Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
2021年9月9日 更新者：Agustín Aibar Almazán、University of Jaén
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
107
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jaén、西班牙、23002
- Center of active participation of seniors of Jaén "Catedral"
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：普拉提组
该组接受基于普拉提练习的体能训练
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Training based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. |
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无干预：无干预组
本组不接受任何治疗
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
骨骼肌质量 (kg)
大体时间：开始时和三个月时
|
以四肢肌肉量计算，几乎由骨骼肌组成，约占全身骨骼肌的70%
|
开始时和三个月时
|
|
TUG（定时启动测试）
大体时间：开始时和三个月时
|
是用于评估一个人的行动能力和身体机能的简单测试
|
开始时和三个月时
|
|
X均值
大体时间：开始时和三个月时
|
压力中心横向振荡的平均值
|
开始时和三个月时
|
|
Y均值
大体时间：开始时和三个月时
|
压力中心前后摆动的平均值
|
开始时和三个月时
|
|
Dynamometer
大体时间：At the beginning and at three months
|
Dynamometer will be employed to assess hand grip stregth.
|
At the beginning and at three months
|
|
ABC-16 (Activities Specific Balance Confidence Scale)
大体时间：At the beginning and at three months
|
Questionnaire that assesses balance confidence in performing activities of daily living.
|
At the beginning and at three months
|
|
FES-I (Falls Efficacy Scale-International)
大体时间：At the beginning and at three months
|
Questionnaire that evaluates the fear of falling.
|
At the beginning and at three months
|
|
Barthel index
大体时间：At the beginning and at three months
|
Measures disability or dependence in activities of daily living
|
At the beginning and at three months
|
|
KATZ INDEX
大体时间：At the beginning and at three months
|
Is a widely used tool to assess the level of independency in older adults.
|
At the beginning and at three months
|
|
FSS (Fatigue Severity Scale)
大体时间：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.
|
At the beginning and at three months
|
|
PSQI (Pittsburgh Sleep Quality Index)
大体时间：At the beginning and at three months
|
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
|
At the beginning and at three months
|
|
HADS (The Hospital Anxiety And Depression)
大体时间：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.
|
At the beginning and at three months
|
|
SF-36 (The Short Form-36 Health Survey)
大体时间：At the beginning and at three months
|
Used extensively for assessing health-related quality of life.
|
At the beginning and at three months
|
|
MRS (Menopause Rating Scale):
大体时间：At the beginning and at three months
|
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
|
At the beginning and at three months
|
|
FSFI (Female Sexual Function Index)
大体时间：At the beginning and at three months
|
Is a brief questionnaire that evaluates sexual functioning in women.
|
At the beginning and at three months
|
|
INBODY
大体时间：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.
|
At the beginning and at three months
|
|
Bone Mineral Content (BMC)
大体时间：At the beginning and at three months
|
Is mineral mass in bone.
|
At the beginning and at three months
|
|
Body Weight
大体时间：At the beginning and at three months
|
Is the sum of Body Fat and Fat Free Mass.
|
At the beginning and at three months
|
|
Lean Body Mass
大体时间：At the beginning and at three months
|
The amount of lean body mass.
|
At the beginning and at three months
|
|
Body Fat Mass
大体时间：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.
|
At the beginning and at three months
|
|
Percent of Body Fat (%)
大体时间：At the beginning and at three months
|
Indicates the percentage of body fat to body weight.
|
At the beginning and at three months
|
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BMI (Body Mass Index)
大体时间：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.
|
At the beginning and at three months
|
|
Segmental Analysis
大体时间：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.
|
At the beginning and at three months
|
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OPTOGAIT
大体时间：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
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At the beginning and at three months
|
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CT10P
大体时间：At the beginning and at three months
|
Test that evaluates the balance by walking along a straight line.
|
At the beginning and at three months
|
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STABILOMETRIC PLATFORM
大体时间：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.
|
At the beginning and at three months
|
|
RMS X
大体时间：At the beginning and at three months
|
Mean position of the center of pressure in the mediolateral plane.
|
At the beginning and at three months
|
|
RMS Y
大体时间：At the beginning and at three months
|
Mean position of the center of pressure in the anteroposterior plane
|
At the beginning and at three months
|
|
Length
大体时间：At the beginning and at three months
|
Length of the path described by the center of pressure.
|
At the beginning and at three months
|
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Area
大体时间：At the beginning and at three months
|
Area of the path described by the center of pressure.
|
At the beginning and at three months
|
|
Velocity
大体时间：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.
|
At the beginning and at three months
|
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Isaac test
大体时间：At the beginning and at three months
|
Questionnaire that measures verbal fluency.
|
At the beginning and at three months
|
|
trail making test part a y b
大体时间：At the beginning and at three months
|
Neuropsychological test of visual attention and task switching.
|
At the beginning and at three months
|
|
mmse (mini-mental state examination)
大体时间：At the beginning and at three months
|
A tool that can be used to systematically and thoroughly assess mental status.
|
At the beginning and at three months
|
|
chair sit and reach test
大体时间：At the beginning and at three months
|
To test low back and hamstring flexibility.
|
At the beginning and at three months
|
|
back scratch test
大体时间：At the beginning and at three months
|
To measure general shoulder range of motion.
|
At the beginning and at three months
|
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30-second chair stand test
大体时间：At the beginning and at three months
|
To test leg strength and endurance.
|
At the beginning and at three months
|
|
height
大体时间：At the beginning and at three months
|
The distance between the lowest and highest points of a person standing upright.
|
At the beginning and at three months
|
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waist circumference
大体时间：At the beginning and at three months
|
Is used to assess central fat distribution and degree of abdominal obesity.
|
At the beginning and at three months
|
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hip circumference
大体时间：At the beginning and at three months
|
It is the greatest circumference of hip
|
At the beginning and at three months
|
|
waist-to-hip ratio
大体时间：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.
|
At the beginning and at three months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月1日
初级完成 (实际的)
2017年11月1日
研究完成 (实际的)
2018年2月27日
研究注册日期
首次提交
2017年6月22日
首先提交符合 QC 标准的
2017年6月23日
首次发布 (实际的)
2017年6月28日
研究记录更新
最后更新发布 (实际的)
2021年9月16日
上次提交的符合 QC 标准的更新
2021年9月9日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.