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Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

9 september 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

107

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pilates groep
Deze groep krijgt fysieke training op basis van pilatesoefeningen
Ander: 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.
Geen tussenkomst: Geen interventiegroep
Deze groep krijgt geen behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Skeletspiermassa (kg)
Tijdsspanne: In het begin en na drie maanden
Wordt berekend op basis van de spiermassa van de ledematen, die bijna bestaat uit skeletspieren en ongeveer 70% van de totale skeletspieren van het lichaam beslaat
In het begin en na drie maanden
TUG (Timed Up and Go-test)
Tijdsspanne: In het begin en na drie maanden
Is een eenvoudige test die wordt gebruikt om de mobiliteit en fysieke functie van een persoon te beoordelen
In het begin en na drie maanden
X bedoel
Tijdsspanne: In het begin en na drie maanden
Gemiddelde waarde van de laterale oscillaties van het drukcentrum
In het begin en na drie maanden
Y bedoel
Tijdsspanne: In het begin en na drie maanden
Gemiddelde waarde van de anteroposterieure oscillaties van het drukcentrum
In het begin en na drie maanden
Dynamometer
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: At the beginning and at three months
Questionnaire that evaluates the fear of falling.
At the beginning and at three months
Barthel index
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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):
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: At the beginning and at three months
Is mineral mass in bone.
At the beginning and at three months
Body Weight
Tijdsspanne: 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
Tijdsspanne: At the beginning and at three months
The amount of lean body mass.
At the beginning and at three months
Body Fat Mass
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: At the beginning and at three months
To test low back and hamstring flexibility.
At the beginning and at three months
back scratch test
Tijdsspanne: 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
Tijdsspanne: At the beginning and at three months
To test leg strength and endurance.
At the beginning and at three months
height
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Jaén

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2017

Primaire voltooiing (Werkelijk)

1 november 2017

Studie voltooiing (Werkelijk)

27 februari 2018

Studieregistratiedata

Eerst ingediend

22 juni 2017

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2017

Eerst geplaatst (Werkelijk)

28 juni 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2021

Laatste update ingediend die voldeed aan QC-criteria

9 september 2021

Laatst geverifieerd

1 september 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UJaen

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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