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临床试验/NCT07152028
NCT07152028已完成不适用

Effects Of 6- Versus 12-Week Supervised Multimodal Exercise on Health Outcomes and Adherence in Obese Women: A Pilot Study

Pamukkale University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年9月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Exercise adherence

研究概览

简要总结

Obesity is one of the most common health problems worldwide and is associated with many chronic diseases. Regular physical activity is known to play an important role in weight control, balance, quality of life, and mental health. However, obese individuals often have low adherence to exercise programs, and long-term maintenance of physical activity remains a major challenge.

Previous studies have shown that supervised exercise programs are effective in improving functional capacity and psychological well-being. On the other hand, home-based programs are less costly and more accessible, but adherence and effectiveness may be limited without professional supervision. To date, there is limited evidence on the optimal supervision duration needed to achieve sustainable improvements in obese women.

In the present study, it is aimed to investigate the effects of a 12-week individualized multimodal exercise program with different supervision durations (6 weeks supervised + 6 weeks home-based vs. 12 weeks fully supervised) on adherence and health outcomes in obese women. It is thought that prolonged supervision may increase exercise adherence, improve balance and functional performance, reduce depressive symptoms, and contribute positively to the quality of life. The results of this study may guide the design of future exercise programs for obesity management and provide evidence for more effective and sustainable rehabilitation approaches.

详细描述

Obesity is one of the leading public health problems worldwide and is strongly associated with cardiovascular diseases, diabetes, musculoskeletal disorders, and psychological problems. In addition to medical complications, obesity also negatively affects quality of life, daily activities, and mental well-being. According to epidemiological studies, the prevalence of obesity is steadily increasing, particularly among women, and this situation creates a serious burden on health systems.

Regular physical activity is one of the most effective non-pharmacological methods for the management of obesity. Exercise improves cardiovascular health, increases muscle strength, supports balance, reduces depressive symptoms, and contributes to weight control. Despite these benefits, adherence to exercise programs in obese individuals is often low, and sustaining physical activity over the long term remains a challenge.

Previous studies have reported that supervised exercise programs are more effective in ensuring adherence and providing functional and psychological benefits compared to unsupervised programs. However, home-based exercise programs are easier to access, more cost-effective, and provide flexibility in daily life. Nevertheless, lack of professional supervision may reduce motivation and exercise quality, leading to lower adherence and limited health benefits.

Physiotherapy and rehabilitation interventions for obesity generally include aerobic training, muscular endurance and strengthening exercises, posture and balance training, and core stabilization. Multimodal exercise programs that combine these approaches can improve both physical and psychological outcomes. Still, the optimal supervision duration in such exercise programs has not been clearly defined in the literature. While some studies emphasize the advantages of fully supervised training, others suggest that partial supervision combined with home-based practice may also be effective.

In this context, it is important to investigate whether extended supervision provides superior outcomes compared to a shorter period of supervision followed by home-based training. This information may help clinicians to design exercise programs that are both effective and sustainable for obese patients.

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

入选标准

  • Age between 18 and 60 years
  • Body mass index (BMI) > 30 kg/m²

排除标准

  • Clinically unstable cardiopulmonary disease (e.g., recent myocardial infarction, unstable angina)
  • Musculoskeletal or neuromuscular disorders
  • Cognitive impairments that could limit exercise participation
  • Use of medications affecting bone metabolism

研究组 & 干预措施

Group 1= 6-week supervised plus 6-week home-based program

Other

Participants perform a 12-week multimodal exercise program targeting balance, muscular strength, core endurance, and cardiovascular fitness. Weeks 1-6 are supervised; weeks 7-12 are home-based via a video catalogue. Walking ≥30 min on ≥2 non-training days is encouraged.

干预措施: Exercise program with supervised and home-based components (Other)

Group 2= Fully supervised 12-week program

Other

Participants perform a fully supervised 12-week multimodal exercise program including warm-up, balance, aerobic, strength, and core exercises. Walking ≥30 min on ≥2 non-training days is included.

干预措施: Fully supervised exercise program (Other)

结局指标

主要结局

Exercise adherence

时间窗: 12 weeks

Exercise adherence was calculated as the percentage of prescribed multimodal exercise sessions completed. Adherence was evaluated separately during weeks 1-6, when both groups received supervised exercise, and during weeks 7-12, when Group 1 transitioned to home-based exercise while Group 2 continued supervised exercise. Supervised-session attendance was documented by the physiotherapist. During the home-based phase, Group 1 documented completed sessions in exercise diaries, which were reviewed during weekly telephone follow-ups.

次要结局

  • Functional lower extremity strength(Baseline, 6 weeks, 12 weeks)
  • Aerobic exercise capacity(Baseline, 6 weeks, 12 weeks)
  • Balance(Baseline, 6 weeks, 12 weeks)
  • Functional mobility and dynamic balance(Baseline, 6 weeks, 12 weeks)
  • Functional lower-extremity strength and endurance(Baseline, 6 weeks, 12 weeks)
  • Functional exercise capacity(Baseline, 6 weeks, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

UMMUHAN BAS ASLAN

Prof.

Pamukkale University

研究点 (1)

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