- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460388
Pilates Plus Whole-Body Vibration in Postmenopausal Women (Pilates_WBV)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(a) 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.
Exclusion Criteria:
(a) personal decision; (b) adverse events that make participation impossible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates plus WBV
Pilates exercises combined with whole-body vibration.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar spine BMD
Time Frame: From enrollment to the end of treatment, in 6 months
|
Lumbar spine bone mineral density
|
From enrollment to the end of treatment, in 6 months
|
|
Femoral neck BMD
Time Frame: From enrollment to the end of treatment, in 6 months
|
Femoral neck bone mineral density
|
From enrollment to the end of treatment, in 6 months
|
|
Total hip BMD
Time Frame: From enrollment to the end of treatment, in 6 months
|
Total hip bne mineral density
|
From enrollment to the end of treatment, in 6 months
|
|
Trochanter BMD
Time Frame: From enrollment to the end of treatment, in 6 months
|
Trochanter bone mineral density
|
From enrollment to the end of treatment, in 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extensor strength at 60º/s
Time Frame: From enrollment to the end of treatment, in 6 months
|
Peak isokinetic torque of the knee extensor muscles at 60º/s
|
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
|
Peak isokinetic torque of knee flexor muscles at 60º/s
|
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
|
Peak isokinetic torque of knee extensor muscles at 180º/s
|
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
|
Peak isokinetic torque of knee flexor muscles at 180º/s
|
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
|
Bipedal support with eyes open (area - cm2)
|
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
|
Bipedal support with eyes closed (area - cm2)
|
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
|
Semi-tandem support with eyes open (area - cm2)
|
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
|
Semi-tandem support with eyes closed (area - cm2)
|
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
|
Unipedal support with eyes open (area - cm2)
|
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
|
Bipedal support with eyes open (anteroposterior displacement - cm/s)
|
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
|
Bipedal support with eyes closed (anteroposterior displacement - cm/s)
|
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
|
Semi-tandem support with eyes open (anteroposterior displacement - cm/s)
|
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
|
Semi-tandem support with eyes closed (anteroposterior displacement - cm/s)
|
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
|
Unipedal support with eyes open (anteroposterior displacement - cm/s)
|
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
|
Bipedal support with eyes open (medial-lateral displacement - cm/s)
|
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
|
Bipedal support with eyes closed (medial-lateral displacement - cm/s)
|
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
|
Semi-tandem support with eyes open (medial-lateral displacement - cm/s)
|
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
|
Semi-tandem support with eyes closed (medial-lateral displacement - cm/s)
|
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
|
Unipedal support with eyes open (medial-lateral displacement - cm/s)
|
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
|
Physical Functioning Domain
|
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
|
Role-Physical Domain
|
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
|
Bodily Pain Domain
|
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
|
General Health Domain
|
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
|
Vitality Domain
|
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
|
Social Functioning Domain
|
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
|
Role-Emotional Domain
|
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
|
Mental Health Domain
|
From enrollment to the end of treatment, in 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pilates_WBV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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