OsteoporosisNCT05182281
The Effect of Horizontal Whole-body Vibration Therapy in Post-menopausal Women
A study testing Whole Body Vibration and Infrared Therapy, Infrared Therapy and Classical Treatment in people with Osteoporosis and Whole Body Vibration, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Osteoporosis is an important public health issue that may result in a high fracture risk in the elderly population. There is general consensus that physical exercise decreases the risk of osteoporotic fractures by reducing the risk of falls and increasing bone strength. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Osteoporosis, Whole Body Vibration
- What is being tested?
- Whole Body Vibration and Infrared Therapy, Infrared Therapy and Classical Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2015to 1 Aug 2015
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal female patients
- Aged 45-65 years
- L2-L4 and/or femoral neck BMD T-scores of -2.5 to-3.
Who cannot join
- Osteoporotic fractures
- Metabolic bone disease
- Hyperparathyroidism
- Presence of hyperthyroidism
- History of steroids or current use of steroids
- History of bisphosphonate consumption over the previous year
Show all 23Show fewer
- Women with lumbar disk herniation, spondylolisthesis or narrow spinal canal
- Conditions that constitute a contraindication for vibration therapy;
- Kidney stones
- Gallstones
- Pregnancy
- Epilepsy
- Cancer
- Pacemaker
- Treatment of orthostatic hypotension
- Recent implants (joint, cochlear, or corneal)
- Recent surgery
- Recent intrauterine device
- Acute thrombosis or hernia
- Acute rheumatoid arthritis
- Serious cardiovascular event
- Diabetes
- Migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Horizontal Whole-body Vibration Therapy on Bone, Quality of Life, Pain, and Balance in Post-menopausal Women
Osteoporosis is an important public health issue that may result in a high fracture risk in the elderly population. There is general consensus that physical exercise decreases the risk of osteoporotic fractures by reducing the risk of falls and increasing bone strength. Although long-term high-intensity exercise programs have been shown to be successful in early post-menopausal women, a high-intensity exercise program appears to be less attractive to older post-menopausal women and may cause a lack of compliance in the long term and result in injury. Some studies have described falls and fractures as side effects of exercise.Whole-body vibration (WBV) therapy is an easy-to-apply alternative therapy for those who do not wish to initiate or continue pharmacological treatments and cannot perform high-impact exercises and is associated with high patient compliance. WBV therapy is among the promising new interventions for the prevention and treatment of osteoporosis and is defined as mechanical vibration applied in a standing or supine position without any restrictions on frequency (hertz), amplitude (millimeters), magnitude (vibration acceleration due to gravity, g) and cumulative WBV dose. The evidence obtained from animal studies have shown that WBV can be an effective method for increasing bone mass and improving bone structure and strength. Some human studies have shown that WBV can positively affect BMD and improve neuromuscular parameters associated with falls in post-menopausal women.Small changes in posture can have a significant effect on the extent to which a plantar-based mechanical stimulus is actually transmitted to the spine or hip; the stimulus is likely to be weakened by the inevitable changes in posture, which occur due to aging and osteoporosis. For these reasons, we aimed to examine the effect of high frequency and low-magnitude horizontal vibration therapy in post-menopausal women without being affected by posture in the present study.
Read the detailed description
In this prospective, randomized controlled 3-month study, 185 post-menopausal women who were diagnosed with osteoporosis and followed up in our outpatient clinic based on the osteoporosis diagnostic criteria by the World Health Organization were analyzed.According to the inclusion and exclusion criteria, 60 patients were included in the study.
The patients included in the study were randomized by the co-researcher into 3 groups of 20 patients each according to the random numbers table. Group 1 received WBV and infrared therapy for 20 minutes per session, 2 days a week for 3 months. Group 2 received only infrared therapy for 20 minutes, 2 days a week for 3 months, in the same bed system. The patients were placed in the supine position with the whole body in contact with the platform/bed during the treatment. In terms of compliance with the WBV therapy, the frequency was increased to 30 Hz in the first week, 40 Hz in the second week, 50 Hz in the third week, and 60 Hz in the fourth week and administered for a total of 20 minutes. Subsequent sessions continued with 60 Hz. The acceleration value administered by the device was 2.0-4.0 m/s², and the amplitude of the applied vibration in the vertical direction was 0.5-2.0 mm.Infrared therapy at a wavelength of 550-950 nm was applied to both groups of patients by means of infrared pads on the bed during the treatment.Group 3 did not receive any treatment. Patients in all 3 groups continued their treatment with 1000 mg Ca and 880 IU vitamin D. The patients were called every week by phone to check whether they were complying with the treatment or not.Bone mineral density (BMD) of the lumbar and femoral regions of all the patients was measured using dual energy x-ray absorptiometry. In addition, osteocalcin and hydroxyproline values were measured. Quality of life was assessed using the Short Form-36 questionnaire, pain was assessed using the visual analog scale, and balance was assessed based on the participants' performance in the Berg Balance test.The scales were applied at the beginning and at the end of the treatment.
