Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
- Conditions
- Fall Due to Loss of Equilibrium
- Interventions
- Other: Pilates
- Registration Number
- NCT03201107
- Lead Sponsor
- University of Jaén
- Brief Summary
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 107
- 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.
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pilates group Pilates This group receives physical training based on pilates exercises
- Primary Outcome Measures
Name Time Method MRS (Menopause Rating Scale): 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) At the beginning and at three months Questionnaire that assesses balance confidence in performing activities of daily living.
Body Fat Mass 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 (%) At the beginning and at three months Indicates the percentage of body fat to body weight.
Velocity 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) At the beginning and at three months Questionnaire that evaluates the fear of falling.
FSS (Fatigue Severity Scale) 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 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) 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 At the beginning and at three months Mean position of the center of pressure in the mediolateral plane.
RMS Y At the beginning and at three months Mean position of the center of pressure in the anteroposterior plane
30-second chair stand test At the beginning and at three months To test leg strength and endurance.
height At the beginning and at three months The distance between the lowest and highest points of a person standing upright.
Dynamometer At the beginning and at three months Dynamometer will be employed to assess hand grip stregth.
Barthel index At the beginning and at three months Measures disability or dependence in activities of daily living
KATZ INDEX 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) 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) At the beginning and at three months Used extensively for assessing health-related quality of life.
STABILOMETRIC PLATFORM 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 At the beginning and at three months It is the greatest circumference of hip
HADS (The Hospital Anxiety And Depression) 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) At the beginning and at three months Is a brief questionnaire that evaluates sexual functioning in women.
Bone Mineral Content (BMC) At the beginning and at three months Is mineral mass in bone.
OPTOGAIT 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) At the beginning and at three months Is a simple test used to assess a person's mobility and physical function
Length At the beginning and at three months Length of the path described by the center of pressure.
Isaac test At the beginning and at three months Questionnaire that measures verbal fluency.
mmse (mini-mental state examination) At the beginning and at three months A tool that can be used to systematically and thoroughly assess mental status.
waist circumference At the beginning and at three months Is used to assess central fat distribution and degree of abdominal obesity.
waist-to-hip ratio 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 At the beginning and at three months Is the sum of Body Fat and Fat Free Mass.
Lean Body Mass At the beginning and at three months The amount of lean body mass.
BMI (Body Mass Index) 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 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 At the beginning and at three months Test that evaluates the balance by walking along a straight line.
X mean At the beginning and at three months Mean value of the lateral oscillations of the Pressure Center
Y mean At the beginning and at three months Mean value of the anteroposterior oscillations of the Pressure Center
Area At the beginning and at three months Area of the path described by the center of pressure.
trail making test part a y b At the beginning and at three months Neuropsychological test of visual attention and task switching.
chair sit and reach test At the beginning and at three months To test low back and hamstring flexibility.
back scratch test At the beginning and at three months To measure general shoulder range of motion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center of active participation of seniors of Jaén "Catedral"
🇪🇸Jaén, Spain