Postmenopausal WomenPilates_WBVNCT07460388
Pilates Plus Whole-Body Vibration in Postmenopausal Women
A study testing Pilates plus whole-body vibration in people with Postmenopausal Women, run by Universidade Estadual do Norte do Parana.
Trial summary
This controlled, quasi-experimental clinical trial investigated the effects of a combined Pilates and whole-body vibration (WBV) intervention on bone mineral density (BMD), muscle strength, postural balance, and quality of life in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Pilates plus whole-body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 31 Jul 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no engagement in structured physical exercise for at least six months prior to enrollment; (b) agreement to refrain from participating in any additional physical exercise programs during the study period; (c) ability to perform activities of daily living independently23, 24; (d) presentation of a medical certificate confirming fitness to engage in physical exercise; (e) cognitive status score > 19 on the Mini-Mental State Examination25; and (f) no use of medications aimed at increasing BMD or muscle mass within the previous 12 months.
Who cannot join
- personal decision; (b) adverse events that make participation impossible.
About this study
Official title: Pilates Plus Whole-body Vibration on Bone Mass, Muscle Strength, Balance and Quality of Life in Postmenopausal Women
This controlled, quasi-experimental clinical trial investigated the effects of a combined Pilates and whole-body vibration (WBV) intervention on bone mineral density (BMD), muscle strength, postural balance, and quality of life in postmenopausal women. Fifteen women aged 50-71 years initially served as a historical control group in a previous study. After completion of that protocol, ten of these participants underwent a 26-week combined intervention consisting of supervised Pilates exercises and WBV performed three times per week.
BMD was assessed using dual-energy X-ray absorptiometry (DXA). Peak torque of the lower limbs was measured by isokinetic dynamometry. Postural balance was evaluated using a force platform, and quality of life was assessed using the Short Form-36 (SF-36) questionnaire. Outcomes obtained after the combined intervention were compared with those from the historical control phase.
- Conditions
- Postmenopausal Women
- Being tested
- Pilates plus whole-body vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates plus whole-body vibrationOther
The intervention consisted of a combined protocol integrating supervised mat-based Pilates exercises with whole-body vibration (WBV) performed on a side-alternating vibrating platform. Sessions were conducted three times per week for 26 weeks. Each session included structured Pilates exercises targeting core stability, postural alignment, and lower-limb strengthening, immediately followed by WBV exposure with controlled frequency and amplitude parameters.
This combined protocol differs from previous interventions conducted in the same population, in which Pilates and WBV were applied separately. The present study specifically investigated the potential additive or synergistic effects of simultaneously implementing both modalities within the same training session, which had not been previously examined in this cohort.
| Study group | Role | What they receive |
|---|---|---|
| Pilates plus WBV | Experimental | Pilates exercises combined with whole-body vibration. Receives: Other: Pilates plus whole-body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine BMD
Lumbar spine bone mineral density
Measured: From enrollment to the end of treatment, in 6 months
Femoral neck BMD
Femoral neck bone mineral density
Measured: From enrollment to the end of treatment, in 6 months
Total hip BMD
Total hip bne mineral density
Measured: From enrollment to the end of treatment, in 6 months
Trochanter BMD
Trochanter bone mineral density
Measured: From enrollment to the end of treatment, in 6 months
Secondary outcomes (27)
Knee extensor strength at 60º/s
Peak isokinetic torque of the knee extensor muscles at 60º/s
Measured: From enrollment to the end of treatment, in 6 months
Knee flexor strength at 60º/s
Peak isokinetic torque of knee flexor muscles at 60º/s
Measured: From enrollment to the end of treatment, in 6 months
Knee extensor strength 180º/s
Peak isokinetic torque of knee extensor muscles at 180º/s
Measured: From enrollment to the end of treatment, in 6 months
Knee flexor strength 180º/s
Peak isokinetic torque of knee flexor muscles at 180º/s
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (area - cm2)
Bipedal support with eyes open (area - cm2)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (area - cm2)
Bipedal support with eyes closed (area - cm2)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (area - cm2)
Semi-tandem support with eyes open (area - cm2)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (area - cm2)
Semi-tandem support with eyes closed (area - cm2)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (area - cm2)
Unipedal support with eyes open (area - cm2)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (anteroposterior displacement - cm/s)
Bipedal support with eyes open (anteroposterior displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (anteroposterior displacement - cm/s)
Bipedal support with eyes closed (anteroposterior displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (anteroposterior displacement - cm/s)
Semi-tandem support with eyes open (anteroposterior displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (anteroposterior displacement - cm/s)
Semi-tandem support with eyes closed (anteroposterior displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (anteroposterior displacement - cm/s)
Unipedal support with eyes open (anteroposterior displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (medial-lateral displacement - cm/s)
Bipedal support with eyes open (medial-lateral displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (medial-lateral displacement - cm/s)
Bipedal support with eyes closed (medial-lateral displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (medial-lateral displacement - cm/s)
Semi-tandem support with eyes open (medial-lateral displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (medial-lateral displacement - cm/s)
Semi-tandem support with eyes closed (medial-lateral displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (medial-lateral displacement - cm/s)
Unipedal support with eyes open (medial-lateral displacement - cm/s)
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Physical Functioning
Physical Functioning Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Role-Physical
Role-Physical Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Bodily Pain
Bodily Pain Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - General Health
General Health Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Vitality
Vitality Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Social Functioning
Social Functioning Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Role-Emotional
Role-Emotional Domain
Measured: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Mental Health
Mental Health Domain
Measured: From enrollment to the end of treatment, in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start5 Jan 2017
- Primary completion25 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study was designed as a single-group interventional trial with comparison to a historical control phase. Participants previously enrolled as a control group in an earlier study underwent a 26-week combined intervention consisting of supervised Pilates exercises and whole-body vibration (WBV), performed three times per week. Outcomes obtained after the combined intervention were compared with data collected during the prior control period, in which participants did not receive structured exercise intervention. The combined intervention phase was conducted after completion of the original protocol and was implemented to investigate the potential additive effects of Pilates and WBV.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do Norte do Parana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Goncalves de Oliveira, Universidade Estadual do Norte do Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460388
- Sponsor's protocol ID
- Pilates_WBV
- Acronym
- Pilates_WBV
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Plus Whole-body Vibration on Bone Mass, Muscle Strength, Balance and Quality of Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07460388
- Acronym / sponsor ID
- Pilates_WBV / Pilates_WBV
- Conditions
- Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Estadual do Norte do ParanaUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 10 Mar 2026 (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.
