Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

Fall Due to Loss of Equilibrium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201107
• Other study ID #: UJaen
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: September 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 27, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall Due to Loss of Equilibrium
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Spain	Center of active participation of seniors of Jaén "Catedral"	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamometer	Dynamometer will be employed to assess hand grip stregth.	At the beginning and at three months
Primary	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
Primary	FES-I (Falls Efficacy Scale-International)	Questionnaire that evaluates the fear of falling.	At the beginning and at three months
Primary	Barthel index	Measures disability or dependence in activities of daily living	At the beginning and at three months
Primary	KATZ INDEX	Is a widely used tool to assess the level of independency in older adults.	At the beginning and at three months
Primary	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
Primary	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
Primary	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
Primary	SF-36 (The Short Form-36 Health Survey)	Used extensively for assessing health-related quality of life.	At the beginning and at three months
Primary	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
Primary	FSFI (Female Sexual Function Index)	Is a brief questionnaire that evaluates sexual functioning in women.	At the beginning and at three months
Primary	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
Primary	Bone Mineral Content (BMC)	Is mineral mass in bone.	At the beginning and at three months
Primary	Body Weight	Is the sum of Body Fat and Fat Free Mass.	At the beginning and at three months
Primary	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
Primary	Lean Body Mass	The amount of lean body mass.	At the beginning and at three months
Primary	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
Primary	Percent of Body Fat (%)	Indicates the percentage of body fat to body weight.	At the beginning and at three months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	CT10P	Test that evaluates the balance by walking along a straight line.	At the beginning and at three months
Primary	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
Primary	X mean	Mean value of the lateral oscillations of the Pressure Center	At the beginning and at three months
Primary	Y mean	Mean value of the anteroposterior oscillations of the Pressure Center	At the beginning and at three months
Primary	RMS X	Mean position of the center of pressure in the mediolateral plane.	At the beginning and at three months
Primary	RMS Y	Mean position of the center of pressure in the anteroposterior plane	At the beginning and at three months
Primary	Length	Length of the path described by the center of pressure.	At the beginning and at three months
Primary	Area	Area of the path described by the center of pressure.	At the beginning and at three months
Primary	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
Primary	Isaac test	Questionnaire that measures verbal fluency.	At the beginning and at three months
Primary	trail making test part a y b	Neuropsychological test of visual attention and task switching.	At the beginning and at three months
Primary	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
Primary	chair sit and reach test	To test low back and hamstring flexibility.	At the beginning and at three months
Primary	back scratch test	To measure general shoulder range of motion.	At the beginning and at three months
Primary	30-second chair stand test	To test leg strength and endurance.	At the beginning and at three months
Primary	height	The distance between the lowest and highest points of a person standing upright.	At the beginning and at three months
Primary	waist circumference	Is used to assess central fat distribution and degree of abdominal obesity.	At the beginning and at three months
Primary	hip circumference	It is the greatest circumference of hip	At the beginning and at three months
Primary	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