NCT07460388

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Lumbar spine BMD

    Lumbar spine bone mineral density

    From enrollment to the end of treatment, in 6 months

  • Femoral neck BMD

    Femoral neck bone mineral density

    From enrollment to the end of treatment, in 6 months

  • Total hip BMD

    Total hip bne mineral density

    From enrollment to the end of treatment, in 6 months

  • Trochanter BMD

    Trochanter bone mineral density

    From enrollment to the end of treatment, in 6 months

Secondary Outcomes (27)

  • Knee extensor strength at 60º/s

    From enrollment to the end of treatment, in 6 months

  • Knee flexor strength at 60º/s

    From enrollment to the end of treatment, in 6 months

  • Knee extensor strength 180º/s

    From enrollment to the end of treatment, in 6 months

  • Knee flexor strength 180º/s

    From enrollment to the end of treatment, in 6 months

  • Static balance with bipedal support and eyes open (area - cm2)

    From enrollment to the end of treatment, in 6 months

  • +22 more secondary outcomes

Study Arms (1)

Pilates plus WBV

EXPERIMENTAL

Pilates exercises combined with whole-body vibration.

Other: Pilates plus whole-body vibration

Interventions

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.

Pilates plus WBV

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (a) personal decision; (b) adverse events that make participation impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

January 5, 2017

Primary Completion

July 25, 2017

Study Completion

July 31, 2017

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The data will be available in a public repository.

Time Frame
Free
Access Criteria
Free
More information