Postmenopausal Women
Conditions
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.
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.
Sponsors
Study design
Intervention 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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total hip BMD | From enrollment to the end of treatment, in 6 months | Total hip bne mineral density |
| Trochanter BMD | From enrollment to the end of treatment, in 6 months | Trochanter bone mineral density |
| Lumbar spine BMD | From enrollment to the end of treatment, in 6 months | Lumbar spine bone mineral density |
| Femoral neck BMD | From enrollment to the end of treatment, in 6 months | Femoral neck bone mineral density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static balance with bipedal support and eyes open (area - cm2) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes open (area - cm2) |
| Static balance with bipedal support and eyes closed (area - cm2) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes closed (area - cm2) |
| Static balance with semi-tandem support and eyes open (area - cm2) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes open (area - cm2) |
| Static balance with semi-tandem support and eyes closed (area - cm2) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes closed (area - cm2) |
| Static balance with unipedal support and eyes open (area - cm2) | From enrollment to the end of treatment, in 6 months | Unipedal support with eyes open (area - cm2) |
| Static balance with bipedal support and eyes open (anteroposterior displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes open (anteroposterior displacement - cm/s) |
| Static balance with bipedal support and eyes closed (anteroposterior displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes closed (anteroposterior displacement - cm/s) |
| Static balance with semi-tandem support and eyes open (anteroposterior displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes open (anteroposterior displacement - cm/s) |
| Static balance with semi-tandem support and eyes closed (anteroposterior displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes closed (anteroposterior displacement - cm/s) |
| Static balance with unipedal support and eyes open (anteroposterior displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Unipedal support with eyes open (anteroposterior displacement - cm/s) |
| Static balance with bipedal support and eyes open (medial-lateral displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes open (medial-lateral displacement - cm/s) |
| Static balance with bipedal support and eyes closed (medial-lateral displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Bipedal support with eyes closed (medial-lateral displacement - cm/s) |
| Static balance with semi-tandem support and eyes open (medial-lateral displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes open (medial-lateral displacement - cm/s) |
| Static balance with semi-tandem support and eyes closed (medial-lateral displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Semi-tandem support with eyes closed (medial-lateral displacement - cm/s) |
| Static balance with unipedal support and eyes open (medial-lateral displacement - cm/s) | From enrollment to the end of treatment, in 6 months | Unipedal support with eyes open (medial-lateral displacement - cm/s) |
| Quality of life (SF-36) - Physical Functioning | From enrollment to the end of treatment, in 6 months | Physical Functioning Domain |
| Quality of life (SF-36) - Role-Physical | From enrollment to the end of treatment, in 6 months | Role-Physical Domain |
| Quality of life (SF-36) - Bodily Pain | From enrollment to the end of treatment, in 6 months | Bodily Pain Domain |
| Quality of life (SF-36) - General Health | From enrollment to the end of treatment, in 6 months | General Health Domain |
| Quality of life (SF-36) - Vitality | From enrollment to the end of treatment, in 6 months | Vitality Domain |
| Quality of life (SF-36) - Social Functioning | From enrollment to the end of treatment, in 6 months | Social Functioning Domain |
| Quality of life (SF-36) - Role-Emotional | From enrollment to the end of treatment, in 6 months | Role-Emotional Domain |
| Knee flexor strength at 60º/s | From enrollment to the end of treatment, in 6 months | Peak isokinetic torque of knee flexor muscles at 60º/s |
| Quality of life (SF-36) - Mental Health | From enrollment to the end of treatment, in 6 months | Mental Health Domain |
| Knee extensor strength at 60º/s | From enrollment to the end of treatment, in 6 months | Peak isokinetic torque of the knee extensor muscles at 60º/s |
| Knee extensor strength 180º/s | From enrollment to the end of treatment, in 6 months | Peak isokinetic torque of knee extensor muscles at 180º/s |
| Knee flexor strength 180º/s | From enrollment to the end of treatment, in 6 months | Peak isokinetic torque of knee flexor muscles at 180º/s |