Kontos Pia, Alibhai Shabbir M H, Miller Karen-Lee, Brooks Dina, Colobong Romeo, Parsons Trisha, Jassal Sarbjit Vanita, Thomas Alison, Binns Malcolm, Naglie Gary
Toronto Rehabilitation Institute-University Health Network, 550 University Ave., Toronto, ON, M5G 2A2, Canada.
Dalla Lana School of Public Health, University of Toronto, 155 College St., Toronto, ON, M5T 3M7, Canada.
BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
Evidence suggests that exercise training for hemodialysis patients positively improves morbidity and mortality outcomes, yet exercise programs remain rare and are not systematically incorporated into care. We developed a research-based film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrologists, nurses, and family caregivers. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise for wellness in the context of end-stage renal disease.
METHODS/DESIGN: This 2-site parallel intervention trial will recruit 60 older hemodialysis patients from two urban hospitals. The trial will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Physical fitness and activity measures will be performed at baseline, 8 and 16 weeks, and 12 weeks after the end of the program. These include the 2-min Walk Test, Grip Strength, Duke Activity Status Index, and the Timed Up-and-Go Test, as well as wearing a pedometer for one week. Throughout the 16-week exercise program, and at 12 weeks after, we will record patients' exercise using the Godin Leisure-time Exercise Questionnaire. Patients will also keep a diary of the exercise that they do at home on non-dialysis days. Qualitative interviews, conducted at baseline, 8, and 16 weeks, will explore the impact of Fit for Dialysis on the knowledge/attitudes of patients, family caregivers, and nephrology staff regarding exercise for wellness, and in what ways the film is effective in educating, motivating, or sustaining patient exercise during dialysis, at home, and in the community.
This research will determine for whom Fit for Dialysis is effective, why, and under what conditions. If Fit for Dialysis is proven beneficial to patients, nephrology staff and family caregivers, research-based film as a model to support exercise promotion and adherence could be used to support the National Kidney Foundation's guideline recommendation (NKF-KDOQI) that exercise be incorporated into the care and treatment of dialysis patients.
NCT02754271 (ClinicalTrials.gov), retroactively registered on April 21, 2016.
有证据表明，对血液透析患者进行运动训练能积极改善发病率和死亡率，但运动项目仍然很少，且未被系统地纳入护理中。我们制作了一部基于研究的影片《适合透析》，旨在向老年血液透析患者介绍、激发并维持促进健康的运动，以及由肾病科医生、护士和家庭护理人员提供运动咨询和支持。这项临床试验的目的是确定《适合透析》是否以及以何种方式改善结局，并影响终末期肾病背景下对运动促进健康重要性的知识/态度。
方法/设计：这项双中心平行干预试验将从两家城市医院招募60名老年血液透析患者。试验将比较一家医院的影片 + 为期16周的运动项目，与另一家医院为期16周仅运动的项目。将在基线、第8周和第16周以及项目结束后12周进行体能和活动测量。这些测量包括2分钟步行测试、握力、杜克活动状态指数和定时起立行走测试，以及佩戴一周计步器。在为期16周的运动项目期间以及之后12周，我们将使用戈丁休闲时间运动问卷记录患者的运动情况。患者还将记录他们在非透析日在家中进行的运动日记。在基线、第8周和第16周进行的定性访谈将探讨《适合透析》对患者、家庭护理人员和肾病科工作人员关于运动促进健康的知识/态度的影响，以及影片在教育、激发或维持患者在透析期间、家中和社区的运动方面以何种方式有效。
这项研究将确定《适合透析》对谁有效、为何有效以及在何种条件下有效。如果《适合透析》被证明对患者、肾病科工作人员和家庭护理人员有益，那么基于研究的影片作为支持运动推广和坚持的模式，可用于支持美国国家肾脏基金会的指南建议（NKF-KDOQI），即将运动纳入透析患者的护理和治疗中。
NCT02754271（ClinicalTrials.gov），于2016年4月21日追溯注册。
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