Fall Due to Loss of Equilibrium
Conditions
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.
Interventions
OTHERPilates
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.
Sponsors
University of Jaén
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length | At the beginning and at three months | Length of the path described by the center of pressure. |
| Area | At the beginning and at three months | Area of the path described by the center of pressure. |
| 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. |
| Isaac test | At the beginning and at three months | Questionnaire that measures verbal fluency. |
| trail making test part a y b | At the beginning and at three months | Neuropsychological test of visual attention and task switching. |
| 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. |
| 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. |
| 30-second chair stand test | At the beginning and at three months | To test leg strength and endurance. |
| Dynamometer | At the beginning and at three months | Dynamometer will be employed to assess hand grip stregth. |
| 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. |
| FES-I (Falls Efficacy Scale-International) | At the beginning and at three months | Questionnaire that evaluates the fear of falling. |
| 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. |
| 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. |
| 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. |
| height | At the beginning and at three months | The distance between the lowest and highest points of a person standing upright. |
| waist circumference | At the beginning and at three months | Is used to assess central fat distribution and degree of abdominal obesity. |
| hip circumference | At the beginning and at three months | It is the greatest circumference of hip |
| 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. |
| 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. |
| SF-36 (The Short Form-36 Health Survey) | At the beginning and at three months | Used extensively for assessing health-related quality of life. |
| 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. |
| FSFI (Female Sexual Function Index) | At the beginning and at three months | Is a brief questionnaire that evaluates sexual functioning in women. |
| 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. |
| Bone Mineral Content (BMC) | At the beginning and at three months | Is mineral mass in bone. |
| Body Weight | At the beginning and at three months | Is the sum of Body Fat and Fat Free Mass. |
| 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 |
| Lean Body Mass | At the beginning and at three months | The amount of lean body mass. |
| 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. |
| 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. |
| 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 |
| CT10P | At the beginning and at three months | Test that evaluates the balance by walking along a straight line. |
| 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. |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed