James-Palmer Aurora M, Daneault Jean-Francois
Department of Rehabilitation and Movement Sciences, Rutgers University, Newark, NJ, USA.
Digit Health. 2022 Aug 15;8:20552076221119327. doi: 10.1177/20552076221119327. eCollection 2022 Jan-Dec.
Despite current standard treatments, persons with Parkinson disease (PD) still experience motor and non-motor symptoms that impact daily function and quality of life, warranting the investigation of additional interventions. Holistic complementary interventions such as yoga have been shown to be beneficial for persons with PD. However, there are multiple barriers to in-person interventions such as transportation difficulties and disease-related mobility impairments which may be mitigated by digital health applications. Therefore, this study's purpose was to assess the safety and feasibility of a synchronous tele-yoga intervention for persons with PD.
Sixteen participants were enrolled in a single group safety and feasibility trial. The entire study was conducted remotely and consisted of a baseline assessment followed by a six-week waiting period, then a second assessment, a six-week tele-yoga intervention period, a post-intervention assessment, a six-week follow-up period, and lastly a follow-up assessment. During the tele-yoga period, participants completed two one-on-one 30-minute tele-yoga sessions weekly for a total of 12 sessions. Primary outcomes included adverse events, adherence, technological challenges, and usability. Secondary outcomes included enjoyment and clinically relevant outcome measures assessing both motor and non-motor symptoms.
No severe adverse events were attributed to the intervention. Retention was 87.5%, assessment session adherence was 100%, and intervention session adherence was 97%. Technological challenges did not impact feasibility. The intervention was usable and enjoyable. While this study was not powered or designed to assess the efficacy of the intervention, preliminary improvements were shown for some of the clinically relevant outcome measures.
Overall, this study showed that the implementation of a synchronous one-on-one tele-yoga intervention was safe, feasible, usable, and enjoyable for persons with PD. Randomized control trials investigating its efficacy should be initiated. The study was registered with ClinicalTrials.gov (NCT04240899, https://clinicaltrials.gov/ct2/show/NCT04240899).
尽管有当前的标准治疗方法,但帕金森病(PD)患者仍会经历影响日常功能和生活质量的运动和非运动症状,这使得有必要研究其他干预措施。诸如瑜伽之类的整体补充干预措施已被证明对PD患者有益。然而,诸如交通困难和与疾病相关的行动不便等因素给面对面干预带来了多重障碍,而数字健康应用程序可能会缓解这些障碍。因此,本研究的目的是评估同步远程瑜伽干预对PD患者的安全性和可行性。
16名参与者参加了单组安全性和可行性试验。整个研究通过远程方式进行,包括一次基线评估,随后是六周的等待期,然后是第二次评估、六周的远程瑜伽干预期、干预后评估、六周的随访期,最后是随访评估。在远程瑜伽期间,参与者每周完成两次一对一的30分钟远程瑜伽课程,共12节。主要结局包括不良事件、依从性、技术挑战和可用性。次要结局包括愉悦感以及评估运动和非运动症状的临床相关结局指标。
未发现严重不良事件与干预有关。保留率为87.5%,评估阶段的依从性为100%,干预阶段的依从性为97%。技术挑战未影响可行性。该干预措施实用且令人愉悦。虽然本研究并非旨在评估该干预措施的疗效,但某些临床相关结局指标显示出初步改善。
总体而言,本研究表明,同步一对一远程瑜伽干预的实施对PD患者是安全、可行、实用且令人愉悦的。应启动调查其疗效的随机对照试验。该研究已在ClinicalTrials.gov上注册(NCT04240899,https://clinicaltrials.gov/ct2/show/NCT04240899)。