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Completed

NCT Number: NCT07460388

Pilates Plus Whole-Body Vibration 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.

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Key information

Conditions

Postmenopausal Women

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates plus whole-body vibration

Other

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.

Primary outcomes

  1. Lumbar spine BMD

    Time frame: From enrollment to the end of treatment, in 6 months

    Lumbar spine bone mineral density

  2. Femoral neck BMD

    Time frame: From enrollment to the end of treatment, in 6 months

    Femoral neck bone mineral density

  3. Total hip BMD

    Time frame: From enrollment to the end of treatment, in 6 months

    Total hip bne mineral density

  4. Trochanter BMD

    Time frame: From enrollment to the end of treatment, in 6 months

    Trochanter bone mineral density

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. Quality of life (SF-36) - Physical Functioning

    Time frame: From enrollment to the end of treatment, in 6 months

    Physical Functioning Domain

  21. Quality of life (SF-36) - Role-Physical

    Time frame: From enrollment to the end of treatment, in 6 months

    Role-Physical Domain

  22. Quality of life (SF-36) - Bodily Pain

    Time frame: From enrollment to the end of treatment, in 6 months

    Bodily Pain Domain

  23. Quality of life (SF-36) - General Health

    Time frame: From enrollment to the end of treatment, in 6 months

    General Health Domain

  24. Quality of life (SF-36) - Vitality

    Time frame: From enrollment to the end of treatment, in 6 months

    Vitality Domain

  25. Quality of life (SF-36) - Social Functioning

    Time frame: From enrollment to the end of treatment, in 6 months

    Social Functioning Domain

  26. Quality of life (SF-36) - Role-Emotional

    Time frame: From enrollment to the end of treatment, in 6 months

    Role-Emotional Domain

  27. Quality of life (SF-36) - Mental Health

    Time frame: From enrollment to the end of treatment, in 6 months

    Mental Health Domain

Sponsors and collaborators

Lead sponsor

Universidade Estadual do Norte do Parana

Other

Registry information

Official study title

Pilates Plus Whole-body Vibration on Bone Mass, Muscle Strength, Balance and Quality of Life in Postmenopausal Women

Acronym: Pilates_WBV

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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