Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

September 9, 2021 updated by: Agustín Aibar Almazán, University of Jaén

Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaén, Spain, 23002
        • Center of active participation of seniors of Jaén "Catedral"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates group
This group receives physical training based on pilates exercises
Other: Pilates

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.
No Intervention: No intervention group
This group does not receive any treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the beginning and at three months
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
At the beginning and at three months
X mean
Time Frame: At the beginning and at three months
Mean value of the lateral oscillations of the Pressure Center
At the beginning and at three months
Y mean
Time Frame: At the beginning and at three months
Mean value of the anteroposterior oscillations of the Pressure Center
At the beginning and at three months
Dynamometer
Time Frame: At the beginning and at three months
Dynamometer will be employed to assess hand grip stregth.
At the beginning and at three months
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.
At the beginning and at three months
FES-I (Falls Efficacy Scale-International)
Time Frame: At the beginning and at three months
Questionnaire that evaluates the fear of falling.
At the beginning and at three months
Barthel index
Time Frame: At the beginning and at three months
Measures disability or dependence in activities of daily living
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
FSFI (Female Sexual Function Index)
Time Frame: At the beginning and at three months
Is a brief questionnaire that evaluates sexual functioning in women.
At the beginning and at three months
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.
At the beginning and at three months
Bone Mineral Content (BMC)
Time Frame: At the beginning and at three months
Is mineral mass in bone.
At the beginning and at three months
Body Weight
Time Frame: At the beginning and at three months
Is the sum of Body Fat and Fat Free Mass.
At the beginning and at three months
Lean Body Mass
Time Frame: At the beginning and at three months
The amount of lean body mass.
At the beginning and at three months
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.
At the beginning and at three months
Percent of Body Fat (%)
Time Frame: At the beginning and at three months
Indicates the percentage of body fat to body weight.
At the beginning and at three months
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.
At the beginning and at three months
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.
At the beginning and at three months
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
At the beginning and at three months
CT10P
Time Frame: At the beginning and at three months
Test that evaluates the balance by walking along a straight line.
At the beginning and at three months
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.
At the beginning and at three months
RMS X
Time Frame: At the beginning and at three months
Mean position of the center of pressure in the mediolateral plane.
At the beginning and at three months
RMS Y
Time Frame: At the beginning and at three months
Mean position of the center of pressure in the anteroposterior plane
At the beginning and at three months
Length
Time Frame: At the beginning and at three months
Length of the path described by the center of pressure.
At the beginning and at three months
Area
Time Frame: At the beginning and at three months
Area of the path described by the center of pressure.
At the beginning and at three months
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.
At the beginning and at three months
Isaac test
Time Frame: At the beginning and at three months
Questionnaire that measures verbal fluency.
At the beginning and at three months
trail making test part a y b
Time Frame: At the beginning and at three months
Neuropsychological test of visual attention and task switching.
At the beginning and at three months
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.
At the beginning and at three months
chair sit and reach test
Time Frame: At the beginning and at three months
To test low back and hamstring flexibility.
At the beginning and at three months
back scratch test
Time Frame: At the beginning and at three months
To measure general shoulder range of motion.
At the beginning and at three months
30-second chair stand test
Time Frame: At the beginning and at three months
To test leg strength and endurance.
At the beginning and at three months
height
Time Frame: At the beginning and at three months
The distance between the lowest and highest points of a person standing upright.
At the beginning and at three months
waist circumference
Time Frame: At the beginning and at three months
Is used to assess central fat distribution and degree of abdominal obesity.
At the beginning and at three months
hip circumference
Time Frame: At the beginning and at three months
It is the greatest circumference of hip
At the beginning and at three months
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.
At the beginning and at three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jaén

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UJaen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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