Functional FitnessNCT05333484
12-week Pilates Program on Community-dwelling Middle-aged Women
A study testing Programed Pilates in people with Functional Fitness and Health Promotion, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Fitness, Health Promotion, Exercise
- What is being tested?
- Programed Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2013to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female 45-64 years old in age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Fitness, Health Promotion, Exercise, Frail Elderly Syndrome
- Being tested
- Programed Pilates
- Keywords
- Pilates, middle-aged women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programed PilatesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Intervention Group | Experimental | 12-week programed Pilates intervention Receives: Other: Programed Pilates |
| Control Group | No intervention | maintenance of normal lifestyle in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Mar 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was quasi-experimental design with a parallel control group and the participants were recruited with convenience sampling method.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Ching Huang, National Taipei University of Nursing and Health Sciences
- Investigators
- Wen Ching Huang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333484
- Sponsor's protocol ID
- SMHIRB-102001
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Pilates Program on Basal Metabolic Rate, Body Composition, Physical Activity in Middle-aged and Elder Females
- ClinicalTrials.gov ID
- NCT05333484
- Acronym / sponsor ID
- SMHIRB-102001
- Conditions
- Functional Fitness, Health Promotion, Exercise, Frail Elderly Syndrome
- Keywords
- Pilates, middle-aged women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was quasi-experimental design with a parallel control group and the participants were recruited with convenience sampling method.
| Arm | Type | Receives |
|---|---|---|
| Pilates Intervention Group | Experimental | Other: Programed Pilates12-week programed Pilates intervention |
| Control Group | No intervention | –maintenance of normal lifestyle in control group |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female 45-64 years old in age
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programed PilatesThe 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. | Other | Pilates Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
Related trials for Functional Fitness
Not yet recruiting
Threshold-Based Versus Range-Based Exercise Intensity Prescription in Cardiac Rehabilitation
Cardiovascular Diseases, Cardiac Rehabilitation
Active, not recruitingObservational study
Respiratory Functions in Parkinson's Disease
Parkinson Disease
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Enrolling by invitation
Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol
Physical Inactivity, Sedentariness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Ching Huang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programed Pilates in people with Functional Fitness and Health Promotion, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of 12-week Pilates program on body-fat and muscular percentage measured by Physion-XP (time frame: 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.