration excitation pattern as well as to optimize the application method. With the ageing of the world population and the predicted rise in fall and fracture rates, appropriate strategies to combat muscle and bone loss will have far reaching implications in containing future health care expenditure for the elderly and in reducing the need for institutionalized care.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- Local Vibration
- Keywords
- Local vibration, elderly, bone, muscle, functionality
- Medical subject headings
- Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local VibrationOther
Also called Local vibration of muscle and bone
The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators which will be placed on the hip and thigh. The subjects will apply the vibrations by themselves and they will learn how to follow the pre-programmed training program. Training sessions take place 5 times a week, during one year. The physiotherapist and the research assistant will attend the training session 1x/week. Training parameters will vary during the year to create a variable stimulus (frequency 40-80Hz and G-force 0.5-5g). The intervention group will perform all measurements.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There will be no participation in a training program. The control group will perform all measurements. |
| Intervention group | Experimental | The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators. These subjects will perform all measurements. Receives: Other: Local Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density hip (change in bone mineral density hip)
Bone mineral density of the total hip will be determined by dual - energy x - ray absorptiometry (Hologic, Waltham, MA, USA).
Measured: baseline and after 6 months
Secondary outcomes (4)
Functionality (change in functionality)
Functionality will be determined by the modified Physical Performance Test (mPPT). Additionally, the number of falls during the study period and their circumstances will be identified using Fall calendars.
Measured: baseline and 6 months
Physical performance (change in physical performance)
Physical performance will be assessed by the "shuttle walk test" which is a standardized incremental field walking test that provokes a symptom limited maximal performance
Measured: baseline and 6 months
Muscle mass (change in muscle mass)
Muscle mass of the upper leg will be determined by a multislice CT-scan (Siemens Sensation 16) which delivers axial slices of the right upper leg. The midpoint between the medial edge of the greater trochanter and the intercondyloid fossa of the patella was determined, and subsequently a 2 mm-thick axial image (1 mm above and 1 mm below this midpoint) was further analyzed. This procedure was repeated 3 cm above and 3 cm below the midpoint. Muscle tissue area was segmented by using standard Hounsfield Units ranges for skeletal muscle (0-100).
Measured: baseline and 6 months
Muscle strength and muscle power (change in muscle strength and power)
Muscle strength and muscle power of the knee extensors will be measured on an isokinetic dynamometer. Static and dynamic muscle strength will be recorded unilaterally on the Biodex Medical System 3 dynamometer. A standard protocol will be performed twice: isometric strength (120 °, 90° en 30°), isotonic strength with 40%, 20% and 1% of the isometric maximum and isokinetic strength by 60°/s, 180°/s en 240°/s.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Verschueren, PhD, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499186
- Sponsor's protocol ID
- ML7837
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tankisheva E, Bogaerts A, Boonen S, Delecluse C, Jansen P, Verschueren SM. Effects of a Six-Month Local Vibration Training on Bone Density, Muscle Strength, Muscle Mass, and Physical Performance in Postmenopausal Women. J Strength Cond Res. 2015 Sep;29(9):2613-22. doi: 10.1519/JSC.0000000000000895.
PubMed 25992656
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 6 Months of Local Vibration Training of the Thigh and Hip on Muscle Strength, Muscle Mass, Bone Density, Bone Structure and Functionality in Institutionalized Elderly.
- ClinicalTrials.gov ID
- NCT01499186
- Acronym / sponsor ID
- ML7837
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- Local vibration, elderly, bone, muscle, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Dec 2011 (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 randomized controlled intervention study in institutionalized elderly investigates the effect of 6 months of local vibration therapy applied on the thigh and hip on muscle strength, muscle mass, bone density, and functionality.
Detailed description
As the world population ages, osteoporosis (skeletal fragility) and sarcopenia (decline in muscle mass and muscle strength) are becoming increasingly important public health concerns. Both osteoporosis and sarcopenia contribute to an increased fall risk and an increased number of hip and vertebral fractures. Clearly, the clinical and economic consequences of osteoporosis and sarcopenia, and the resulting falls and fractures, call for major efforts to search for efficient and feasible interventions to prevent or reverse bone and muscle loss. The present project is intended to partly meet this need.
