- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498790
Equal-Volume Pilates Frequency in Women With Overweight and Obesity
Effects of Equal-Volume Pilates Training Delivered at Different Weekly Frequencies on Functional Performance, Musculoskeletal Symptoms, and Quality of Life in Women With Overweight and Obesity
The goal of this clinical trial is to learn whether doing Pilates two days per week or three days per week leads to different health outcomes in women with overweight and obesity, when the total number of exercise sessions is the same.
The study focuses on how these two Pilates schedules affect daily movement, balance, body measurements, and quality of life.
The main questions it aims to answer are:
When participants complete a total of thirty-six Pilates sessions, are there differences in functional performance between a program done three days per week for twelve weeks and a program done two days per week for eighteen weeks? Which program improves balance more? Which program improves obesity-related quality of life more? Are there differences between the two programs in waist and hip measurements, physical activity level, and musculoskeletal complaints?
Researchers will compare two supervised Pilates programs:
Pilates done three times per week for twelve weeks (thirty-six sessions total) Pilates done two times per week for eighteen weeks (thirty-six sessions total)
Participants will:
Be randomly assigned by computer to one of the two Pilates programs Take part in thirty-six supervised, mat-based Pilates sessions Have exercise intensity checked during sessions using the Borg Rating of Perceived Exertion scale Complete tests and measurements at the start and end of the study, such as walking and balance tests, body measurements, and questionnaires Be encouraged to walk at least two days per week on days without Pilates and record this activity in an exercise diary.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial was designed to examine whether the weekly frequency of supervised Pilates exercise influences functional, musculoskeletal, and quality of life outcomes in women with overweight and obesity when total exercise volume is held constant.
Participants were allocated to one of two intervention groups using computer-generated randomization. One group completed a higher-frequency, shorter-duration program consisting of three supervised Pilates sessions per week over twelve weeks, while the other group completed a lower-frequency, longer-duration program consisting of two supervised sessions per week over eighteen weeks. Both groups completed an identical total of thirty-six supervised mat-based Pilates sessions, allowing exercise frequency and temporal distribution to be examined independently of total training dose.
All Pilates sessions were delivered in a supervised group setting and followed a standardized and progressive protocol. Prior to the intervention, participants attended a familiarization session during which fundamental Pilates principles, including breathing control, core activation, postural alignment, and safe execution of exercises in different positions, were introduced. Each exercise session consisted of a warm-up period, a main Pilates exercise component, and a cool-down period. The program progressed in planned phases by gradually increasing exercise complexity and challenge through changes in body position, repetition number, holding time, and stability demands, while maintaining participant safety.
Exercise intensity during sessions was monitored using the Borg Rating of Perceived Exertion (RPE) scale, with participants encouraged to remain within a moderate to moderately high perceived intensity range. Individual modifications and support were provided when necessary to accommodate physical limitations or discomfort and to ensure correct movement execution.
In addition to the supervised Pilates sessions, participants in both groups were advised to engage in walking activity on at least two non-Pilates days per week. Adherence to both Pilates sessions and walking recommendations was monitored using an exercise diary, in which attendance, perceived exertion, and any exercise-related complaints were recorded.
Outcome assessments were conducted at baseline and after completion of the intervention period by the same physiotherapist to ensure consistency. Assessments focused on functional performance, balance, anthropometric measures, physical activity level, musculoskeletal symptoms, and obesity-specific quality of life, using validated performance tests and self-reported questionnaires.
The rationale for this study was based on evidence suggesting that total training volume is a primary determinant of exercise adaptation, while the independent contribution of weekly frequency remains unclear, particularly for low-impact, neuromuscular-focused exercise modalities such as Pilates. Individuals with overweight and obesity may also experience altered recovery capacity and musculoskeletal burden, making the optimal distribution of exercise sessions clinically relevant. By equating total supervised exercise volume, this study aimed to clarify whether distributing the same exercise dose across different weekly schedules results in distinct functional or quality-of-life outcomes.
