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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Exercise Adherence Rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Exercise Adherence Rate
时间窗: 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.
次要结局
- Intervention Initiation Rate(Up to 10 weeks)
- Exercise Program Completion Rate(Up to 10 weeks)
- Study Retention Rate(Week 10)
- Physical Activity Enjoyment(Baseline and Week 10)
- Intervention Acceptability and Satisfaction(Week 10 (or at the time of early discontinuation))
- Perceived Exertion(Up to 10 weeks (monitored after every exercise session))
- Intervention Protocol Fidelity(Up to 10 weeks (monitored after every exercise session))
- Health-Related Quality of Life(Baseline and Week 10)
- Physical Activity Level(Baseline and Week 10)
- Body Mass Index (BMI)(Baseline and Week 10)
- Functional Mobility(Baseline and Week 10)
- Lower Extremity Functional Strength and Endurance(Baseline and Week 10)
- Dynamic Balance(Baseline and Week 10)
- Aerobic and Functional Capacity(Baseline and Week 10)
- Exercise Program Discontinuation Rate(Up to 10 weeks)
- Loss to Follow-up Rate(Week 10)
- Exercise-Related Complaints or Undesirable Events(Up to 10 weeks)
- Body Weight(Baseline and Week 10)
- Waist Circumference(Baseline and Week 10)
- Hip Circumference(Baseline and Week 10)
- Waist-to-Hip Ratio(Baseline and Week 10)
研究者
UMMUHAN BAS ASLAN
Professor
Pamukkale University