- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
18 aprile 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
45
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Yilan, Taiwan, 26546
- Camillians Saint Mary's Hospital Luodong
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 45 anni a 64 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Control Group
maintenance of normal lifestyle in control group
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 weeks
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2013
Completamento primario (Effettivo)
31 dicembre 2013
Completamento dello studio (Effettivo)
31 dicembre 2013
Date di iscrizione allo studio
Primo inviato
29 marzo 2022
Primo inviato che soddisfa i criteri di controllo qualità
18 aprile 2022
Primo Inserito (Effettivo)
19 aprile 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 aprile 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 aprile 2022
Ultimo verificato
1 aprile 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SMHIRB-102001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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