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Dance-Based Exercise Versus Clinical Pilates in Women With Overweight or Obesity (DANCE-PIL)

2026. július 30. frissítette: UMMUHAN BAS ASLAN, Pamukkale University

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:

  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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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).

  1. 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).
  2. 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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

50

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Törökország (Türkiye)
      • Denizli, Törökország (Türkiye)
        • Pamukkale University Faculty of Physical Therapy and Rehabilitation
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Negar NAKHLI, PT
        • Alkutató:
          • Raziye Şavkın, Assoc. Prof.

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: Dance-Based Exercise 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.
Aktív összehasonlító: 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.
Viselkedési: Clinical Pilates Program

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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Exercise Adherence Rate
Időkeret: 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.
Up to 10 weeks (evaluated at the end of the intervention period)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Intervention Initiation Rate
Időkeret: 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.
Up to 10 weeks
Exercise Program Completion Rate
Időkeret: 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.
Up to 10 weeks
Study Retention Rate
Időkeret: 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.
Week 10
Physical Activity Enjoyment
Időkeret: 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.
Baseline and Week 10
Intervention Acceptability and Satisfaction
Időkeret: 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).
Week 10 (or at the time of early discontinuation)
Perceived Exertion
Időkeret: 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.
Up to 10 weeks (monitored after every exercise session)
Intervention Protocol Fidelity
Időkeret: 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.
Up to 10 weeks (monitored after every exercise session)
Health-Related Quality of Life
Időkeret: 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.
Baseline and Week 10
Physical Activity Level
Időkeret: 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.
Baseline and Week 10
Body Mass Index (BMI)
Időkeret: Baseline and Week 10
Calculated using the formula: weight in kilograms divided by height in meters squared (kg/m²).
Baseline and Week 10
Functional Mobility
Időkeret: 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.
Baseline and Week 10
Lower Extremity Functional Strength and Endurance
Időkeret: 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.
Baseline and Week 10
Dynamic Balance
Időkeret: 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.
Baseline and Week 10
Aerobic and Functional Capacity
Időkeret: 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.
Baseline and Week 10
Exercise Program Discontinuation Rate
Időkeret: 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.
Up to 10 weeks
Loss to Follow-up Rate
Időkeret: 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.
Week 10
Exercise-Related Complaints or Undesirable Events
Időkeret: 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.
Up to 10 weeks
Body Weight
Időkeret: Baseline and Week 10
Body weight will be measured in kilograms using a digital scale, with participants wearing light clothing and no shoes.
Baseline and Week 10
Waist Circumference
Időkeret: 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.
Baseline and Week 10
Hip Circumference
Időkeret: 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.
Baseline and Week 10
Waist-to-Hip Ratio
Időkeret: Baseline and Week 10
Calculated by dividing waist circumference by hip circumference. Higher values indicate greater central fat distribution.
Baseline and Week 10

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Pamukkale University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 1.

Elsődleges befejezés (Becsült)

2027. május 1.

A tanulmány befejezése (Becsült)

2027. május 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 30.

Első közzététel (Tényleges)

2026. augusztus 4.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 4.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 30.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • E-60116787-020-906310

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

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Nem

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