Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
9 septembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
107
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Jaén, Espagne, 23002
- Center of active participation of seniors of Jaén "Catedral"
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe Pilates
Ce groupe reçoit un entraînement physique basé sur des exercices de pilates
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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. |
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Aucune intervention: Pas de groupe d'intervention
Ce groupe ne reçoit aucun traitement
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Masse musculaire squelettique (kg)
Délai: Au début et à trois mois
|
Est calculé sur la base de la masse musculaire des membres, qui est presque composée de muscles squelettiques et occupe environ 70% du muscle squelettique total du corps
|
Au début et à trois mois
|
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TUG (test Timed Up and Go)
Délai: Au début et à trois mois
|
Est un test simple utilisé pour évaluer la mobilité et la fonction physique d'une personne
|
Au début et à trois mois
|
|
X signifie
Délai: Au début et à trois mois
|
Valeur moyenne des oscillations latérales du centre de pression
|
Au début et à trois mois
|
|
Y signifie
Délai: Au début et à trois mois
|
Valeur moyenne des oscillations antéropostérieures du Centre de Pression
|
Au début et à trois mois
|
|
Dynamometer
Délai: 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)
Délai: 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)
Délai: At the beginning and at three months
|
Questionnaire that evaluates the fear of falling.
|
At the beginning and at three months
|
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Barthel index
Délai: At the beginning and at three months
|
Measures disability or dependence in activities of daily living
|
At the beginning and at three months
|
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KATZ INDEX
Délai: 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)
Délai: 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)
Délai: 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
|
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HADS (The Hospital Anxiety And Depression)
Délai: 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
|
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SF-36 (The Short Form-36 Health Survey)
Délai: At the beginning and at three months
|
Used extensively for assessing health-related quality of life.
|
At the beginning and at three months
|
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MRS (Menopause Rating Scale):
Délai: 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)
Délai: At the beginning and at three months
|
Is a brief questionnaire that evaluates sexual functioning in women.
|
At the beginning and at three months
|
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INBODY
Délai: 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
|
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Bone Mineral Content (BMC)
Délai: At the beginning and at three months
|
Is mineral mass in bone.
|
At the beginning and at three months
|
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Body Weight
Délai: At the beginning and at three months
|
Is the sum of Body Fat and Fat Free Mass.
|
At the beginning and at three months
|
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Lean Body Mass
Délai: At the beginning and at three months
|
The amount of lean body mass.
|
At the beginning and at three months
|
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Body Fat Mass
Délai: 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
|
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Percent of Body Fat (%)
Délai: At the beginning and at three months
|
Indicates the percentage of body fat to body weight.
|
At the beginning and at three months
|
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BMI (Body Mass Index)
Délai: 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
|
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Segmental Analysis
Délai: 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
|
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OPTOGAIT
Délai: 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
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At the beginning and at three months
|
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CT10P
Délai: 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
|
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STABILOMETRIC PLATFORM
Délai: 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
|
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RMS X
Délai: 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
|
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RMS Y
Délai: 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
|
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Length
Délai: At the beginning and at three months
|
Length of the path described by the center of pressure.
|
At the beginning and at three months
|
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Area
Délai: At the beginning and at three months
|
Area of the path described by the center of pressure.
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At the beginning and at three months
|
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Velocity
Délai: 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
|
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Isaac test
Délai: At the beginning and at three months
|
Questionnaire that measures verbal fluency.
|
At the beginning and at three months
|
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trail making test part a y b
Délai: At the beginning and at three months
|
Neuropsychological test of visual attention and task switching.
|
At the beginning and at three months
|
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mmse (mini-mental state examination)
Délai: 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
|
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chair sit and reach test
Délai: At the beginning and at three months
|
To test low back and hamstring flexibility.
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At the beginning and at three months
|
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back scratch test
Délai: At the beginning and at three months
|
To measure general shoulder range of motion.
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At the beginning and at three months
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30-second chair stand test
Délai: At the beginning and at three months
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To test leg strength and endurance.
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At the beginning and at three months
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height
Délai: At the beginning and at three months
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The distance between the lowest and highest points of a person standing upright.
|
At the beginning and at three months
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waist circumference
Délai: At the beginning and at three months
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Is used to assess central fat distribution and degree of abdominal obesity.
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At the beginning and at three months
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hip circumference
Délai: At the beginning and at three months
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It is the greatest circumference of hip
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At the beginning and at three months
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waist-to-hip ratio
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2017
Achèvement primaire (Réel)
1 novembre 2017
Achèvement de l'étude (Réel)
27 février 2018
Dates d'inscription aux études
Première soumission
22 juin 2017
Première soumission répondant aux critères de contrôle qualité
23 juin 2017
Première publication (Réel)
28 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UJaen
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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