Osteoporosis, PostmenopausalNCT03910348
Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women
A study testing Whole-body vibration exercise and High-impact exercise in people with Osteoporosis, Postmenopausal and Exercise Therapy, run by Istanbul University.
Trial summary
We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Exercise Therapy
- What is being tested?
- Whole-body vibration exercise and High-impact exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2011
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 40-65 years old
- Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
- Serum 25(OH)vitamin D level ≥ 30 ng/ml.
Who cannot join
- The use of any medications and/or disease that affect bone metabolism
- Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
- Presence of an osteoporotic fracture
- Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
- Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
- Body mass index ≥35 kg/m²
- Thrombosis history
About this study
Official title: Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women
We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms
Read the detailed description
Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another.
Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.
- Conditions
- Osteoporosis, Postmenopausal, Exercise Therapy
- Being tested
- Whole-body vibration exercise, High-impact exercise
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration exerciseDevice
The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA).
High-impact exerciseOther
In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration exercise | Experimental | The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting (2-4mm peak to peak) on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Each patient received the vibrations under supervision using five different static positions: squat, deep squat, widestep squat, lunge, and hands-front lunge. The exercise programs for each experimental groups consisted of 20 to 60-minute sessions on three days per week for 24 weeks, and they were performed under the supervision. Receives: Device: Whole-body vibration exercise |
| High-impact exercise | Experimental | Depending on their individual calcium and vitamin D intakes, each patient advised to receive supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. Receives: Other: High-impact exercise |
| Control | No intervention | Depending on their individual calcium and vitamin D intakes, each patient received supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. The demographic characteristics of the participants were obtained at the baseline assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Bone Mineral Density at 6 months
The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry
Measured: baseline and 6 month
Secondary outcomes (6)
Change from Baseline Bone Formation Marker at 3-months and 6-months
The serum osteocalcin (OC) level
Measured: baseline, 3-month, 6-month
Change from Baseline Bone Resorption Marker- at 3-months and 6-months
The serum C-terminal telopeptide of type I collagen (CTx) levels
Measured: baseline, 3-month, 6-month
Change from Baseline Fall risk at 3-months and 6-months
A computerized static posturography device was used to measure the fall index
Measured: baseline, 3-month, 6-month
Change from Baseline Functional Balance at 3-months and 6-months
Timed Up and Go (TUG) test
Measured: baseline, 3-month, 6-month
Change from Baseline Health-related Quality of Life at 6 months
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Measured: baseline, 6-month
Change from Baseline Depressive Symptoms at 6 months
Beck Depression Inventory
Measured: baseline, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study startJan 2010
- Primary completionMay 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Ilke Sen, Istanbul University
- Investigators
- Ekin I Sen, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910348
- Sponsor's protocol ID
- IstanbulU-Ekin Sen
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03910348
- Acronym / sponsor ID
- IstanbulU-Ekin Sen
- Conditions
- Osteoporosis, Postmenopausal, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Apr 2019 (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.
We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms
Detailed description
Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another.
Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration exercise | Experimental | Device: Whole-body vibration exerciseThe WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting (2-4mm peak to peak) on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Each patient received the vibrations under supervision using five different static positions: squat, deep squat, widestep squat, lunge, and hands-front lunge. The exercise programs for each experimental groups consisted of 20 to 60-minute sessions on three days per week for 24 weeks, and they were performed under the supervision. |
| High-impact exercise | Experimental | Other: High-impact exerciseDepending on their individual calcium and vitamin D intakes, each patient advised to receive supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. |
| Control | No intervention | –Depending on their individual calcium and vitamin D intakes, each patient received supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. The demographic characteristics of the participants were obtained at the baseline assessment. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women aged 40-65 years old
- Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
- Serum 25(OH)vitamin D level ≥ 30 ng/ml.
Key exclusion criteria (7 listed)
- The use of any medications and/or disease that affect bone metabolism
- Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
- Presence of an osteoporotic fracture
- Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
- Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
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 exerciseThe WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). | Device | Whole body vibration exercise |
| High-impact exerciseIn the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session | Other | High-impact exercise |
Primary outcome
Change from Baseline Bone Mineral Density at 6 months
Time frame: baseline and 6 month
The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry
6 secondary outcomes
Change from Baseline Bone Formation Marker at 3-months and 6-months
Time frame: baseline, 3-month, 6-month
Change from Baseline Bone Resorption Marker- at 3-months and 6-months
Time frame: baseline, 3-month, 6-month
Change from Baseline Fall risk at 3-months and 6-months
Time frame: baseline, 3-month, 6-month
Change from Baseline Functional Balance at 3-months and 6-months
Time frame: baseline, 3-month, 6-month
Change from Baseline Health-related Quality of Life at 6 months
Time frame: baseline, 6-month
Change from Baseline Depressive Symptoms at 6 months
Time frame: baseline, 3-month, 6-month
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 Apr 2019.
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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.
Ekin I Sen principal investigator
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body vibration exercise and High-impact exercise in people with Osteoporosis, Postmenopausal and Exercise Therapy, run by Istanbul University.
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 7 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 Apr 2019. 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?
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 from Baseline Bone Mineral Density at 6 months (time frame: baseline and 6 month). 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 Apr 2019.