Bone Mineral Density Quantitative Trait Locus 3 Clinical Trial
Official title:
Effects of Whole Body Vibration and Pilates Method on Bone Mineral Density in Postmenopausal Women: a Randomized, Controlled, Clinical Trial
| Verified date | November 2017 |
| Source | Universidade Norte do Paraná |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | December 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Universidade Norte do Paraná | Londrina | Paraná |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Norte do Paraná |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Muscle strength | The muscle strength of the lower limbs will be measured through the movements of extension and knee flexion (concentric / concentric) with the Biodex System 4.0 equipment (Biodex Medical Systems, Shirley, NY), using to the extent the number less preferably with three tries, five repetitions each at an angular velocity of 60 and 180 degrees per second (60º / s and 180º / s). Among the attempts will be respected 30 seconds of rest. Will be considered for analysis, peak isokinetic torque (PT) and total work (TW), expressed in newtons per meter (Nm) and joules (J) respectively. Prior to the test, the device will be calibrated following the manufacturer's standards. The heating will be held for five minutes in an upright stationary bike with light load (25 watts) and comfortable speed (50 revolutions per minute). | six months | |
| Secondary | Flexibility | For analysis of the flexibility instrument will be used Fleximeter (Institute Code Research, São Paulo, Brazil), for the flexion and extension of the trunk. For the trunk flexion movement, the volunteer should remain standing, with extended knees, bent arms, hands resting on the neck. Fleximeter will be positioned laterally in the thoracic region, with the display facing the evaluator, the right side of the trunk. With voluntary upright, the evaluator should reset the Fleximeter and later support the hands on the knees of voluntary in order to preclude the bending thereof. Following the voluntary hold the maximum flexion of the trunk, holding this position for a few seconds so that the evaluator performs the reading range of motion. For the trunk extension movement, the procedures will be the same, however, voluntary hold the maximum extension of the trunk. | six months | |
| Secondary | Postural balance | For assessment of postural balance static will be used a force platform, BIOMEC 400 model (EMG System of Brazil Ltda., São Paulo). The assessor will explain the test procedures for voluntary, which will have a moment of familiarization with the equipment and the test will run. Following the participants carry out the balancing task with bipedal support, (with eyes open and eyes closed), semi-tandem (with eyes open and then with eyes closed) and one-leg (with eyes open). 30 seconds three attempts will be made with equal rest time (30 seconds) there between. The order of execution of each task (bipedal, single leg and semi-tandem) will be randomized. For further analysis of the data, the average of attempts is used. The volunteers should be barefoot, loose arms and relaxed beside the body and the following head positioned horizontally at ground level, being oriented to look at a fixed target (white paper circle with 3 cm in diameter) positioned in the wall at a distance of 2 meters | six months | |
| Secondary | The Timed Up and Go test (TUG) | Will be used for analysis of functional mobility and the risk of falls. marking will be placed on the floor measuring three meters from the front of a chair with arms. The volunteer will be oriented that when said the word "already" should get up from the chair, normally walk to the end marker, turn and walk back to the chair, sitting down again. The timer will be triggered to be said the word "already" and stopped at the time the volunteer sit in the chair. The shorter the time taken for completion of this course, the better the result of the test (less than 10 seconds is considered low risk for falls; between 10 and 20 seconds, medium risk of falls; above 20 seconds a high risk of falls). Three attempts will be performed and only the best will be considered. | six months | |
| Secondary | Fear Falls | The evaluation of the fear of falling will be held across the range Falls Efficacy Scale - International (FES-I) in your translated and adapted for the Brazilian population, consisting of 16 questions that identify concern about the possibility of falling in daily activities, outdoor activities and social participation, their total score ranges between 16 and 64 points, so that higher scores indicate greater concern about falling. It demonstrates good reliability and internal consistency with values similar to the original version, considered appropriate to assess the fear of falling in the population of elderly Brazilians. | six months | |
| Secondary | Quality of life | For the quality of life will be used the Brazilian version of the SF-36 questionnaire. This questionnaire consists of 11 questions and 36 items covering eight components (domains or dimensions), represented by functional capacity (ten items), physical (four items), pain (two items), general health (five items), vitality (four items), social functioning (two items), emotional aspects (three items) and mental health (five items). The individual receives a score in each domain, ranging from 0 to 100, 0 being the worst score and 100 the best. | six months |
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