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Clinical Trials/NCT02769143
NCT02769143
Completed
Not Applicable

Effects of Whole Body Vibration and Pilates Method on Bone Mineral Density in Postmenopausal Women: a Randomized, Controlled, Clinical Trial

Universidade Norte do Paraná1 site in 1 country51 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Mineral Density Quantitative Trait Locus 3
Sponsor
Universidade Norte do Paraná
Enrollment
51
Locations
1
Primary Endpoint
Bone mineral density
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Women in the postmenopausal period suffer hormonal changes that contribute to a number of negative factors to health, such as reduced bone mineral density and loss of muscle mass, which contribute to the increased incidence of falls and consequent risk of fractures. Among the possibilities to alleviate these symptoms are mainly drug treatment and the systematic practice of physical exercise. Exercise stands out for not offering adverse effects. One form of exercise that has been recently investigated is the whole body vibration, another form of exercise well accepted by the population is the Pilates method.

Taking into account the lack of literature on the benefits of vibration training; and also the Pilates method on bone mineral density, muscle strength, flexibility, postural balance, fear of falling and the quality of life of postmenopausal women, explains the importance of this work.

Detailed Description

Women in the postmenopausal period suffer hormonal changes that contribute to a number of negative factors to health, such as reduced bone mineral density and loss of muscle mass, which contribute to the increased incidence of falls and consequent risk of fractures. Among the possibilities to alleviate these symptoms are mainly drug treatment and the systematic and regular physical exercise. However, drug treatment primarily involves hormone replacement therapy, which is associated with increased risk of heart disease, stroke and breast cancer. Thus, exercise stands out for not offering adverse effects, however, when it comes to bone metabolism, it is not yet clear what type of exercise is the most effective for women in the postmenopausal period. One form of physical exercise that has recently been investigated is the whole-body vibration (WBV), characterized by individual placement on a vibrating plate capable of transmitting vertical acceleration for the musculoskeletal system, however, the intensity (frequency and magnitude) ideal to allow increased bone metabolism has not been established and remain controversial. Other forms of exercise have been recommended for postmenopausal women, such as those of muscular endurance. Exercises involving strength training, using weight can contribute to the improvement of bone mineral density of women in the postmenopausal period. Another form of exercise that also offers endurance is the Pilates method. However, the effects of this technique on bone mineral density, has not been investigated, despite having shown potential contribution on the variables pain, functional capacity and quality of life in postmenopausal women. This study is justified because there are still shortages of literature and evidence about the benefits of vibration training; and also Pilates, on bone mineral density in postmenopausal women. There are also still little information about how much vibration training can influence muscle strength, flexibility, postural balance, fear of falling and the population's quality of life in question.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Universidade Norte do Paraná
Responsible Party
Principal Investigator
Principal Investigator

Lais Campos de Oliveira

doctoral student in Sciences Program Rehabilitation

Universidade Norte do Paraná

Eligibility Criteria

Inclusion Criteria

  • Clinical confirmation of postmenopausal for at least 12 months
  • Not exercise practitioner for at least six months
  • Agreement not to do another type of exercise during the search
  • Ability to perform activities of daily living without assistance
  • Medical certificate stating fitness to practice physical exercise; cognitive state ≥19 according to the Mini-Mental State Examination (MMSE)

Exclusion Criteria

  • Musculoskeletal disorders in the spine or the lower limbs in the last six months; fracture in the spine or lower limbs after 40 years of age
  • Prosthesis in the lower limbs or implants in the spine; Secondary causes of loss of bone mass
  • Other metabolic bone diseases or diseases affecting bone metabolism; history of cancer in the last five years; vascular changes
  • Epilepsy or seizures; arrhythmia; Pacemaker use; eye disease affecting the retina
  • Cardiorespiratory diseases; diseases in the neuromuscular system; labyrinthitis or lightheadedness
  • Hospitalization in the last six months for surgical reasons; alteration of Thyroid, drinking alcohol
  • Use of supplements such as calcium or vitamin D, or containing isoflavones
  • Medication to increase bone mineral density or increased muscle mass in the last 12 months
  • Inability to tolerate 5-minute whole body vibration

Outcomes

Primary Outcomes

Bone mineral density

Time Frame: six months

To analyze the bone mass of the femoral neck and lumbar spine (L1-L4) will use the device-ray Absorptiometry Dual Energy X (DXA) HOLOGIC, DQR-1000 PLUS model. The technique is based on the attenuation by the patient's body, a radiation beam generated by an X-ray source with two power levels, and exposure to radiation is lower than that of a conventional X-ray examination. The technique allows to estimate bone mass in whole and body segment. The results are transmitted to the computer that is connected to the device. Bone mineral density (BMD) is expressed as absolute values (g / cm2 grams of bone mineral content per area or analyzed bone cm2).

Secondary Outcomes

  • Flexibility(six months)
  • Muscle strength(six months)
  • Quality of life(six months)
  • The Timed Up and Go test (TUG)(six months)
  • Postural balance(six months)
  • Fear Falls(six months)

Study Sites (1)

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