Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States of America.
Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States of America.
Contemp Clin Trials. 2024 Oct;145:107666. doi: 10.1016/j.cct.2024.107666. Epub 2024 Aug 17.
On the Move (OTM), a group exercise program to improve mobility in older adults, is efficacious when delivered by research staff. The next step in the development of OTM as a fully implementable intervention is to conduct an effectiveness study in which the intervention is delivered in community settings by community providers.
We describe the methods of a hybrid 1 cluster randomized, single-blind, intervention trial to compare the effectiveness of OTM to a delayed intervention control in 502 community-dwelling older adults across 44 sites. OTM classes are taught by certified instructors in the community twice a week for 12 weeks. Control centers receive no intervention for the first 12 weeks followed by 12-weeks of OTM classes. Participants are assessed at baseline, 12 and 24 weeks. The primary outcome is gait speed. Intervention fidelity, measured by adherence and competence in intervention delivery, is assessed by review of instructor intervention diaries and observation. Organizational, instructor, and participant-level factors which may impact fidelity are assessed using questionnaires, focus groups, and structured interviews.
The findings of this trial will 1) establish the effectiveness of OTM on improvements in walking and post-intervention persistence of benefits, 2) assess intervention fidelity and identify the impact of organizational, instructor, and participant level factors on fidelity, and 3) determine the extent to which fidelity moderates the effectiveness of OTM. The information derived from this project will provide valuable insight into the real-world effectiveness of OTM as a health promotion program for improving mobility in older adults.
“行动起来（OTM）”是一项针对老年人改善活动能力的团体运动项目，当由研究人员提供时，该项目是有效的。将 OTM 发展为完全可实施干预措施的下一步是进行一项有效性研究，即在社区环境中由社区提供者提供干预措施。
我们描述了一项混合 1 群随机、单盲、干预试验的方法，该试验将比较 OTM 与 44 个地点的 502 名社区居住的老年人的延迟干预对照的有效性。OTM 课程由社区认证的指导员每周两次在社区教授，为期 12 周。控制中心在前 12 周内不接受干预，然后接受 12 周的 OTM 课程。参与者在基线、12 周和 24 周进行评估。主要结果是步态速度。通过审查指导员干预日记和观察来评估干预的一致性，以衡量干预的一致性，该一致性通过参与度和干预交付能力来衡量。使用问卷、焦点小组和结构化访谈评估可能影响一致性的组织、指导员和参与者层面的因素。
该试验的结果将 1）确定 OTM 在改善行走速度和干预后获益持久性方面的有效性，2）评估干预的一致性，并确定组织、指导员和参与者层面的因素对一致性的影响，以及 3）确定一致性在多大程度上调节 OTM 的有效性。从这个项目中获得的信息将为 OTM 作为改善老年人活动能力的健康促进计划的实际效果提供有价值的见解。