This study was conducted in accordance with ethical principles for research involving human participants, and all participants provided written informed consent prior to participation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Denizli
-
Denizli, Denizli, Turkey (Türkiye)
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female participants aged 18-65 years.
- Body mass index (BMI) ≥27 kg/m².
- Waist circumference >88 cm.
- Ability to ambulate independently.
- Sufficient cognitive ability to understand instructions and cooperate with assessments.
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Musculoskeletal surgery within the previous six months.
- Severe cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina).
- Musculoskeletal, neuromuscular, or cognitive conditions interfering with safe participation.
- Use of medications known to affect bone metabolism.
- Pregnancy.
- Presence of metallic implants or electronic devices (e.g., pacemakers).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates 3 Days per Week
Participants assigned to this arm performed supervised mat-based Pilates exercises three times per week for twelve weeks, completing a total of thirty-six sessions.
|
Supervised mat-based Pilates exercise program designed to improve core stabilization, postural alignment, balance, and controlled movement patterns.
Sessions were delivered in a group setting and progressed gradually in difficulty.
Exercise intensity was monitored using the Borg Rating of Perceived Exertion scale to maintain moderate to moderately high intensity.
|
|
Experimental: Pilates 2 Days per Week
Participants assigned to this arm performed supervised mat-based Pilates exercises two times per week for eighteen weeks, completing a total of thirty-six sessions.
|
Supervised mat-based Pilates exercise program designed to improve core stabilization, postural alignment, balance, and controlled movement patterns.
Sessions were delivered in a group setting and progressed gradually in difficulty.
Exercise intensity was monitored using the Borg Rating of Perceived Exertion scale to maintain moderate to moderately high intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG) test time
Time Frame: aseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Time in seconds required to stand up from a chair without armrests (approximately 46 cm height), walk 3 meters, turn around, walk back, and sit down.
Lower values indicate better functional mobility.
|
aseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Single-leg stance test time
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Time in seconds the participant was able to maintain single-leg stance on the dominant and nondominant lower extremity without losing balance, swaying excessively, touching the raised foot to the ground, or stepping.
Two measurements were obtained, and the higher value was recorded.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
30-Second Chair Stand Test Repetitions
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Number of sit-to-stand repetitions completed in 30 seconds from a standard-height chair without using the arms.
Higher values indicate better lower-extremity functional performance.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Six-minute walk test distance
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Distance walked in meters during the 6-minute walk test performed along a 30-meter corridor at the participant's maximum safe walking speed without running.
Higher values indicate better submaximal functional exercise capacity.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Body mass index (BMI) calculated as body weight in kilograms divided by height in meters squared.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Waist Circumference
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Waist circumference measured in centimeters at the level of the superior iliac crest using a tape measure.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Hip circumference
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Hip circumference measured in centimeters at the widest point of the hips using a tape measure.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
International Physical Activity Questionnaire-Short Form
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Total physical activity level calculated from the IPAQ-SF as MET-minutes per week based on vigorous-intensity activity, moderate-intensity activity, and walking performed during the previous 7 days.
Sitting time was not included in the total score.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Cornell Musculoskeletal Discomfort Questionnaire
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Total score derived from the Cornell Musculoskeletal Discomfort Questionnaire based on ratings of discomfort frequency, severity, and functional interference during the previous 7 days across the assessed body regions.
Higher scores indicate greater musculoskeletal discomfort.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
|
Obesity-Specific Quality of Life Questionnaire
Time Frame: Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Total score obtained by summing the item responses of the 17-item Obesity-Specific Quality of Life Questionnaire.
|
Baseline and end of intervention (Week 12 for participants in the 3-days/week group; Week 18 for participants in the 2-days/week group)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ummuhan Baş Aslan, PhD, PT, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
- Principal Investigator: Çilem Dikmen, PT, MSc, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
- Principal Investigator: Raziye Şavkın, PT, PhD, Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Denizli, Türkiye
- Principal Investigator: Melahat Semin Fenkci, MD, Pamukkale University, Faculty of Medicine, Department of Endocrinology and Metabolism, Denizli, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-390690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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