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Clinical Trials/NCT07460388
NCT07460388
Completed
Not Applicable

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

Universidade Estadual do Norte do Parana0 sites10 target enrollmentStarted: January 5, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
10
Primary Endpoint
Lumbar spine BMD

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Pilates plus WBV

Experimental

Pilates exercises combined with whole-body vibration.

Intervention: Pilates plus whole-body vibration (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Static balance with bipedal support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with semi-tandem support and eyes closed (area - cm2)(From enrollment to the end of treatment, in 6 months)
  • Static balance with unipedal support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with bipedal support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with semi-tandem support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with bipedal support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with semi-tandem support and 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)(From enrollment to the end of treatment, in 6 months)
  • Static balance with unipedal support and eyes open (medial-lateral displacement - cm/s)(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Physical Functioning(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Role-Physical(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Bodily Pain(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - General Health(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Vitality(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Social Functioning(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Role-Emotional(From enrollment to the end of treatment, in 6 months)
  • Quality of life (SF-36) - Mental Health(From enrollment to the end of treatment, in 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Raphael Goncalves de Oliveira

Dr

Universidade Estadual do Norte do Parana

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