Center for Applied Research in Mental Health Care (CARMEN), Mental Health Center Glostrup, University of Copenhagen, Glostrup, Denmark.
Danish Cancer Society National Cancer Survivorship and Late Effects Research Center (CASTLE), Department of Oncology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
BMC Psychiatry. 2023 Aug 30;23(1):634. doi: 10.1186/s12888-023-05086-z.
Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months.
The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated.
The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness.
Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271-9928.
运动被推荐用于保护患有严重精神疾病的人的身体健康，并且有可能促进长期康复。包容性的运动社区为生活技能培训和社交联系提供了机会，并可能减少孤独感和内化污名化的体验，这些共同因素可能会改善个人的康复。本研究采用实用随机设计，旨在检验针对接受抗精神病药物治疗的年轻成年人（即 Vega 运动社区）量身定制的基于健身房的运动干预与常规护理相比的有效性。假设 Vega 运动社区在四个月时对个人康复的效果优于常规护理。
该试验将在丹麦的四个地点进行，将招募 400 名年龄在 18 至 35 岁之间的参与者，他们目前正在接受抗精神病药物治疗，以管理精神分裂症谱系或情感障碍。参与者将以 2:1 的比例随机分配到 Vega 运动社区或常规护理组。Vega 运动社区包括三次每周的团体基础运动课程，由认证的 Vega 指导员在商业功能性训练中心举办。四个月后，Vega 运动社区的参与者将以 1:1 的比例随机分配到最小支持与扩展支持，以保持持续的身体活动。数据将在基线、四个月、六个月和十二个月收集。主要结局是四个月时的个人康复，通过康复过程问卷进行评估。行为症状、健康相关生活质量、代谢健康和项目成本将进行评估，以进一步确定 Vega 运动社区的有效性和成本效益。最后，参与者的主要亲属的生活质量和身心健康将进行评估。
该试验的结果可能对接受抗精神病药物治疗的个体的健康、持续的身体活动和康复产生重要影响。鉴于实用设计，如果结果为阳性，心理健康护理专业人员可能会很容易地将运动作为严重精神疾病治疗的综合部分加以推广。
ClinicalTrials.gov（NCT05461885，最初注册于 2022 年 6 月 29 日）。世界卫生组织通用试验编号（UTN）：U1111-1271-9928。
