OsteoporosisNCT04259697
Effects of Clinical Pilates and Whole Body Vibration Exercises in Postmenopausal Osteoporotic Women
A study testing Clinical pilates and Whole body vibration in people with Osteoporosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women on strength, flexibility, balance, bone turnover markers and quality of life. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Clinical pilates and Whole body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2018to 15 May 2020
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the postmenopausal period
- Having body mass index equal to or greater than 18,5 kg/m²
- A lack of regular exercise
- Having been diagnosed with osteoporosis
- Having the ability to walk independently
Who cannot join
- Having a cardiopulmonary problem that may prevent participating in exercise programs
- Having kidney stones
- Being diagnosed with diabetes
- Presence of epilepsy
- Having cardiological problems such as arrhythmia, using a pacemaker, hypertension
- Having neurological disorders such as Parkinson, stroke, multiple sclerosis, neuropathy
- Having surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir, 340
About this study
Official title: Comparison of the Effects of Clinical Pilates and Whole Body Vibration Exercises on Strength, Flexibility, Balance, Bone Turnover Markers and Quality of Life in Postmenopausal Osteoporotic Women
The aim is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women on strength, flexibility, balance, bone turnover markers and quality of life.
Read the detailed description
The aim of this study is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women in terms of strength, flexibility, balance, bone turnover markers and quality of life. Thirty-four women who are diagnosed with postmenopausal osteoporosis will be recruited into the study. Participants will be divided into two groups: (1) clinical pilates group, (2) vibration exercises group. Exercise programs will be performed two times per week for twelve weeks. The strength of the extensor muscles of the hip, knee, back, elbow will be measured with a hand-held dynamometer. Flexibility will be assessed measuring the fingertip-to-floor distance in flexion and lateral bending. The balance performance will be assessed using the timed up and go test, Tetrax fall index and the maximum hold time on unipedal stance and on tandem stance. The short form-12 questionnaire will be used to assess the quality of life. Also, bone turnover markers will be measured. All assessments will be performed before and after exercise programs.
- Conditions
- Osteoporosis
- Being tested
- Clinical pilates, Whole body vibration
- Keywords
- postmenopausal osteoporosis, clinical pilates, whole body vibration, bone turnover markers, strength, flexibility, balance, quality of life
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pilatesOther
Clinical pilates exercises will be performed progressively. The duration of each exercise session will be an average of 40 minutes initially and then will be increased to 60 minutes as the program progress.
Whole body vibrationOther
Whole body vibration exercises will be performed using the Power Plate pro5 AIRdaptive machine.The duration of each exercise session will be an average of 20 minutes initially and then will be increased to 30 minutes as the program progress.
| Study group | Role | What they receive |
|---|---|---|
| Clinical pilates | Experimental | Exercises will be performed two times per week for twelve weeks. Receives: Other: Clinical pilates |
| Whole body vibration | Experimental | Exercises will be performed two times per week for twelve weeks. Receives: Other: Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.
Measured: Change in strength measures from baseline to twelve weeks
Flexibility
Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.
Measured: Change in flexibility measures from baseline to twelve weeks
Timed up and go test
Timed up and go test will be used to assess dynamic balance.
Measured: Change in Timed up and go test from baseline to twelve weeks
The maximum hold time on unipedal stance and on tandem stance.
The maximum hold time will be calculated to assess static balance.
Measured: Change in the maximum hold time from baseline to twelve weeks
Tetrax fall index
Tetrax fall index will be calculated to determine fall risk.
Measured: Change in Tetrax fall index from baseline to twelve weeks
The short form-12 questionnaire
The short form-12 questionnaire will be used to assess quality of life. The total score can range from 0 to 100. Lower SF-12 score indicated poorer physical and mental health.
Measured: Change in quality of life measure from baseline to twelve weeks
Dual-energy X-ray absorptiometry of hip and lumbar spine
Dual-energy X-ray absorptiometry of hip and lumbar spine will be measured to assess bone density.
Measured: Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks
Plasma sclerostin concentration
Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.
Measured: Change in plasma sclerostin concentration from baseline to twelve weeks
Urinary deoxypyridinoline
Urinary deoxypyridinoline level will be measured to assess bone resorption.
