- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
18 april 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Yilan, Taiwan, 26546
- Camillians Saint Mary's Hospital Luodong
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 64 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: Control Group
maintenance of normal lifestyle in control group
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2013
Primärt slutförande (Faktisk)
31 december 2013
Avslutad studie (Faktisk)
31 december 2013
Studieregistreringsdatum
Först inskickad
29 mars 2022
Först inskickad som uppfyllde QC-kriterierna
18 april 2022
Första postat (Faktisk)
19 april 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SMHIRB-102001
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