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Набор скоро начнётся NCT07745166

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

Без фазы С лечением Overweight Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dance-Based Exercise Program, Clinical Pilates Program.
Кому может быть актуально
Состояния в реестре: Overweight, Obesity. Базовые параметры: 18 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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 tolera

Первичные конечные точки

  • Exercise Adherence Rate [Срок оценки: Up to 10 weeks (evaluated at the end of the intervention period)]
Вторичные конечные точки (12)
  • Intervention Initiation Rate [Срок оценки: Up to 10 weeks]
  • Exercise Program Completion Rate [Срок оценки: Up to 10 weeks]
  • Study Retention Rate [Срок оценки: Week 10]
  • Physical Activity Enjoyment [Срок оценки: Baseline and Week 10]
  • Intervention Acceptability and Satisfaction [Срок оценки: Week 10 (or at the time of early discontinuation)]
  • Perceived Exertion [Срок оценки: Up to 10 weeks (monitored after every exercise session)]
  • Intervention Protocol Fidelity [Срок оценки: Up to 10 weeks (monitored after every exercise session)]
  • Health-Related Quality of Life [Срок оценки: Baseline and Week 10]
  • Physical Activity Level [Срок оценки: Baseline and Week 10]
  • Body Mass Index (BMI) [Срок оценки: Baseline and Week 10]
  • Functional Mobility [Срок оценки: Baseline and Week 10]
  • Lower Extremity Functional Strength and Endurance [Срок оценки: Baseline and Week 10]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Pamukkale University Faculty of Physical Therapy and Rehabilitation — Denizli

Идентификаторы

NCT: NCT07745166 · E-60116787-020-906310

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