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- Essai clinique NCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
18 avril 2022 mis à jour par: Wen Ching Huang, National Taipei University of Nursing and Health Sciences
Effects of a 12-week Pilates Program on Basal Metabolic Rate, Body Composition, Physical Activity in Middle-aged and Elder Females
The purpose of this study was to investigate the effects of a Pilates exercise intervention program on functional physical fitness in community-dwelling middle-aged women.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Based on quasi-experimental design with a parallel control group, Subjects were allocated into to intervention group and control group with convenience sampling method.
The primary outcome included body composition, basal metabolic rate, and functional physical fitness-comprising cardiovascular capacity (3-minute step test), flexibility (sit-and-reach test), muscular strength of upper limbs (grip-strength test), muscular strength of lower limbs (30 s chair stand test), core strength (bent-knee sit-up test), agility (8-foot timed up-and-go test), static balance (single-leg stance with eyes closed test), and dynamic balance (functional reach test), assessed in both groups before and after the 12-week intervention.
Type d'étude
Interventionnel
Inscription (Réel)
45
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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Yilan, Taïwan, 26546
- Camillians Saint Mary's Hospital Luodong
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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
45 ans à 64 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Female 45-64 years old in age
Exclusion Criteria:
- cognitive-function impairment
- spinal disease
- unsuitability for engaging in physical activity (e.g., because of severe cardiovascular disease)
- muscular strength affected by medication for nervous system diseases.
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: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Pilates Intervention Group
12-week programed Pilates intervention
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The 60 min Pilates sessions were held twice a week for 12 weeks.
Each session included three stages: 10 min of warm-up exercises, 40 min of floor-based Pilates training, and 10 min of cool-down exercises.
Each stage was adjusted according to the participants' physical capacity.
Only participants with an attendance rate of > 80% were included in the final sample.
The content of the exercise program was determined according to their muscular strength, flexibility, and fitness levels.
The training course was divided into three levels: elementary, intermediate, and advanced.
Each motion was performed in conjunction with a specific breathing pattern for effective muscle activations of each exercise.
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Aucune intervention: Control Group
maintenance of normal lifestyle in control group
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP
Délai: 12 weeks
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The body composition is simultaneously measured by Physion-XP for outcome measures including body-fat percentage (%), and muscular percentage (%) in the upper and lower limbs.
The higher muscular percentage and lower body-fat percentage would be associated with appropriate fitness.
Changes of body-fat percentage, and muscular percentage in the upper and lower limbs measures will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on weight measured by height scale
Délai: 12 weeks
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The body weight (kilograms) is measured by height scale.
The higher body weight would be associated with obesity and the he lower weight without diseases and medical conditoins means the better fitness.
Changes of body weight measures will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on height measured by height scale
Délai: 12 weeks
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The height (meters) is measured by height scale.
The higher height would be associated with body growth.
Changes of height measures will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on BMI calculated by height and weight
Délai: 12 weeks
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The Body Mass Index (BMI) is calculated by weight and height measures.
Body Mass Index is a simple calculation using a person's height and weight.
The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared.
The higher BMI would be associated with obesity.
Changes of BMI measures will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on basal metabolic rate measured by MedGem Indirect Calorimeter
Délai: 12 weeks
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The handheld MedGem Indirect Calorimeter is used to measure basal metabolic rate.
The higher outcomes mean the higher basal metabolic rate.
Changes of basal metabolic rate will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on cardiovascular capacity
Délai: 12 weeks
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The cardiovascular capacity is evaluated by 3-minute step test.
The higher index of cardiovascular capacity means the higher cardiovascular fitness.
Changes of cardiovascular capacity will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on flexibility
Délai: 12 weeks
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The flexibility is evaluated by sit-and-reach test.
The longer distance of test means the higher flexibility fitness.
Changes of flexibility will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on muscular strength of upper limbs
Délai: 12 weeks
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The muscular strength of upper limbs is evaluated by grip-strength test.
The higher strength of test means the higher strength fitness in upper limbs.
Changes of muscular strength of upper limbs will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on muscular strength of lower limbs
Délai: 12 weeks
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The muscular strength of lower limbs is evaluated by 30 s chair stand test.
The higher repetitions mean the higher strength fitness in lower limbs.
Changes of functional physical fitness will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on core strength endurance
Délai: 12 weeks
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The core strength endurance is evaluated by 1-minute bent-knee sit-up test.
The higher repetitions mean the higher core strength endurance fitness.
Changes of core strength endurance will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on agility
Délai: 12 weeks
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The agility is evaluated by 8-foot timed up-and-go test.
The shorter time for the task means the higher agility fitness.
Changes of agility will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on static balance
Délai: 12 weeks
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The static balance is evaluated by single-leg stance with eyes closed test.
The longer time for single-leg stance with eyes closed means the higher static balance fitness.
Changes of static balance will be assessed at the 0 week, and 12 weeks.
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12 weeks
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The effects of 12-week Pilates program on dynamic balance
Délai: 12 weeks
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The dynamic balance is evaluated by functional reach test.
The longer distance reach with stability means the higher dynamic balance fitness.
Changes of dynamic balance will be assessed at the 0 week, and 12 weeks.
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12 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
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 mars 2013
Achèvement primaire (Réel)
31 décembre 2013
Achèvement de l'étude (Réel)
31 décembre 2013
Dates d'inscription aux études
Première soumission
29 mars 2022
Première soumission répondant aux critères de contrôle qualité
18 avril 2022
Première publication (Réel)
19 avril 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- SMHIRB-102001
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .