Clinical trial NCT02769143: Effects of Whole Body Vibration and Pilates on Bone Mineral Density in Postmenopausal Women
Official title: Effects of Whole Body Vibration and Pilates Method on Bone Mineral Density in Postmenopausal Women: a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Mineral Density Quantitative Trait Locus 3
Keywords: Postmenopausal
Bone Density
Exercise
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 51
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Smoking
* 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

Primary outcomes:
measure: Bone mineral density
timeFrame: six months
Secondary outcomes:
measure: Muscle strength
timeFrame: six months
measure: Flexibility
timeFrame: six months
measure: Postural balance
timeFrame: six months
measure: The Timed Up and Go test (TUG)
timeFrame: six months
measure: Fear Falls
timeFrame: six months
measure: Quality of life
timeFrame: six months
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Norte do Paraná
state: Paraná
Study officials:
affiliation: Universidade Norte do Paraná
name: Deise A de Almeida Pires-Oliveira, Doctor
role: PRINCIPAL_INVESTIGATOR
References: