Ferrar Katia Elizabeth, Smith Ashleigh E, Davison Kade
Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, Adelaide, Australia.
JMIR Res Protoc. 2017 Aug 1;6(8):e117. doi: 10.2196/resprot.7242.
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation.
The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load).
This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end of the intervention. Health-related outcomes (eg, physical activity, blood samples, quality of life, and functioning) will be collected at baseline, end of intervention, and 6 months after intervention completion.
This protocol was developed after 6 months of extensive stakeholder and community consultation. Enrollment began in January 2017; as of publication, 12 participants were enrolled. Baseline testing is scheduled to commence in mid-2017.
This pilot study will provide essential feasibility and acceptability data which will guide the use of active video games for people with ME/CFS to increase their physical activity levels. Physical activity promotion in this clinical population has been poorly and under-researched, and any exploration of alternative physical activity options for this population is much needed.
Australia New Zealand Clinical Trials Registry: ACTRN12616000285459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224 (Archived by WebCite at http://www.webcitation.org/6qgOLhWWf).
肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）是一种源于生物学因素的严重疾病，其特征为极度的身体和认知疲劳以及运动后不适。节奏控制是一种常见的管理可用能量并完成日常生活活动的策略；然而，很少有研究将其作为一种增加身体活动水平的策略进行调查。通常，患有ME/CFS的人在参与体育活动方面面临独特的障碍，且身体活动比健康同龄人少。因此，他们面临与身体不活动相关的健康后果的风险增加。主动式电子游戏可能是一种可行且可接受的途径，通过克服许多报告的参与障碍来提供体育活动干预。
本试点研究的主要目的是确定主动式电子游戏增加ME/CFS患者身体活动水平的可行性和可接受性。次要目的是探索节奏控制和主动式电子游戏相对于单独的节奏控制以及节奏控制加传统体育活动对增加ME/CFS成年人身体活动水平的初步效果，并探索身体活动与累积炎症负荷（应激负荷）之间的关系。
本研究将采用混合方法设计，包括一项三臂试点随机对照试验、退出访谈以及可行性和过程数据的收集。总共30名患有ME/CFS的成年人将被随机分配接受以下三种干预之一：（1）节奏控制，（2）节奏控制和传统体育活动，或（3）节奏控制和主动式电子游戏。干预持续时间为6个月，干预完成后将对参与者进行6个月的随访。干预将在参与者家中进行，活动强度将通过持续监测心率和主观用力程度评分来确定。在干预期间和结束时将收集可行性、可接受性和过程数据。与健康相关的结果（如身体活动、血液样本、生活质量和功能）将在基线、干预结束时以及干预完成后6个月收集。
本方案是在与利益相关者和社区进行6个月的广泛磋商后制定的。招募工作于2017年1月开始；截至发表时，已招募12名参与者。基线测试计划于2017年年中开始。
本试点研究将提供重要的可行性和可接受性数据，这将指导为ME/CFS患者使用主动式电子游戏来提高他们的身体活动水平。在这个临床人群中，身体活动促进方面的研究很少且不足，非常需要对该人群的替代身体活动选项进行任何探索。
澳大利亚新西兰临床试验注册中心：ACTRN12616000285459；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224（由WebCite存档于http://www.webcitation.org/6qgOLhWWf）。
