Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China.
Trials. 2013 Dec 5;14:422. doi: 10.1186/1745-6215-14-422.
The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form which combines movements with breath and mind, Baduanjin may be one of the selectable effective exercises. However, evidence of Baduanjin exercise for college students has not been completely established. The primary aim of this trial is to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students through a rigorous randomization, parallel-controlled design.
METHOD/DESIGN: We will conduct a randomized, single-blind, parallel-controlled trial. A total of 222 college students from Fujian University of Traditional Chinese Medicine who meet the eligibility criteria will be recruited and randomly allocated into Baduanjin training or usual exercise control group. Baduanjin training will last 12 weeks (1 h per day, 5 days per week). The physical and psychological outcomes, including lumbar muscle strength, lumbar proprioception function, physical fitness, as well as self-reported symptom intensity, stress, self-esteem, mood, quality of life, quality of sleep, and adverse events, will be evaluated by blinded outcome assessors at baseline, 13 weeks (at the end of intervention), and 25 weeks (after the 12-week follow-up period).
This protocol presents an objective design of a randomized, single-blind trial that aims to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students. If the outcome is positive, the results will provide higher-quality evidence to better inform the college students regarding their selection about whether to receive such exercise.
Chinese Clinical Trial Registry: ChiCTR-TRC-13003329. Registration date: 18 July, 2013.
大学生的身心健康在全球范围内呈持续下降趋势。由于他们正处于一个重要的过渡期，这个时期在促进健康方面既存在机遇，也存在挑战，因此在此期间改善他们的健康状况非常重要。八段锦作为一种将动作、呼吸和意念相结合的传统中医运动形式，可能是可选择的有效运动之一。然而，八段锦运动对大学生身心健康的效果证据尚未完全确立。本试验的主要目的是通过严格的随机分组、平行对照设计，评估八段锦运动对大学生身心健康的有效性和安全性。
方法/设计：我们将进行一项随机、单盲、平行对照试验。共招募 222 名符合纳入标准的福建中医药大学大学生，并将其随机分配到八段锦训练组或常规运动对照组。八段锦训练将持续 12 周（每天 1 小时，每周 5 天）。通过盲法结局评估者在基线、13 周（干预结束时）和 25 周（12 周随访后）评估身体和心理结局，包括腰腹肌力量、腰椎本体感觉功能、体质、以及自我报告的症状严重程度、压力、自尊、情绪、生活质量、睡眠质量和不良事件。
本方案提出了一项随机、单盲试验的客观设计，旨在评估八段锦运动对大学生身心健康的有效性和安全性。如果结果为阳性，研究结果将为大学生提供更高质量的证据，以便更好地告知他们是否选择接受这种运动。
中国临床试验注册中心：ChiCTR-TRC-13003329。注册日期：2013 年 7 月 18 日。
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