- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
April 18, 2022 updated by: 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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Yilan, Taiwan, 26546
- Camillians Saint Mary's Hospital Luodong
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Intervention Group
12-week programed Pilates intervention
|
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.
|
|
No Intervention: Control Group
maintenance of normal lifestyle in control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on weight measured by height scale
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on height measured by height scale
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on BMI calculated by height and weight
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on basal metabolic rate measured by MedGem Indirect Calorimeter
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on cardiovascular capacity
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on flexibility
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on muscular strength of upper limbs
Time Frame: 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.
|
12 weeks
|
|
The effects of 12-week Pilates program on muscular strength of lower limbs
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on core strength endurance
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on agility
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on static balance
Time Frame: 12 weeks
|
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
|
|
The effects of 12-week Pilates program on dynamic balance
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
December 31, 2013
Study Completion (Actual)
December 31, 2013
Study Registration Dates
First Submitted
March 29, 2022
First Submitted That Met QC Criteria
April 18, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMHIRB-102001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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