PDF(Pubmed)
Abstract：
BACKGROUND: Physical activity (PA) is beneficial for all people; however, people affected by multiple sclerosis (MS) find regular PA challenging. These people may include individuals with advanced disabilities and their care partners.
OBJECTIVE: The objective of this study is to determine the feasibility of a dyadic PA intervention for people with advanced MS and their care partners.
METHODS: This study is a randomized controlled feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate intervention condition or delayed control condition. A target of 20 people with MS-care partner dyads will be included. The outcomes will be indicators of process, resources, management, and scientific feasibility. Participant satisfaction with the intervention components will be evaluated using a satisfaction survey. The subjective experience of participation in the study will be explored using semistructured interviews.
RESULTS: The project is funded by the Consortium of Multiple Sclerosis Centers. This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The study protocol was registered with ClinicalTrials.gov in February 2020. The findings of this feasibility trial will be disseminated through presentations at community events to engage the MS population in the interpretation of our results and in the next steps. The results will also be published in peer-reviewed journals and presented to the scientific community at national and international MS conferences.
CONCLUSIONS: The data collected from this feasibility trial will be used to refine the intervention and materials in preparation for a pilot randomized controlled trial.
BACKGROUND: ClinicalTrials.gov NCT04267185; https://clinicaltrials.gov/ct2/show/NCT04267185.
UNASSIGNED: PRR1-10.2196/18410.
OBJECTIVE: The objective of this study is to determine the feasibility of a dyadic PA intervention for people with advanced MS and their care partners.
METHODS: This study is a randomized controlled feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate intervention condition or delayed control condition. A target of 20 people with MS-care partner dyads will be included. The outcomes will be indicators of process, resources, management, and scientific feasibility. Participant satisfaction with the intervention components will be evaluated using a satisfaction survey. The subjective experience of participation in the study will be explored using semistructured interviews.
RESULTS: The project is funded by the Consortium of Multiple Sclerosis Centers. This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The study protocol was registered with ClinicalTrials.gov in February 2020. The findings of this feasibility trial will be disseminated through presentations at community events to engage the MS population in the interpretation of our results and in the next steps. The results will also be published in peer-reviewed journals and presented to the scientific community at national and international MS conferences.
CONCLUSIONS: The data collected from this feasibility trial will be used to refine the intervention and materials in preparation for a pilot randomized controlled trial.
BACKGROUND: ClinicalTrials.gov NCT04267185; https://clinicaltrials.gov/ct2/show/NCT04267185.
UNASSIGNED: PRR1-10.2196/18410.
摘要：
背景：身体活动（PA）对所有人都有益；但是，受多发性硬化症（MS）影响的人发现常规PA具有挑战性。这些人可能包括高级残疾人及其护理伙伴。
目的：本研究的目的是确定对晚期MS患者及其护理伙伴进行二位PA干预的可行性。
方法：本研究是一项为期12周的干预的随机对照可行性试验，1：1分配到立即干预条件或延迟控制条件。将包括20名MS护理伴侣二元组合的目标。结果将是进程的指标，资源,管理,科学的可行性。参与者对干预组件的满意度将使用满意度调查进行评估。将使用半结构化访谈来探索参与研究的主观经验。
结果：该项目由多发性硬化症中心联盟资助。该方案得到渥太华医院研究伦理委员会（20190329-01H）和渥太华大学研究伦理委员会（H-09-19-4886）的批准。该研究方案于2020年2月在ClinicalTrials.gov注册。这项可行性试验的结果将通过社区活动的演讲进行传播，以使MS人群参与我们结果的解释和下一步。研究结果还将发表在同行评审的期刊上，并在国家和国际MS会议上提交给科学界。
结论：从该可行性试验中收集的数据将用于完善干预措施和材料，为先导随机对照试验做准备。
背景：ClinicalTrials.govNCT04267185;https://clinicaltrials.gov/ct2/show/NCT04267185。
■PRR1-10.2196/18410。
目的：本研究的目的是确定对晚期MS患者及其护理伙伴进行二位PA干预的可行性。
方法：本研究是一项为期12周的干预的随机对照可行性试验，1：1分配到立即干预条件或延迟控制条件。将包括20名MS护理伴侣二元组合的目标。结果将是进程的指标，资源,管理,科学的可行性。参与者对干预组件的满意度将使用满意度调查进行评估。将使用半结构化访谈来探索参与研究的主观经验。
结果：该项目由多发性硬化症中心联盟资助。该方案得到渥太华医院研究伦理委员会（20190329-01H）和渥太华大学研究伦理委员会（H-09-19-4886）的批准。该研究方案于2020年2月在ClinicalTrials.gov注册。这项可行性试验的结果将通过社区活动的演讲进行传播，以使MS人群参与我们结果的解释和下一步。研究结果还将发表在同行评审的期刊上，并在国家和国际MS会议上提交给科学界。
结论：从该可行性试验中收集的数据将用于完善干预措施和材料，为先导随机对照试验做准备。
背景：ClinicalTrials.govNCT04267185;https://clinicaltrials.gov/ct2/show/NCT04267185。
■PRR1-10.2196/18410。
