An interventional study of Dance-Based Exercise Program and Clinical Pilates Program in Overweight and Obesity, sponsored by Pamukkale University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
Purpose of the Study:
Regular physical activity is key in managing overweight and obesity, but keeping up with a program can be challenging. The main purpose of this study is to compare how well women with overweight or obesity stick to (adhere to) a 10-week dance-based exercise program versus a clinical Pilates program. The study also aims to explore how enjoyable, acceptable, and tolerable both programs are, and how they affect participants' quality of life, physical activity levels, body measurements, and physical performance.
What the Study Involves:
Female volunteers aged 18 to 60 with a body mass index (BMI) between 25 and 35 kg/m² will be randomly assigned to one of two groups:
Both programs will run for 10 weeks, with face-to-face sessions held twice a week for about 45 to 60 minutes under the supervision of a physiotherapist. Participants will be evaluated before starting the exercise programs and immediately after completing the 10-week intervention.
Background and Rationale:
While physical activity is a cornerstone of lifestyle management in overweight and obesity, the clinical success of any exercise intervention relies heavily on the participant's adherence, enjoyment, and the perceived acceptability of the program. According to Self-Determination Theory, physical activity behavior is more sustainable when driven by intrinsic motivation, enjoyment, and autonomy, rather than external factors alone. Utilizing the Theoretical Framework of Acceptability (TFA) described by Sekhon et al., this study aims to evaluate multi-component acceptability (affective attitude, burden, ethical fit, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) alongside adherence to determine the feasibility of group-based exercise modalities. This trial compares a dance-based exercise program, which leverages rhythm, music, and group interaction, with clinical Pilates, which focuses on core stabilization, postural control, and mind-body integration.
Methodology and Interventions:
This is a two-arm, parallel-group, assessor-blinded, randomized active-comparator feasibility trial. Eligible participants will be randomized in a 1:1 ratio using block randomization (managed by an independent researcher) to either the Dance-Based Exercise Group or the Clinical Pilates Group.
Both interventions will be conducted in a face-to-face, group format at Pamukkale University Faculty of Physical Therapy and Rehabilitation, supervised by an experienced physiotherapist, 2 days a week for 10 weeks (total of 20 sessions; 45-60 minutes per session).
Intensity and Monitoring:
Exercise intensity for both groups will be aimed at a low-to-moderate level, targeting a Borg Rating of Perceived Exertion (RPE, 6-20) score of 12-14. RPE, exercise-related complaints or undesirable events, session completion, and individual exercise modifications will be recorded at the end of each session.
Statistical Analysis:
Statistical analyses will be performed using IBM SPSS Statistics. Feasibility outcomes will be summarized using counts, percentages, means or medians, and 95% confidence intervals, as appropriate. Exercise adherence rates will be compared between groups using an independent-samples t-test or Mann-Whitney U test depending on distributional assumptions. Intervention initiation, program completion, study retention, loss to follow-up, program discontinuation, and exercise-related complaint rates will be compared exploratorily using the chi-square test or Fisher's exact test. Physical activity enjoyment and continuous exploratory clinical outcomes will be analyzed using analysis of covariance, with the Week 10 score as the dependent variable, group as the independent variable, and the corresponding baseline score as a covariate. Acceptability and satisfaction items will be summarized individually. Borg RPE scores across weeks will be explored using a linear mixed-effects model. Effect sizes and 95% confidence intervals will be reported, and exploratory clinical outcomes will be interpreted as hypothesis-generating.
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's planned enrollment of 50 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Participants in this arm will perform a supervised, structured, group-format, dance-based exercise program 2 days a week for 10 weeks (a total of 20 sessions, 45-60 minutes per session). The program focuses on low-impact, rhythmic, and multidirectional movements to avoid excessive joint strain. Each session includes a warm-up, a main dance phase, and a cool-down/relaxation phase.
Behavioral: Dance-Based Exercise Program
Participants in this arm will perform a supervised, structured, group-format, mat-based clinical Pilates program 2 days a week for 10 weeks (a total of 20 sessions, 45-60 minutes per session). The program focuses on core stabilization, postural control, breathing awareness, flexibility, and muscle control. Each session includes a warm-up/postural awareness phase, main Pilates exercises, and stretching/cool-down.
Behavioral: Clinical Pilates Program
A supervised, low-impact dance-based exercise program tailored specifically for women with overweight and obesity. To minimize joint loading, the program strictly avoids high-impact movements such as jumping, running, sudden direction changes, and rapid pivoting. The sessions are designed and conducted in a group format by an experienced physical therapist. The program is structured for 10 weeks, 2 sessions per week, with each session lasting 45-60 minutes. Each session consists of: 1. Warm-up (8-10 minutes): Rhythmic breathing, joint mobilization, and postural awareness. 2. Main Dance Section (30-40 minutes): Low-impact, structured choreographies involving rhythmic stepping, weight shifting, multi-directional steps, controlled trunk movements, and upper extremity coordination. 3. Cool-down (8-10 minutes): Low-intensity stretching and relaxation. Progression is systematically advanced based on participant tolerance by increasing movement duration, choreography complexity, and tempo.
A supervised, mat-based clinical Pilates program focusing on core stabilization, postural control, and muscle strength. Conducted in a group format by a physical therapist for 10 weeks (2 sessions/week, 45-60 minutes/session). Each session consists of: 1. Warm-up (8-10 mins): Breathing and postural awareness. 2. Main Section (30-40 mins): Mat exercises targeting core and extremity control. 3. Cool-down (8-10 mins): Stretching and relaxation. Progression is advanced based on participant tolerance by modifying exercise difficulty, repetitions, and introducing auxiliary equipment when required. Target intensity is kept at light-to-moderate and monitored using Borg RPE scores.