- Conditions
- Osteoporosis, Whole Body Vibration
- Being tested
- Whole Body Vibration and Infrared Therapy, Infrared Therapy, Classical Treatment
- Keywords
- Osteoporosis, Whole-body vibration, Bone mineral density, Quality of life
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration and Infrared TherapyDevice
Patients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm. Whole body vibration and infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device.
Infrared TherapyDevice
Patients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm.Infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device.
Classical TreatmentOther
1000 mg Ca and 880 IU vitamin D treatment were given
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration and Infrared Therapy Group | Experimental | Patients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given. Receives: Device: Whole Body Vibration and Infrared Therapy |
| Infrared Therapy Group | Active comparator | Patients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given. Receives: Device: Infrared Therapy |
| Classical Treatment Group | Other | 1000 mg Ca and 880 IU vitamin D treatment were given. Receives: Other: Classical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Density
BMD (g/cm²) of the lumbar, femoral neck, and entire femoral regions of all patients was measured at the onset and end of the treatment using dual energy x-ray absorptiometry (General Electric LUNAR Prodigy Advance).
Measured: 3 months
Bone Turnover Markers
Serum samples were taken from all patients between 08:00 and 10:00 in the morning after 12 hours of fasting. Urine samples were analyzed in the first morning urine. We checked the values of osteocalcin (OC) as a bone formation marker and hydroxyproline/creatinine values as a bone resorption marker.
Measured: 3 months
The Short Form-36
The Short Form-36 (SF-36) is a widely used health-related quality of life scale. It is not specific to any age, disease, or treatment group. It includes general health concepts. It is a questionnaire containing 36 questions in 8 subscales. SF-36 scale can be examined under 2 main sections as physical and mental health. Patients are scored out of 100 points in the SF-36 scale and the scores obtained vary between 0 and 100 points for each component. High scores on this scale indicate a better level of health, whereas low scores indicate deterioration of health.
Measured: 3 months
Visual analog scale
Pain was evaluated according to the visual analog scale (0: no pain; 10 very severe pain). They were asked to describe their back pain on the scale choosing a number from 0 to 10 (10-cm VAS).
Measured: 3 months
Berg Balance Test
Berg Balance test (BBT) assesses whether people can maintain their balance during 14 different activities. The level of competence in the activity for each item is scored between 0 and 4 with 0 indicating the lowest score (incapable of doing) and 4 indicating the highest score (doing it independently and safely). The maximum score obtainable is 56. Higher scores indicate better balance .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 May 2015
- Primary completion1 Aug 2015
- Study completion1 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feyza Akan Begoğlu, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182281
- Sponsor's protocol ID
- feyzaakan
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2021
- Last updated
- 10 Jan 2022
- 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 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Horizontal Whole-body Vibration Therapy on Bone, Quality of Life, Pain, and Balance in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT05182281
- Acronym / sponsor ID
- feyzaakan
- Conditions
- Osteoporosis, Whole Body Vibration
- Keywords
- Osteoporosis, Whole-body vibration, Bone mineral density, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 10 Jan 2022 (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.
Osteoporosis is an important public health issue that may result in a high fracture risk in the elderly population. There is general consensus that physical exercise decreases the risk of osteoporotic fractures by reducing the risk of falls and increasing bone strength. Although long-term high-intensity exercise programs have been shown to be successful in early post-menopausal women, a high-intensity exercise program appears to be less attractive to older post-menopausal women and may cause a lack of compliance in the long term and result in injury. Some studies have described falls and fractures as side effects of exercise.Whole-body vibration (WBV) therapy is an easy-to-apply alternative therapy for those who do not wish to initiate or continue pharmacological treatments and cannot perform high-impact exercises and is associated with high patient compliance. WBV therapy is among the promising new interventions for the prevention and treatment of osteoporosis and is defined as mechanical vibration applied in a standing or supine position without any restrictions on frequency (hertz), amplitude (millimeters), magnitude (vibration acceleration due to gravity, g) and cumulative WBV dose. The evidence obtained from animal studies have shown that WBV can be an effective method for increasing bone mass and improving bone structure and strength. Some human studies have shown that WBV can positively affect BMD and improve neuromuscular parameters associated with falls in post-menopausal women.Small changes in posture can have a significant effect on the extent to which a plantar-based mechanical stimulus is actually transmitted to the spine or hip; the stimulus is likely to be weakened by the inevitable changes in posture, which occur due to aging and osteoporosis. For these reasons, we aimed to examine the effect of high frequency and low-magnitude horizontal vibration therapy in post-menopausal women without being affected by posture in the present study.