This controlled, quasi-experimental clinical trial investigated the effects of a combined Pilates and whole-body vibration (WBV) intervention on bone mineral density (BMD), muscle strength, postural balance, and quality of life in postmenopausal women. Fifteen women aged 50-71 years initially served as a historical control group in a previous study. After completion of that protocol, ten of these participants underwent a 26-week combined intervention consisting of supervised Pilates exercises and WBV performed three times per week.
BMD was assessed using dual-energy X-ray absorptiometry (DXA). Peak torque of the lower limbs was measured by isokinetic dynamometry. Postural balance was evaluated using a force platform, and quality of life was assessed using the Short Form-36 (SF-36) questionnaire. Outcomes obtained after the combined intervention were compared with those from the historical control phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was designed as a single-group interventional trial with comparison to a historical control phase. Participants previously enrolled as a control group in an earlier study underwent a 26-week combined intervention consisting of supervised Pilates exercises and whole-body vibration (WBV), performed three times per week. Outcomes obtained after the combined intervention were compared with data collected during the prior control period, in which participants did not receive structured exercise intervention. The combined intervention phase was conducted after completion of the original protocol and was implemented to investigate the potential additive effects of Pilates and WBV.
| Arm | Type | Receives |
|---|---|---|
| Pilates plus WBV | Experimental | Other: Pilates plus whole-body vibrationPilates exercises combined with whole-body vibration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no engagement in structured physical exercise for at least six months prior to enrollment; (b) agreement to refrain from participating in any additional physical exercise programs during the study period; (c) ability to perform activities of daily living independently23, 24; (d) presentation of a medical certificate confirming fitness to engage in physical exercise; (e) cognitive status score > 19 on the Mini-Mental State Examination25; and (f) no use of medications aimed at increasing BMD or muscle mass within the previous 12 months.
Key exclusion criteria (1 listed)
- personal decision; (b) adverse events that make participation impossible.
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 |
|---|---|---|
| Pilates plus whole-body vibrationThe intervention consisted of a combined protocol integrating supervised mat-based Pilates exercises with whole-body vibration (WBV) performed on a side-alternating vibrating platform. Sessions were conducted three times per week for 26 weeks. Each session included structured Pilates exercises targeting core stability, postural alignment, and lower-limb strengthening, immediately followed by WBV exposure with controlled frequency and amplitude parameters. This combined protocol differs from previous interventions conducted in the same population, in which Pilates and WBV were applied separately. The present study specifically investigated the potential additive or synergistic effects of simultaneously implementing both modalities within the same training session, which had not been previously examined in this cohort. | Other | Pilates plus WBV |
Primary outcome
Lumbar spine BMD
Time frame: From enrollment to the end of treatment, in 6 months
Lumbar spine bone mineral density
Femoral neck BMD
Time frame: From enrollment to the end of treatment, in 6 months
Femoral neck bone mineral density
Total hip BMD
Time frame: From enrollment to the end of treatment, in 6 months
Total hip bne mineral density
Trochanter BMD
Time frame: From enrollment to the end of treatment, in 6 months
Trochanter bone mineral density
27 secondary outcomes
Knee extensor strength at 60º/s
Time frame: From enrollment to the end of treatment, in 6 months
Knee flexor strength at 60º/s
Time frame: From enrollment to the end of treatment, in 6 months
Knee extensor strength 180º/s
Time frame: From enrollment to the end of treatment, in 6 months
Knee flexor strength 180º/s
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (area - cm2)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (area - cm2)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (area - cm2)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (area - cm2)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (area - cm2)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (anteroposterior displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (anteroposterior displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (anteroposterior displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (anteroposterior displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (anteroposterior displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes open (medial-lateral displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with bipedal support and eyes closed (medial-lateral displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes open (medial-lateral displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with semi-tandem support and eyes closed (medial-lateral displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Static balance with unipedal support and eyes open (medial-lateral displacement - cm/s)
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Physical Functioning
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Role-Physical
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Bodily Pain
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - General Health
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Vitality
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Social Functioning
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Role-Emotional
Time frame: From enrollment to the end of treatment, in 6 months
Quality of life (SF-36) - Mental Health
Time frame: From enrollment to the end of treatment, in 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 10 Mar 2026.
- Individual participant dataSharing planned: Yes. The data will be available in a public repository.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates plus whole-body vibration in people with Postmenopausal Women, run by Universidade Estadual do Norte do Parana.
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 1 inclusion and 1 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 Mar 2026. 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?
Lumbar spine BMD (time frame: From enrollment to the end of treatment, in 6 months). The study lists 4 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 Mar 2026.