Dance-Based Exercise Versus Clinical Pilates in Women With Overweight or Obesity (DANCE-PIL)
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
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:
- Dance-Based Exercise Group: Participants will join group dance sessions designed with low-impact, rhythmic movements to avoid joint strain.
- 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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ummuhan Baş Aslan, Prof.
- 電話番号：+902582964295
- メール：umbaslan@pau.edu.tr
研究場所
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Denizli、トルコ（Türkiye）
- Pamukkale University Faculty of Physical Therapy and Rehabilitation
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コンタクト：
- Raziye Şavkın, Assoc. Prof.
- 電話番号：+902582964253
- メール：raziyesavkin@hotmail.com
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主任研究者：
- Negar NAKHLI, PT
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副調査官：
- Raziye Şavkın, Assoc. Prof.
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Dance-Based Exercise Group
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.
|
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:
Progression is systematically advanced based on participant tolerance by increasing movement duration, choreography complexity, and tempo. |
|
アクティブコンパレータ：Clinical Pilates Group
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.
|
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:
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exercise Adherence Rate
時間枠：Up to 10 weeks (evaluated at the end of the intervention period)
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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.
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Up to 10 weeks (evaluated at the end of the intervention period)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention Initiation Rate
時間枠：Up to 10 weeks
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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.
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Up to 10 weeks
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Exercise Program Completion Rate
時間枠：Up to 10 weeks
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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.
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Up to 10 weeks
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Study Retention Rate
時間枠：Week 10
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The percentage of randomized participants who complete the final 10-week assessment.
Calculated as: (Participants completing the final assessment / Total randomized participants) x 100.
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Week 10
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Physical Activity Enjoyment
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Intervention Acceptability and Satisfaction
時間枠：Week 10 (or at the time of early discontinuation)
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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).
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Week 10 (or at the time of early discontinuation)
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Perceived Exertion
時間枠：Up to 10 weeks (monitored after every exercise session)
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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.
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Up to 10 weeks (monitored after every exercise session)
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Intervention Protocol Fidelity
時間枠：Up to 10 weeks (monitored after every exercise session)
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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.
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Up to 10 weeks (monitored after every exercise session)
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Health-Related Quality of Life
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Physical Activity Level
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Body Mass Index (BMI)
時間枠：Baseline and Week 10
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Calculated using the formula: weight in kilograms divided by height in meters squared (kg/m²).
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Baseline and Week 10
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Functional Mobility
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Lower Extremity Functional Strength and Endurance
時間枠：Baseline and Week 10
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Assessed using the 30-Second Chair Stand Test, recording the number of correct and complete stand-ups achieved within 30 seconds.
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Baseline and Week 10
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Dynamic Balance
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Aerobic and Functional Capacity
時間枠：Baseline and Week 10
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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.
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Baseline and Week 10
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Exercise Program Discontinuation Rate
時間枠：Up to 10 weeks
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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.
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Up to 10 weeks
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Loss to Follow-up Rate
時間枠：Week 10
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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.
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Week 10
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Exercise-Related Complaints or Undesirable Events
時間枠：Up to 10 weeks
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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.
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Up to 10 weeks
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Body Weight
時間枠：Baseline and Week 10
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Body weight will be measured in kilograms using a digital scale, with participants wearing light clothing and no shoes.
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Baseline and Week 10
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Waist Circumference
時間枠：Baseline and Week 10
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Waist circumference will be measured in centimeters at the midpoint between the lowest rib and the iliac crest using a non-stretchable measuring tape.
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Baseline and Week 10
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Hip Circumference
時間枠：Baseline and Week 10
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Hip circumference will be measured in centimeters at the widest part of the gluteal region using a non-stretchable measuring tape.
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Baseline and Week 10
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Waist-to-Hip Ratio
時間枠：Baseline and Week 10
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Calculated by dividing waist circumference by hip circumference.
Higher values indicate greater central fat distribution.
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Baseline and Week 10
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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