Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- MRS (Menopause Rating Scale):
研究概览
简要总结
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
详细描述
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.
All measurements given above will be made both to the control group and to the experimental group just prior to the start of the intervention, and immediately after and six months after the end of this period, and the results will be recorded in a data record
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No menstrual activity for at least 12 months.
- •Present obesity and / or sarcopenic.
- •Do not participate in a weight loss program.
- •Be able to understand the instructions, programs and protocols of this project.
排除标准
- •Contraindications for conducting physical tests.
- •Diseases that limit the static and dynamic balance and physical activity. -
- •Central or peripheral vestibular or nerve alterations.
结局指标
主要结局
MRS (Menopause Rating Scale):
时间窗: At the beginning and at three months
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
ABC-16 (Activities Specific Balance Confidence Scale)
时间窗: At the beginning and at three months
Questionnaire that assesses balance confidence in performing activities of daily living.
Body Fat Mass
时间窗: At the beginning and at three months
The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass.
Percent of Body Fat (%)
时间窗: At the beginning and at three months
Indicates the percentage of body fat to body weight.
Velocity
时间窗: At the beginning and at three months
Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
FES-I (Falls Efficacy Scale-International)
时间窗: At the beginning and at three months
Questionnaire that evaluates the fear of falling.
FSS (Fatigue Severity Scale)
时间窗: At the beginning and at three months
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
INBODY
时间窗: At the beginning and at three months
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
Skeletal Muscle Mass (kg)
时间窗: At the beginning and at three months
Is computed based on muscle mass of the limbs, which is almost composed of skeletal muscle and takes up about 70% of total body skeletal muscle
RMS X
时间窗: At the beginning and at three months
Mean position of the center of pressure in the mediolateral plane.
RMS Y
时间窗: At the beginning and at three months
Mean position of the center of pressure in the anteroposterior plane
30-second chair stand test
时间窗: At the beginning and at three months
To test leg strength and endurance.
height
时间窗: At the beginning and at three months
The distance between the lowest and highest points of a person standing upright.
Dynamometer
时间窗: At the beginning and at three months
Dynamometer will be employed to assess hand grip stregth.
Barthel index
时间窗: At the beginning and at three months
Measures disability or dependence in activities of daily living
KATZ INDEX
时间窗: At the beginning and at three months
Is a widely used tool to assess the level of independency in older adults.
PSQI (Pittsburgh Sleep Quality Index)
时间窗: At the beginning and at three months
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
SF-36 (The Short Form-36 Health Survey)
时间窗: At the beginning and at three months
Used extensively for assessing health-related quality of life.
STABILOMETRIC PLATFORM
时间窗: At the beginning and at three months
Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
hip circumference
时间窗: At the beginning and at three months
It is the greatest circumference of hip
HADS (The Hospital Anxiety And Depression)
时间窗: At the beginning and at three months
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
FSFI (Female Sexual Function Index)
时间窗: At the beginning and at three months
Is a brief questionnaire that evaluates sexual functioning in women.
Bone Mineral Content (BMC)
时间窗: At the beginning and at three months
Is mineral mass in bone.
OPTOGAIT
时间窗: At the beginning and at three months
Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions. REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement. It can be used to measure simple reactions or more complex movements
TUG (Timed Up and Go test)
时间窗: At the beginning and at three months
Is a simple test used to assess a person's mobility and physical function
Length
时间窗: At the beginning and at three months
Length of the path described by the center of pressure.
Isaac test
时间窗: At the beginning and at three months
Questionnaire that measures verbal fluency.
mmse (mini-mental state examination)
时间窗: At the beginning and at three months
A tool that can be used to systematically and thoroughly assess mental status.
waist circumference
时间窗: At the beginning and at three months
Is used to assess central fat distribution and degree of abdominal obesity.
waist-to-hip ratio
时间窗: At the beginning and at three months
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement.
Body Weight
时间窗: At the beginning and at three months
Is the sum of Body Fat and Fat Free Mass.
Lean Body Mass
时间窗: At the beginning and at three months
The amount of lean body mass.
BMI (Body Mass Index)
时间窗: At the beginning and at three months
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Segmental Analysis
时间窗: At the beginning and at three months
Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately. Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass.
CT10P
时间窗: At the beginning and at three months
Test that evaluates the balance by walking along a straight line.
X mean
时间窗: At the beginning and at three months
Mean value of the lateral oscillations of the Pressure Center
Y mean
时间窗: At the beginning and at three months
Mean value of the anteroposterior oscillations of the Pressure Center
Area
时间窗: At the beginning and at three months
Area of the path described by the center of pressure.
trail making test part a y b
时间窗: At the beginning and at three months
Neuropsychological test of visual attention and task switching.
chair sit and reach test
时间窗: At the beginning and at three months
To test low back and hamstring flexibility.
back scratch test
时间窗: At the beginning and at three months
To measure general shoulder range of motion.
次要结局
未报告次要终点
研究者
Agustín Aibar Almazán
Physiotherapy
University of Jaén