Overview

This trial is active, not recruiting.

Condition bone mineral density quantitative trait locus 3
Treatments whole-body vibration, pilates
Phase phase 0
Sponsor Universidade Norte do Paraná
Start date May 2016
End date May 2016
Trial size 51 participants
Trial identifier NCT02769143, 1.032.182

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Will be exposed to five minutes on a vibrating platform (Oscillating Platform Semi-Professional Horizontal - Arktus, Cascavel, Brazil), this type of platform vibrates through an anteroposterior axis, causing the right and left sides alternate horizontally denominated: alternating side vibration platforms, will be performed three times per week on alternate days (5 minutes). a frequency of 20 Hz (1 = 1 Hz oscillation / second) and a magnitude of 3.2 g (1 g = 9,81 m / s gravity) is used. The volunteers will be guided to stand on the platform with semi-flexed knees, barefoot and apart about hip width.
whole-body vibration Whole-Body Vibration Exercise
Will be performed six months of WBV exercises
(Experimental)
Will be exposed to 60 minutes, held three times a week on alternate days. Pilates equipment used for the exercises are: Combo Chair, Cadillac Trapeze, Ladder Barrel, Reformer Universal, Step Barrel and Wall Unit. Will be selected for this study, 21 strengthening exercises and stretching to the main body segments. All exercises are performed in a series of ten repetitions with one minute interval between exercises. To determine the level of effort and consequently to changing loads, will be used verbal command according to the Borg CR10 scale. The level of effort will be maintained during the session heavy (Borg between 5 and 6).
pilates Pilates Exercise
Will be performed six months of Pilates exercises
(No Intervention)
The control group will be instructed to maintain their usual activities both in relation to their daily activities, dietary habits, failure to use drugs that can influence the increase in bone mass and participate in monthly meetings to address on issues osteoporosis and postmenopausal women. After the end of the interventions with WBV and GP groups, GC volunteers will be invited to also perform whole body vibration for six months. Exposure of vibration will be for five minutes on a vibrating platform, three times per week on alternate days. a frequency of 20 Hz (1 = 1 Hz oscillation / second) and a magnitude of 3.2 g (1 g = 9,81 m / s gravity) is used. Likewise which was offered for the WBV group.

Primary Outcomes

Measure
Bone mineral density
time frame: six months

Secondary Outcomes

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

Eligibility Criteria

Female participants from 40 years up to 75 years old.

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

Additional Information

Official title Effects of Whole Body Vibration and Pilates Method on Bone Mineral Density in Postmenopausal Women: a Randomized, Controlled, Clinical Trial
Principal investigator Deise A de Almeida Pires-Oliveira, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Universidade Norte do Paraná.