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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05333484
Other study ID # SMHIRB-102001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2013
Est. completion date December 31, 2013

Study information

Verified date April 2022
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 31, 2013
Est. primary completion date December 31, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 64 Years
Eligibility 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.

Study Design


Intervention

Other:
Programed Pilates
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.

Locations

Country Name City State
Taiwan Camillians Saint Mary's Hospital Luodong Yilan

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP 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. 12 weeks
Primary The effects of 12-week Pilates program on weight measured by height scale 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. 12 weeks
Primary The effects of 12-week Pilates program on height measured by height scale 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. 12 weeks
Primary The effects of 12-week Pilates program on BMI calculated by height and weight 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. 12 weeks
Primary The effects of 12-week Pilates program on basal metabolic rate measured by MedGem Indirect Calorimeter 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. 12 weeks
Primary The effects of 12-week Pilates program on cardiovascular capacity 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. 12 weeks
Primary The effects of 12-week Pilates program on flexibility 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. 12 weeks
Primary The effects of 12-week Pilates program on muscular strength of upper limbs 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. 12 weeks
Primary The effects of 12-week Pilates program on muscular strength of lower limbs 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. 12 weeks
Primary The effects of 12-week Pilates program on core strength endurance 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. 12 weeks
Primary The effects of 12-week Pilates program on agility 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. 12 weeks
Primary The effects of 12-week Pilates program on static balance 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. 12 weeks
Primary The effects of 12-week Pilates program on dynamic balance 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. 12 weeks
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