Whole Body Vibration (WBV) training might be an efficient training method. During WBV the subject stands on a platform that generates vertical sinusoidal vibrations. These mechanical stimuli are transmitted to the body where they stimulate the bone and reflexive muscle contractions will be generated. In previous studies performed by the same group, the investigators found that WBV training (frequency 30-40Hz, peak acceleration 3-10g) can be seen as an efficient alternative for strength training, both in the young sedentary as well as in the elderly population. Additionally, the investigators were able to show that 6 months vibration training in elderly females resulted in a net benefit of about 1.5% in bone mineral density of the hip compared with controls. Finally, the investigators have recently shown that long-term vibration training results in an increase of quadriceps muscle mass.
From the above it appears that vibration therapy could be a plausible candidate as an efficient combination therapy for elderly subjects at risk for osteoporosis and sarcopenia and, by implication, the therapy might help to reduce the number of falls and fractures. However, many questions regarding vibration as a therapy still need to be answered in order to optimize both the efficacy and safety of its application. The application methods of vibration therapy should be optimized to be applicable in a broader range of subjects as well as to deliver the stimuli more targeted to specific regions of interest. Whole body vibration in its present form (subjects standing on a vibrating platform) is inadequate for a large part of the elderly population (e.g., subjects with osteoarthritis at the knee, wheelchair bound subjects, bedridden subjects). Additionally, the transmission of the vibration stimulus from the feet to the hip during WBV is probably insufficient to provoke optimal adaptations at this level. Delivering the vibration stimuli locally (i.e. more targeted) at those regions at risk for fractures or in need for muscle strengthening might be an efficient alternative application method.
The main aim of this pilot research is to obtain data that should allow the investigators to optimize the efficacy and safety of the vibration excitation pattern as well as to optimize the application method. With the ageing of the world population and the predicted rise in fall and fracture rates, appropriate strategies to combat muscle and bone loss will have far reaching implications in containing future health care expenditure for the elderly and in reducing the need for institutionalized care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There will be no participation in a training program. The control group will perform all measurements. |
| Intervention group | Experimental | Other: Local VibrationThe subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators. These subjects will perform all measurements. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Female;
- Above 65 years of age;
- Institutionalized in a nursing home, service flat or cloistered community;
- Not on bone-active agents;
- Approval for participation in the study after a medical screening by a doctor. The general practitioner will also be contacted for approving the participation of the patient;
Key exclusion criteria (4 listed)
- Musculoskeletal disease;
- Terminal illness, recent myocardial infarction or unstable cardiovascular conditions;
- Participation in resistance training during the past 24 months;
- Metallic implants (e.g. prothesis);
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 |
|---|---|---|
| Local VibrationAlso: Local vibration of muscle and boneThe subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators which will be placed on the hip and thigh. The subjects will apply the vibrations by themselves and they will learn how to follow the pre-programmed training program. Training sessions take place 5 times a week, during one year. The physiotherapist and the research assistant will attend the training session 1x/week. Training parameters will vary during the year to create a variable stimulus (frequency 40-80Hz and G-force 0.5-5g). The intervention group will perform all measurements. | Other | Intervention group |
Primary outcome
Bone mineral density hip (change in bone mineral density hip)
Time frame: baseline and after 6 months
Bone mineral density of the total hip will be determined by dual - energy x - ray absorptiometry (Hologic, Waltham, MA, USA).
4 secondary outcomes
Functionality (change in functionality)
Time frame: baseline and 6 months
Physical performance (change in physical performance)
Time frame: baseline and 6 months
Muscle mass (change in muscle mass)
Time frame: baseline and 6 months
Muscle strength and muscle power (change in muscle strength and power)
Time frame: baseline and 6 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 18 Mar 2014.
- Derived from this study: PubMed 25992656Tankisheva E, Bogaerts A, Boonen S, Delecluse C, Jansen P, Verschueren SM. Effects of a Six-Month Local Vibration Training on Bone Density, Muscle Strength, Muscle Mass, and Physical Performance in Postmenopausal Women. J Strength Cond Res. 2015 Sep;29(9):2613-22. doi: 10.1519/JSC.0000000000000895.
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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.
Sabine Verschueren, PhD, Prof principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Vibration in people with Osteoporosis and Sarcopenia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 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 18 Mar 2014. 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 Belgium. 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?
Bone mineral density hip (change in bone mineral density hip) (time frame: baseline and after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499186, which also lists 1 linked publication.
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 Mar 2014.