Exercise Adherence Rate
The percentage of planned exercise sessions attended by each participant among those who attend at least one session of the assigned exercise program. It is calculated using the formula: (Number of sessions attended / 20 planned sessions) × 100.
Time frame: Up to 10 weeks (evaluated at the end of the intervention period)
Intervention Initiation Rate
The percentage of randomized participants who attend at least one exercise session. Calculated as: (Number of participants attending at least one session / Total randomized participants) x 100.
Time frame: Up to 10 weeks
Exercise Program Completion Rate
The percentage of participants starting the program who complete at least 15 of the 20 planned exercise sessions. Calculated as: (Participants attending ≥15 sessions / Participants starting the program) x 100.
Time frame: Up to 10 weeks
Study Retention Rate
The percentage of randomized participants who complete the final 10-week assessment. Calculated as: (Participants completing the final assessment / Total randomized participants) x 100.
Time frame: Week 10
Physical Activity Enjoyment
Assessed using the Turkish version of the 8-item Physical Activity Enjoyment Scale. Each item is scored on a 7-point scale. The mean of the eight item scores will be calculated, resulting in a score ranging from 1 to 7, with higher scores indicating greater enjoyment of physical activity. At both baseline and Week 10, participants will be instructed to respond based on their general experience while engaging in physical activity.
Time frame: Baseline and Week 10
Intervention Acceptability and Satisfaction
Assessed using the study-specific Exercise Program Acceptability and Satisfaction Form (based on the Theoretical Framework of Acceptability). It consists of 13 items covering domains such as general satisfaction, perceived safety, tolerability, and self-efficacy, each scored from 0 (most negative) to 10 (most positive).
Time frame: Week 10 (or at the time of early discontinuation)
Perceived Exertion
Evaluated at the end of each session using the Borg Rating of Perceived Exertion (RPE) 6-20 Scale. Scores range from 6 (no exertion) to 20 (maximal exertion), used to monitor the overall session intensity.
Time frame: Up to 10 weeks (monitored after every exercise session)
Intervention Protocol Fidelity
Measured using a structured intervention checklist completed for each session, evaluating session duration, completion of the warm-up, main exercise and cool-down phases, delivery of planned exercise components, exercise intensity, individual modifications, and protocol deviations. Calculated as: (Total fidelity score obtained / Maximum planned fidelity score) × 100.
Time frame: Up to 10 weeks (monitored after every exercise session)
Health-Related Quality of Life
Assessed using the Nottingham Health Profile (NHP) Part I. It measures 6 domains: pain, emotional reactions, sleep, social isolation, physical activity, and energy. Scores for each domain range from 0 to 100, with a total profile score of 0 to 600. Higher scores indicate a worse health status.
Time frame: Baseline and Week 10
Physical Activity Level
Assessed using the International Physical Activity Questionnaire-Short Form. Walking, moderate-intensity activity, vigorous-intensity activity, and total physical activity will be calculated as MET-minutes/week. Daily sitting time will be recorded as minutes/day, and participants will be classified as having low, moderate, or high physical activity levels.
Time frame: Baseline and Week 10
Body Mass Index (BMI)
Calculated using the formula: weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline and Week 10
Functional Mobility
Assessed using the Timed Up and Go (TUG) test, recording the time (in seconds) taken by the participant to stand from a chair, walk 3 meters, turn, walk back, and sit down.
Time frame: Baseline and Week 10
Lower Extremity Functional Strength and Endurance
Assessed using the 30-Second Chair Stand Test, recording the number of correct and complete stand-ups achieved within 30 seconds.
Time frame: Baseline and Week 10
Dynamic Balance
Assessed using the Y-Balance Test. Maximum reach distances in anterior, posteromedial, and posterolateral directions will be recorded to calculate a composite reach score percentage.
Time frame: Baseline and Week 10
Aerobic and Functional Capacity
Assessed using the 2-Minute Step Test, recording the number of times the participant raises their right knee to the required mid-thigh height within a 2-minute period.
Time frame: Baseline and Week 10
Exercise Program Discontinuation Rate
The percentage of participants who attend at least one exercise session but discontinue the assigned exercise program before the end of the 10-week intervention. Calculated as: (Number of participants who discontinue the exercise program / Number of participants who start the program) × 100.
Time frame: Up to 10 weeks
Loss to Follow-up Rate
The percentage of randomized participants who do not complete the Week 10 final assessment. Calculated as: (Number of randomized participants without Week 10 assessment data / Total number of randomized participants) × 100.
Time frame: Week 10
Exercise-Related Complaints or Undesirable Events
The number and percentage of participants reporting at least one exercise-related complaint or undesirable event during or after the exercise sessions. The type of complaint, whether an exercise modification or interruption was required, and the participant's program continuation status will be recorded.
Time frame: Up to 10 weeks
Body Weight
Body weight will be measured in kilograms using a digital scale, with participants wearing light clothing and no shoes.
Time frame: Baseline and Week 10
Waist Circumference
Waist circumference will be measured in centimeters at the midpoint between the lowest rib and the iliac crest using a non-stretchable measuring tape.
Time frame: Baseline and Week 10
Hip Circumference
Hip circumference will be measured in centimeters at the widest part of the gluteal region using a non-stretchable measuring tape.
Time frame: Baseline and Week 10
Waist-to-Hip Ratio
Calculated by dividing waist circumference by hip circumference. Higher values indicate greater central fat distribution.
Time frame: Baseline and Week 10
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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