Effects of Whole Body Vibration and Pilates on Bone Mineral Density in Postmenopausal Women
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 7, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 6, 2017
November 1, 2017
6 months
May 7, 2016
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mineral density
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).
six months
Secondary Outcomes (6)
Muscle strength
six months
Flexibility
six months
Postural balance
six months
The Timed Up and Go test (TUG)
six months
Fear Falls
six months
- +1 more secondary outcomes
Study Arms (3)
Whole-Body Vibration Group (WBV)
EXPERIMENTALWill 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.
Pilates Group (PG)
EXPERIMENTALWill 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).
Control Group (CG)
NO INTERVENTIONThe 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.
Interventions
Will be performed six months of WBV exercises
Will be performed six months of Pilates exercises
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Norte do Paraná
Londrina, Paraná, 86041-140, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deise A de Almeida Pires-Oliveira, Doctor
Universidade Norte do Paraná
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctoral student in Sciences Program Rehabilitation
Study Record Dates
First Submitted
May 7, 2016
First Posted
May 11, 2016
Study Start
May 1, 2016
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
November 6, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share