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NCT Number: NCT07745166

Dance-Based Exercise Versus Clinical Pilates in Women With Overweight or Obesity

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:

1. Dance-Based Exercise Group: Participants will join group dance sessions designed with low-impact, rhythmic movements to avoid joint strain. 2. Clinical Pilates Group: Participants will join group Pilates sessions on mats, focusing on core stability, posture, breathing, and muscle control.

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Physical Therapy and Rehabilitation

Denizli, Turkey (Türkiye)

Location contact

Negar NAKHLI, PT

PRINCIPAL_INVESTIGATOR

Raziye Şavkın, Assoc. Prof.

CONTACT

[email protected]

+902582964253

Raziye Şavkın, Assoc. Prof.

SUB_INVESTIGATOR

About this study

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).

  • Dance-Based Exercise Program: Structurally designed to incorporate low-impact steps, rhythmic pacing, and multidirectional movements while strictly avoiding high-impact actions (such as jumping or rapid turning) to protect joints. It comprises a warm-up (8-10 min), main dance phase (30-40 min), and a cool-down/relaxation phase (8-10 min).
  • Clinical Pilates Program: Focuses on mat-based core stabilization, postural control, breathing awareness, flexibility, and muscle control. It comprises postural awareness/warm-up (8-10 min), main Pilates exercises (30-40 min), and stretching/cool-down (8-10 min).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female gender
  • Aged 18 to 60 years
  • Body Mass Index (BMI) between 25 and 35 kg/m²
  • Clinically stable
  • Able to participate regularly in the exercise program
  • Volunteering to participate and providing written informed consent

Exclusion criteria

  • Being pregnant or breastfeeding
  • Currently on an active weight loss diet
  • Receiving pharmacological treatment for obesity
  • History of bariatric surgery
  • Uncontrolled hypertension, uncontrolled diabetes, unstable cardiac disease, or serious cardiovascular risk for exercise
  • Chronic respiratory system disease significantly affecting exercise tolerance
  • Cancer, cerebrovascular disease, or severe systemic disease preventing safe exercise
  • Musculoskeletal injury, neurological disease, or significant balance/vestibular/visual problems affecting exercise participation
  • Uncontrolled psychiatric illness
  • Acute infection
  • Participating in a structured exercise program within the last 6 months
  • Transport, time, or health barriers preventing regular attendance

Treatment and study plan

Dance-Based Exercise Program

Behavioral

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:

  • Warm-up (8-10 minutes): Rhythmic breathing, joint mobilization, and postural awareness.
  • 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.
  • 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.

Clinical Pilates Program

Behavioral

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:

  • Warm-up (8-10 mins): Breathing and postural awareness.
  • Main Section (30-40 mins): Mat exercises targeting core and extremity control.
  • 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.

Primary outcomes

  1. Exercise Adherence Rate

    Time frame: Up to 10 weeks (evaluated at the end of the intervention period)

    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.

Secondary outcomes

  1. Intervention Initiation Rate

    Time frame: Up to 10 weeks

    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.

  2. Exercise Program Completion Rate

    Time frame: Up to 10 weeks

    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.

  3. Study Retention Rate

    Time frame: Week 10

    The percentage of randomized participants who complete the final 10-week assessment. Calculated as: (Participants completing the final assessment / Total randomized participants) x 100.

  4. Physical Activity Enjoyment

    Time frame: Baseline and Week 10

    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.

  5. Intervention Acceptability and Satisfaction

    Time frame: Week 10 (or at the time of early discontinuation)

    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).

  6. Perceived Exertion

    Time frame: Up to 10 weeks (monitored after every exercise session)

    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.

  7. Intervention Protocol Fidelity

    Time frame: Up to 10 weeks (monitored after every exercise session)

    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.

  8. Health-Related Quality of Life

    Time frame: Baseline and Week 10

    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.

  9. Physical Activity Level

    Time frame: Baseline and Week 10

    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.

  10. Body Mass Index (BMI)

    Time frame: Baseline and Week 10

    Calculated using the formula: weight in kilograms divided by height in meters squared (kg/m²).

  11. Functional Mobility

    Time frame: Baseline and Week 10

    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.

  12. Lower Extremity Functional Strength and Endurance

    Time frame: Baseline and Week 10

    Assessed using the 30-Second Chair Stand Test, recording the number of correct and complete stand-ups achieved within 30 seconds.

  13. Dynamic Balance

    Time frame: Baseline and Week 10

    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.

  14. Aerobic and Functional Capacity

    Time frame: Baseline and Week 10

    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.

  15. Exercise Program Discontinuation Rate

    Time frame: Up to 10 weeks

    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.

  16. Loss to Follow-up Rate

    Time frame: Week 10

    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.

  17. Exercise-Related Complaints or Undesirable Events

    Time frame: Up to 10 weeks

    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.

  18. Body Weight

    Time frame: Baseline and Week 10

    Body weight will be measured in kilograms using a digital scale, with participants wearing light clothing and no shoes.

  19. Waist Circumference

    Time frame: Baseline and Week 10

    Waist circumference will be measured in centimeters at the midpoint between the lowest rib and the iliac crest using a non-stretchable measuring tape.

  20. Hip Circumference

    Time frame: Baseline and Week 10

    Hip circumference will be measured in centimeters at the widest part of the gluteal region using a non-stretchable measuring tape.

  21. Waist-to-Hip Ratio

    Time frame: Baseline and Week 10

    Calculated by dividing waist circumference by hip circumference. Higher values indicate greater central fat distribution.

Study contacts

Contact information is provided by the study sponsor or research team.

Ummuhan Baş Aslan, Prof.

CONTACT

[email protected]

+902582964295

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Comparison of Dance-Based Exercise and Clinical Pilates in Terms of Exercise Adherence, Acceptability, and Clinical Outcomes in Women With Overweight or Obesity: A Randomized Active-Comparator Trial

Acronym: DANCE-PIL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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