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Completed

NCT Number: NCT03201107

Obesity, Sarcopenic, Risk of Falls 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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center of active participation of seniors of Jaén "Catedral"

Jaén, 23002, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates

Other

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.

Primary outcomes

  1. Dynamometer

    Time frame: At the beginning and at three months

    Dynamometer will be employed to assess hand grip stregth.

  2. ABC-16 (Activities Specific Balance Confidence Scale)

    Time frame: At the beginning and at three months

    Questionnaire that assesses balance confidence in performing activities of daily living.

  3. FES-I (Falls Efficacy Scale-International)

    Time frame: At the beginning and at three months

    Questionnaire that evaluates the fear of falling.

  4. Barthel index

    Time frame: At the beginning and at three months

    Measures disability or dependence in activities of daily living

  5. KATZ INDEX

    Time frame: At the beginning and at three months

    Is a widely used tool to assess the level of independency in older adults.

  6. FSS (Fatigue Severity Scale)

    Time frame: 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.

  7. PSQI (Pittsburgh Sleep Quality Index)

    Time frame: At the beginning and at three months

    A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.

  8. HADS (The Hospital Anxiety And Depression)

    Time frame: 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.

  9. SF-36 (The Short Form-36 Health Survey)

    Time frame: At the beginning and at three months

    Used extensively for assessing health-related quality of life.

  10. MRS (Menopause Rating Scale):

    Time frame: At the beginning and at three months

    Assesses the severity of menopause-related complaints and the impact on health-related quality of life.

  11. FSFI (Female Sexual Function Index)

    Time frame: At the beginning and at three months

    Is a brief questionnaire that evaluates sexual functioning in women.

  12. INBODY

    Time frame: 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.

  13. Bone Mineral Content (BMC)

    Time frame: At the beginning and at three months

    Is mineral mass in bone.

  14. Body Weight

    Time frame: At the beginning and at three months

    Is the sum of Body Fat and Fat Free Mass.

  15. Skeletal Muscle Mass (kg)

    Time frame: 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

  16. Lean Body Mass

    Time frame: At the beginning and at three months

    The amount of lean body mass.

  17. Body Fat Mass

    Time frame: 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.

  18. Percent of Body Fat (%)

    Time frame: At the beginning and at three months

    Indicates the percentage of body fat to body weight.

  19. BMI (Body Mass Index)

    Time frame: 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.

  20. Segmental Analysis

    Time frame: 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.

  21. OPTOGAIT

    Time frame: 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

  22. TUG (Timed Up and Go test)

    Time frame: At the beginning and at three months

    Is a simple test used to assess a person's mobility and physical function

  23. CT10P

    Time frame: At the beginning and at three months

    Test that evaluates the balance by walking along a straight line.

  24. STABILOMETRIC PLATFORM

    Time frame: 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.

  25. X mean

    Time frame: At the beginning and at three months

    Mean value of the lateral oscillations of the Pressure Center

  26. Y mean

    Time frame: At the beginning and at three months

    Mean value of the anteroposterior oscillations of the Pressure Center

  27. RMS X

    Time frame: At the beginning and at three months

    Mean position of the center of pressure in the mediolateral plane.

  28. RMS Y

    Time frame: At the beginning and at three months

    Mean position of the center of pressure in the anteroposterior plane

  29. Length

    Time frame: At the beginning and at three months

    Length of the path described by the center of pressure.

  30. Area

    Time frame: At the beginning and at three months

    Area of the path described by the center of pressure.

  31. Velocity

    Time frame: 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.

  32. Isaac test

    Time frame: At the beginning and at three months

    Questionnaire that measures verbal fluency.

  33. trail making test part a y b

    Time frame: At the beginning and at three months

    Neuropsychological test of visual attention and task switching.

  34. mmse (mini-mental state examination)

    Time frame: At the beginning and at three months

    A tool that can be used to systematically and thoroughly assess mental status.

  35. chair sit and reach test

    Time frame: At the beginning and at three months

    To test low back and hamstring flexibility.

  36. back scratch test

    Time frame: At the beginning and at three months

    To measure general shoulder range of motion.

  37. 30-second chair stand test

    Time frame: At the beginning and at three months

    To test leg strength and endurance.

  38. height

    Time frame: At the beginning and at three months

    The distance between the lowest and highest points of a person standing upright.

  39. waist circumference

    Time frame: At the beginning and at three months

    Is used to assess central fat distribution and degree of abdominal obesity.

  40. hip circumference

    Time frame: At the beginning and at three months

    It is the greatest circumference of hip

  41. waist-to-hip ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 28, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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