Detailed description
In this prospective, randomized controlled 3-month study, 185 post-menopausal women who were diagnosed with osteoporosis and followed up in our outpatient clinic based on the osteoporosis diagnostic criteria by the World Health Organization were analyzed.According to the inclusion and exclusion criteria, 60 patients were included in the study.
The patients included in the study were randomized by the co-researcher into 3 groups of 20 patients each according to the random numbers table. Group 1 received WBV and infrared therapy for 20 minutes per session, 2 days a week for 3 months. Group 2 received only infrared therapy for 20 minutes, 2 days a week for 3 months, in the same bed system. The patients were placed in the supine position with the whole body in contact with the platform/bed during the treatment. In terms of compliance with the WBV therapy, the frequency was increased to 30 Hz in the first week, 40 Hz in the second week, 50 Hz in the third week, and 60 Hz in the fourth week and administered for a total of 20 minutes. Subsequent sessions continued with 60 Hz. The acceleration value administered by the device was 2.0-4.0 m/s², and the amplitude of the applied vibration in the vertical direction was 0.5-2.0 mm.Infrared therapy at a wavelength of 550-950 nm was applied to both groups of patients by means of infrared pads on the bed during the treatment.Group 3 did not receive any treatment. Patients in all 3 groups continued their treatment with 1000 mg Ca and 880 IU vitamin D. The patients were called every week by phone to check whether they were complying with the treatment or not.Bone mineral density (BMD) of the lumbar and femoral regions of all the patients was measured using dual energy x-ray absorptiometry. In addition, osteocalcin and hydroxyproline values were measured. Quality of life was assessed using the Short Form-36 questionnaire, pain was assessed using the visual analog scale, and balance was assessed based on the participants' performance in the Berg Balance test.The scales were applied at the beginning and at the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration and Infrared Therapy Group | Experimental | Device: Whole Body Vibration and Infrared TherapyPatients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given. |
| Infrared Therapy Group | Active comparator | Device: Infrared TherapyPatients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given. |
| Classical Treatment Group | Other | Other: Classical Treatment1000 mg Ca and 880 IU vitamin D treatment were given. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-menopausal female patients
- Aged 45-65 years
- L2-L4 and/or femoral neck BMD T-scores of -2.5 to-3.
Key exclusion criteria (23 listed)
- Osteoporotic fractures
- Metabolic bone disease
- Hyperparathyroidism
- Presence of hyperthyroidism
- History of steroids or current use of steroids
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 |
|---|---|---|
| Whole Body Vibration and Infrared TherapyPatients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm. Whole body vibration and infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device. | Device | Whole Body Vibration and Infrared Therapy Group |
| Infrared TherapyPatients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm.Infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device. | Device | Infrared Therapy Group |
| Classical Treatment1000 mg Ca and 880 IU vitamin D treatment were given | Other | Classical Treatment Group |
Primary outcome
Body Mass Density
Time frame: 3 months
BMD (g/cm²) of the lumbar, femoral neck, and entire femoral regions of all patients was measured at the onset and end of the treatment using dual energy x-ray absorptiometry (General Electric LUNAR Prodigy Advance).
Bone Turnover Markers
Time frame: 3 months
Serum samples were taken from all patients between 08:00 and 10:00 in the morning after 12 hours of fasting. Urine samples were analyzed in the first morning urine. We checked the values of osteocalcin (OC) as a bone formation marker and hydroxyproline/creatinine values as a bone resorption marker.
The Short Form-36
Time frame: 3 months
The Short Form-36 (SF-36) is a widely used health-related quality of life scale. It is not specific to any age, disease, or treatment group. It includes general health concepts. It is a questionnaire containing 36 questions in 8 subscales. SF-36 scale can be examined under 2 main sections as physical and mental health. Patients are scored out of 100 points in the SF-36 scale and the scores obtained vary between 0 and 100 points for each component. High scores on this scale indicate a better level of health, whereas low scores indicate deterioration of health.
Visual analog scale
Time frame: 3 months
Pain was evaluated according to the visual analog scale (0: no pain; 10 very severe pain). They were asked to describe their back pain on the scale choosing a number from 0 to 10 (10-cm VAS).
Berg Balance Test
Time frame: 3 months
Berg Balance test (BBT) assesses whether people can maintain their balance during 14 different activities. The level of competence in the activity for each item is scored between 0 and 4 with 0 indicating the lowest score (incapable of doing) and 4 indicating the highest score (doing it independently and safely). The maximum score obtainable is 56. Higher scores indicate better balance .
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 Jan 2022.
- 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.
Feyza Akan Begoğlu principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration and Infrared Therapy, Infrared Therapy and Classical Treatment in people with Osteoporosis and Whole Body Vibration, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 23 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 Jan 2022. 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 Turkey (Türkiye). 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?
Body Mass Density (time frame: 3 months). The study lists 5 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 10 Jan 2022.