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- Klinische proef NCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
18 april 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
45
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
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Yilan, Taiwan, 26546
- Camillians Saint Mary's Hospital Luodong
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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
45 jaar tot 64 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
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: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: Control Group
maintenance of normal lifestyle in control group
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
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 maart 2013
Primaire voltooiing (Werkelijk)
31 december 2013
Studie voltooiing (Werkelijk)
31 december 2013
Studieregistratiedata
Eerst ingediend
29 maart 2022
Eerst ingediend dat voldeed aan de QC-criteria
18 april 2022
Eerst geplaatst (Werkelijk)
19 april 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 april 2022
Laatste update ingediend die voldeed aan QC-criteria
18 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- SMHIRB-102001
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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