NCT05333484

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

March 29, 2022

Last Update Submit

April 18, 2022

Conditions

Keywords

Pilatesmiddle-aged women

Outcome Measures

Primary Outcomes (13)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Pilates Intervention Group

EXPERIMENTAL

12-week programed Pilates intervention

Other: Programed Pilates

Control Group

NO INTERVENTION

maintenance of normal lifestyle in control group

Interventions

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.

Pilates Intervention Group

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female 45-64 years old in age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camillians Saint Mary's Hospital Luodong

Yilan, 26546, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wen Ching Huang, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was quasi-experimental design with a parallel control group and the participants were recruited with convenience sampling method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 19, 2022

Study Start

March 1, 2013

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations