Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

NCT03201107 | Completed

• 1 other identifier: UJaen
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fall Due to Loss of Equilibrium

Outcome Measures

Primary Outcomes (41)

• 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

Study Arms (2)

Pilates group

EXPERIMENTAL

This group receives physical training based on pilates exercises

Other: Pilates

No intervention group

NO INTERVENTION

This group does not receive any treatment

Interventions

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.

Pilates group

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindications for conducting physical tests.
• Diseases that limit the static and dynamic balance and physical activity. -
• Central or peripheral vestibular or nerve alterations.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Center of active participation of seniors of Jaén "Catedral"

Jaén, 23002, Spain

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 28, 2017
• Study Start: August 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: February 27, 2018
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)