Measured: Change in urinary deoxypyridinoline level from baseline to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start15 Jan 2018
- Primary completion15 Apr 2020 (estimated)
- Study completion15 May 2020 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A controlled study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Ece KORKMAZ, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259697
- Sponsor's protocol ID
- Ece Korkmaz
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Clinical Pilates and Whole Body Vibration Exercises on Strength, Flexibility, Balance, Bone Turnover Markers and Quality of Life in Postmenopausal Osteoporotic Women
- ClinicalTrials.gov ID
- NCT04259697
- Acronym / sponsor ID
- Ece Korkmaz
- Conditions
- Osteoporosis
- Keywords
- postmenopausal osteoporosis, clinical pilates, whole body vibration, bone turnover markers, strength, flexibility, balance, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 6 Feb 2020 (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 aim is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women on strength, flexibility, balance, bone turnover markers and quality of life.
Detailed description
The aim of this study is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women in terms of strength, flexibility, balance, bone turnover markers and quality of life. Thirty-four women who are diagnosed with postmenopausal osteoporosis will be recruited into the study. Participants will be divided into two groups: (1) clinical pilates group, (2) vibration exercises group. Exercise programs will be performed two times per week for twelve weeks. The strength of the extensor muscles of the hip, knee, back, elbow will be measured with a hand-held dynamometer. Flexibility will be assessed measuring the fingertip-to-floor distance in flexion and lateral bending. The balance performance will be assessed using the timed up and go test, Tetrax fall index and the maximum hold time on unipedal stance and on tandem stance. The short form-12 questionnaire will be used to assess the quality of life. Also, bone turnover markers will be measured. All assessments will be performed before and after exercise programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A controlled study
| Arm | Type | Receives |
|---|---|---|
| Clinical pilates | Experimental | Other: Clinical pilatesExercises will be performed two times per week for twelve weeks. |
| Whole body vibration | Experimental | Other: Whole body vibrationExercises will be performed two times per week for twelve weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being in the postmenopausal period
- Having body mass index equal to or greater than 18,5 kg/m²
- A lack of regular exercise
- Having been diagnosed with osteoporosis
- Having the ability to walk independently
Key exclusion criteria (7 listed)
- Having a cardiopulmonary problem that may prevent participating in exercise programs
- Having kidney stones
- Being diagnosed with diabetes
- Presence of epilepsy
- Having cardiological problems such as arrhythmia, using a pacemaker, hypertension
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 |
|---|---|---|
| Clinical pilatesClinical pilates exercises will be performed progressively. The duration of each exercise session will be an average of 40 minutes initially and then will be increased to 60 minutes as the program progress. | Other | Clinical pilates |
| Whole body vibrationWhole body vibration exercises will be performed using the Power Plate pro5 AIRdaptive machine.The duration of each exercise session will be an average of 20 minutes initially and then will be increased to 30 minutes as the program progress. | Other | Whole body vibration |
Primary outcome
Strength
Time frame: Change in strength measures from baseline to twelve weeks
The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.
Flexibility
Time frame: Change in flexibility measures from baseline to twelve weeks
Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.
Timed up and go test
Time frame: Change in Timed up and go test from baseline to twelve weeks
Timed up and go test will be used to assess dynamic balance.
The maximum hold time on unipedal stance and on tandem stance.
Time frame: Change in the maximum hold time from baseline to twelve weeks
The maximum hold time will be calculated to assess static balance.
Tetrax fall index
Time frame: Change in Tetrax fall index from baseline to twelve weeks
Tetrax fall index will be calculated to determine fall risk.
The short form-12 questionnaire
Time frame: Change in quality of life measure from baseline to twelve weeks
The short form-12 questionnaire will be used to assess quality of life. The total score can range from 0 to 100. Lower SF-12 score indicated poorer physical and mental health.
Dual-energy X-ray absorptiometry of hip and lumbar spine
Time frame: Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks
Dual-energy X-ray absorptiometry of hip and lumbar spine will be measured to assess bone density.
Plasma sclerostin concentration
Time frame: Change in plasma sclerostin concentration from baseline to twelve weeks
Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.
Urinary deoxypyridinoline
Time frame: Change in urinary deoxypyridinoline level from baseline to twelve weeks
Urinary deoxypyridinoline level will be measured to assess bone resorption.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pilates and Whole body vibration in people with Osteoporosis, run by Dokuz Eylul University 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 5 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. 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?
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?
Strength (time frame: Change in strength measures from baseline to twelve weeks). The study lists 9 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 6 Feb 2020.