Brach Jennifer S, Perera Subashan, Gilmore Sandra, VanSwearingen Jessie M, Brodine Deborah, Wert David, Nadkarni Neelesh K, Ricci Edmund
Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.
Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, United States.
Contemp Clin Trials. 2016 Sep;50:135-42. doi: 10.1016/j.cct.2016.08.003. Epub 2016 Aug 10.
Group exercise programs for older adults often exclude the timing and coordination of movement. Stakeholder involvement in the research process is strongly encouraged and improves the relevance and adoption of findings. We describe stakeholder involvement in the design of a clinical trial of a group-based exercise program that incorporates timing and coordination of movement into the exercises.
The study was a cluster randomized, single-blind intervention trial to compare the effects on function, disability and mobility of a standard group exercise program and the "On the Move" group exercise program in older adults residing in independent living facilities and senior apartment buildings, and attending community centers. Exercise classes were twice weekly for 12weeks delivered by study exercise leaders and facility activity staff personnel.
The primary outcomes function, disability and mobility were assessed at baseline and post-intervention. Function and disability were assessed using the Late Life Function and Disability Instrument, and mobility using the Six-Minute Walk Test and gait speed.
Patient and provider stakeholders had significant input into the study aims, design, sample, intervention, outcomes and operational considerations.
A community-based exercise program to improve walking can be developed to address both investigator identified missing components in current exercise to improve walking and stakeholder defined needs and interest for the activity program. Involvement of stakeholders substantially improves the relevance of research questions, increases the transparency of research activities and may accelerate the adoption of research into practice.
针对老年人的团体锻炼项目通常不涉及运动的时间安排和协调性。强烈鼓励利益相关者参与研究过程,这有助于提高研究结果的相关性和实用性。我们描述了利益相关者参与一项基于团体的锻炼项目临床试验设计的情况,该项目将运动的时间安排和协调性纳入到锻炼中。
该研究是一项整群随机、单盲干预试验,旨在比较标准团体锻炼项目和“动起来”团体锻炼项目对居住在独立生活设施、老年公寓并参加社区中心活动的老年人的功能、残疾程度和活动能力的影响。锻炼课程由研究锻炼负责人和设施活动工作人员每周进行两次,为期12周。
在基线和干预后对主要结果功能、残疾程度和活动能力进行评估。功能和残疾程度使用晚年功能和残疾量表进行评估,活动能力使用六分钟步行试验和步速进行评估。
患者和提供者利益相关者对研究目的、设计、样本、干预措施、结果和操作考量等方面提供了重要意见。
可以制定一项基于社区的锻炼项目来改善步行,以解决研究人员确定的当前锻炼中缺失的改善步行的组成部分,以及利益相关者确定的对该活动项目的需求和兴趣。利益相关者的参与极大地提高了研究问题的相关性,增加了研究活动的透明度,并可能加速研究成果在实践中的应用。