Kwok JoJo Yan Yan, Kwan Jackie Cheuk Yin, Auyeung Man, Mok Vincent Chung Tong, Chan Helen Yue Lai
The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, 6/F. Esther Lee Building, Shatin, Hong Kong, Special Administrative Region of China.
The Hong Kong Society for Rehabilitation, Lam Tin, Kowloon, Hong Kong, Special Administrative Region of China.
Trials. 2017 Nov 2;18(1):509. doi: 10.1186/s13063-017-2223-x.
Psychological distress is prevalent among people with Parkinson's disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quality of life (HRQoL). The under-recognition and adverse effects of the pharmacological management of anxiety and depression among the PD population are considerable. Thus, adopting a Complementary and Alternative Management (CAM) approach to address this problem is important. Yoga, one of the most common "mind-body" CAM therapies, can improve the psychological wellbeing of people with chronic illnesses. However, limited research on the effects of yoga in people with PD has been conducted. This study will determine the effects of yoga on the psychological wellbeing of people with mild-to-moderate PD and will compare these effects with those of stretching and resistance training exercises.
A community-based, single-blind, randomized trial will be conducted. A total of 126 subjects will be recruited and randomly divided into yoga (n = 63) or stretching and resistance exercise (n = 63) groups. For 8 weeks, the yoga group will receive a weekly 90-min session of yoga, and the control group will receive a weekly 60-min session of stretching and resistance exercises. The primary outcome will be the level of psychological distress measured using the Hospital Anxiety and Depression Scale. The secondary outcomes will include the severity of motor symptoms measured by the Movement Disorders Society - Unified Parkinson's Disease Scale - Part III Motor Examination; mobility, balance, and fall risk measured by the Timed Up and Go test; spiritual wellbeing measured by the Holistic Wellbeing Scale; and HRQoL measured by the Parkinson's Disease Questionnaire-8. Assessment will be conducted at baseline, 8th, and 20th weeks of follow-ups.
This study will be the first randomized trial to compare the effect of yoga versus stretching and resistance training exercises in a PD population. Results will contribute to the value of yoga as a therapeutic option for managing psychological distress in PD patients. Multiple outcomes including psychological, physiological, and spiritual and HRQoL will also be measured to elucidate the potential mechanisms of yoga. The effect of yoga on people with chronic illnesses will further be elucidated. This information should contribute to future research, practice, and policy related to PD management.
WHO Primary Registry - Chinese Clinical Trials Registry (ChiCTR): CUHK_CCRB00522 Registered on 8 October 2016; date of approval 19 August 2016.
心理困扰在帕金森病（PD）患者中普遍存在，并会加重其运动症状，进而导致残疾加剧、医疗成本增加以及健康相关生活质量（HRQoL）下降。PD患者中焦虑和抑郁的药物治疗存在认识不足和不良反应的情况，颇为严重。因此，采用补充和替代管理（CAM）方法来解决这一问题很重要。瑜伽是最常见的“身心”CAM疗法之一，可改善慢性病患者的心理健康。然而，针对瑜伽对PD患者影响的研究有限。本研究将确定瑜伽对轻至中度PD患者心理健康的影响，并将这些影响与伸展和抗阻训练运动的影响进行比较。
将开展一项基于社区的单盲随机试验。总共招募126名受试者，并随机分为瑜伽组（n = 63）或伸展和抗阻运动组（n = 63）。为期8周，瑜伽组将每周接受一次90分钟的瑜伽课程，对照组将每周接受一次60分钟的伸展和抗阻运动课程。主要结局将是使用医院焦虑抑郁量表测量的心理困扰水平。次要结局将包括使用运动障碍协会统一帕金森病量表第三部分运动检查测量的运动症状严重程度；使用计时起立行走测试测量的活动能力、平衡能力和跌倒风险；使用整体幸福感量表测量的精神健康状况；以及使用帕金森病问卷-8测量的HRQoL。将在基线、随访的第8周和第20周进行评估。
本研究将是第一项比较瑜伽与伸展和抗阻训练运动对PD人群影响的随机试验。结果将有助于证明瑜伽作为PD患者心理困扰管理治疗选择的价值。还将测量包括心理、生理、精神和HRQoL在内的多个结局，以阐明瑜伽的潜在机制。将进一步阐明瑜伽对慢性病患者的影响。这些信息应有助于未来与PD管理相关的研究、实践和政策制定。
世界卫生组织初级注册机构——中国临床试验注册中心（ChiCTR）：CUHK_CCRB00522，于2016年10月8日注册；批准日期为2016年8月19日。
