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Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

Primary Purpose

Fall Due to Loss of Equilibrium

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pilates
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fall Due to Loss of Equilibrium

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Center of active participation of seniors of Jaén "Catedral"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pilates group

No intervention group

Arm Description

This group receives physical training based on pilates exercises

This group does not receive any treatment

Outcomes

Primary Outcome Measures

Dynamometer
Dynamometer will be employed to assess hand grip stregth.
ABC-16 (Activities Specific Balance Confidence Scale)
Questionnaire that assesses balance confidence in performing activities of daily living.
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling.
Barthel index
Measures disability or dependence in activities of daily living
KATZ INDEX
Is a widely used tool to assess the level of independency in older adults.
FSS (Fatigue Severity Scale)
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
HADS (The Hospital Anxiety And Depression)
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)
Used extensively for assessing health-related quality of life.
MRS (Menopause Rating Scale):
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
FSFI (Female Sexual Function Index)
Is a brief questionnaire that evaluates sexual functioning in women.
INBODY
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
Bone Mineral Content (BMC)
Is mineral mass in bone.
Body Weight
Is the sum of Body Fat and Fat Free Mass.
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
Lean Body Mass
The amount of lean body mass.
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.
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight.
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.
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.
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
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function
CT10P
Test that evaluates the balance by walking along a straight line.
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.
X mean
Mean value of the lateral oscillations of the Pressure Center
Y mean
Mean value of the anteroposterior oscillations of the Pressure Center
RMS X
Mean position of the center of pressure in the mediolateral plane.
RMS Y
Mean position of the center of pressure in the anteroposterior plane
Length
Length of the path described by the center of pressure.
Area
Area of the path described by the center of pressure.
Velocity
Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
Isaac test
Questionnaire that measures verbal fluency.
trail making test part a y b
Neuropsychological test of visual attention and task switching.
mmse (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
chair sit and reach test
To test low back and hamstring flexibility.
back scratch test
To measure general shoulder range of motion.
30-second chair stand test
To test leg strength and endurance.
height
The distance between the lowest and highest points of a person standing upright.
waist circumference
Is used to assess central fat distribution and degree of abdominal obesity.
hip circumference
It is the greatest circumference of hip
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
September 9, 2021
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT03201107
Brief Title
Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
Official Title
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall Due to Loss of Equilibrium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates group
Arm Type
Experimental
Arm Description
This group receives physical training based on pilates exercises
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
This group does not receive any treatment
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
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 Outcome Measure Information:
Title
Dynamometer
Description
Dynamometer will be employed to assess hand grip stregth.
Time Frame
At the beginning and at three months
Title
ABC-16 (Activities Specific Balance Confidence Scale)
Description
Questionnaire that assesses balance confidence in performing activities of daily living.
Time Frame
At the beginning and at three months
Title
FES-I (Falls Efficacy Scale-International)
Description
Questionnaire that evaluates the fear of falling.
Time Frame
At the beginning and at three months
Title
Barthel index
Description
Measures disability or dependence in activities of daily living
Time Frame
At the beginning and at three months
Title
KATZ INDEX
Description
Is a widely used tool to assess the level of independency in older adults.
Time Frame
At the beginning and at three months
Title
FSS (Fatigue Severity Scale)
Description
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
Time Frame
At the beginning and at three months
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
Time Frame
At the beginning and at three months
Title
HADS (The Hospital Anxiety And Depression)
Description
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
Time Frame
At the beginning and at three months
Title
SF-36 (The Short Form-36 Health Survey)
Description
Used extensively for assessing health-related quality of life.
Time Frame
At the beginning and at three months
Title
MRS (Menopause Rating Scale):
Description
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
Time Frame
At the beginning and at three months
Title
FSFI (Female Sexual Function Index)
Description
Is a brief questionnaire that evaluates sexual functioning in women.
Time Frame
At the beginning and at three months
Title
INBODY
Description
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
Time Frame
At the beginning and at three months
Title
Bone Mineral Content (BMC)
Description
Is mineral mass in bone.
Time Frame
At the beginning and at three months
Title
Body Weight
Description
Is the sum of Body Fat and Fat Free Mass.
Time Frame
At the beginning and at three months
Title
Skeletal Muscle Mass (kg)
Description
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
Time Frame
At the beginning and at three months
Title
Lean Body Mass
Description
The amount of lean body mass.
Time Frame
At the beginning and at three months
Title
Body Fat Mass
Description
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.
Time Frame
At the beginning and at three months
Title
Percent of Body Fat (%)
Description
Indicates the percentage of body fat to body weight.
Time Frame
At the beginning and at three months
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Time Frame
At the beginning and at three months
Title
Segmental Analysis
Description
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.
Time Frame
At the beginning and at three months
Title
OPTOGAIT
Description
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
Time Frame
At the beginning and at three months
Title
TUG (Timed Up and Go test)
Description
Is a simple test used to assess a person's mobility and physical function
Time Frame
At the beginning and at three months
Title
CT10P
Description
Test that evaluates the balance by walking along a straight line.
Time Frame
At the beginning and at three months
Title
STABILOMETRIC PLATFORM
Description
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.
Time Frame
At the beginning and at three months
Title
X mean
Description
Mean value of the lateral oscillations of the Pressure Center
Time Frame
At the beginning and at three months
Title
Y mean
Description
Mean value of the anteroposterior oscillations of the Pressure Center
Time Frame
At the beginning and at three months
Title
RMS X
Description
Mean position of the center of pressure in the mediolateral plane.
Time Frame
At the beginning and at three months
Title
RMS Y
Description
Mean position of the center of pressure in the anteroposterior plane
Time Frame
At the beginning and at three months
Title
Length
Description
Length of the path described by the center of pressure.
Time Frame
At the beginning and at three months
Title
Area
Description
Area of the path described by the center of pressure.
Time Frame
At the beginning and at three months
Title
Velocity
Description
Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
Time Frame
At the beginning and at three months
Title
Isaac test
Description
Questionnaire that measures verbal fluency.
Time Frame
At the beginning and at three months
Title
trail making test part a y b
Description
Neuropsychological test of visual attention and task switching.
Time Frame
At the beginning and at three months
Title
mmse (mini-mental state examination)
Description
A tool that can be used to systematically and thoroughly assess mental status.
Time Frame
At the beginning and at three months
Title
chair sit and reach test
Description
To test low back and hamstring flexibility.
Time Frame
At the beginning and at three months
Title
back scratch test
Description
To measure general shoulder range of motion.
Time Frame
At the beginning and at three months
Title
30-second chair stand test
Description
To test leg strength and endurance.
Time Frame
At the beginning and at three months
Title
height
Description
The distance between the lowest and highest points of a person standing upright.
Time Frame
At the beginning and at three months
Title
waist circumference
Description
Is used to assess central fat distribution and degree of abdominal obesity.
Time Frame
At the beginning and at three months
Title
hip circumference
Description
It is the greatest circumference of hip
Time Frame
At the beginning and at three months
Title
waist-to-hip ratio
Description
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.
Time Frame
At the beginning and at three months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Center of active participation of seniors of Jaén "Catedral"
City
Jaén
ZIP/Postal Code
23002
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

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