Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

Study Overview
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Brief Summary
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To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.

Detailed Description
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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.

Official Title
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Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women

Conditions
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Fall Due to Loss of Equilibrium

Intervention / Treatment
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* Other: Pilates


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates group<br>This group receives physical training based on pilates exercises | Other: Pilates<br>* 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.<br>|
| No Intervention: No intervention group<br>This group does not receive any treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamometer | Dynamometer will be employed to assess hand grip stregth. | At the beginning and at three months | 
| ABC-16 (Activities Specific Balance Confidence Scale) | Questionnaire that assesses balance confidence in performing activities of daily living. | At the beginning and at three months | 
| FES-I (Falls Efficacy Scale-International) | Questionnaire that evaluates the fear of falling. | At the beginning and at three months | 
| Barthel index | Measures disability or dependence in activities of daily living | At the beginning and at three months | 
| KATZ INDEX | 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) | 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) | 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) | 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) | Used extensively for assessing health-related quality of life. | At the beginning and at three months | 
| MRS (Menopause Rating Scale): | 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) | Is a brief questionnaire that evaluates sexual functioning in women. | At the beginning and at three months | 
| INBODY | 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) | Is mineral mass in bone. | At the beginning and at three months | 
| Body Weight | Is the sum of Body Fat and Fat Free Mass. | At the beginning and at three months | 
| Skeletal Muscle Mass (kg) | 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 | At the beginning and at three months | 
| Lean Body Mass | The amount of lean body mass. | At the beginning and at three months | 
| Body Fat Mass | 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 (%) | Indicates the percentage of body fat to body weight. | At the beginning and at three months | 
| BMI (Body Mass Index) | 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 | 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 | 
| OPTOGAIT | 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 | At the beginning and at three months | 
| TUG (Timed Up and Go test) | Is a simple test used to assess a person's mobility and physical function | At the beginning and at three months | 
| CT10P | Test that evaluates the balance by walking along a straight line. | At the beginning and at three months | 
| STABILOMETRIC PLATFORM | 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 | 
| X mean | Mean value of the lateral oscillations of the Pressure Center | At the beginning and at three months | 
| Y mean | Mean value of the anteroposterior oscillations of the Pressure Center | At the beginning and at three months | 
| RMS X | Mean position of the center of pressure in the mediolateral plane. | At the beginning and at three months | 
| RMS Y | Mean position of the center of pressure in the anteroposterior plane | At the beginning and at three months | 
| Length | Length of the path described by the center of pressure. | At the beginning and at three months | 
| Area | Area of the path described by the center of pressure. | At the beginning and at three months | 
| Velocity | 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 | 
| Isaac test | Questionnaire that measures verbal fluency. | At the beginning and at three months | 
| trail making test part a y b | Neuropsychological test of visual attention and task switching. | At the beginning and at three months | 
| mmse (mini-mental state examination) | 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 | To test low back and hamstring flexibility. | At the beginning and at three months | 
| back scratch test | To measure general shoulder range of motion. | At the beginning and at three months | 
| 30-second chair stand test | To test leg strength and endurance. | At the beginning and at three months | 
| height | The distance between the lowest and highest points of a person standing upright. | At the beginning and at three months | 
| waist circumference | Is used to assess central fat distribution and degree of abdominal obesity. | At the beginning and at three months | 
| hip circumference | It is the greatest circumference of hip | At the beginning and at three months | 
| waist-to-hip ratio | 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 |