Rationale & Objective

Patients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk.

Study Design

Pilot randomized controlled trial.

Setting & Participants

60 dialysis patients from San Francisco dialysis clinics.

Intervention

Participants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months.

Outcomes

The primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies–Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%.

Results

49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n = 30) increased their average daily steps by 2,256 (95% CI, 978-3,537) more than the 30 controls (P < 0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) milliseconds in the intervention group as compared with controls (P = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up.

Limitations

The Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity.

Conclusions

A short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms.

Funding

Supported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology.

Trial Registration

Registered at ClinicalTrials.gov with study identifier NCT02623348.

中文翻译：

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步行干预以增加透析患者的每周步数：一项随机对照试验。

理由与目标

接受透析的患者报告其体育活动非常低。我们实施了一项试点试验，以评估基于计步器的干预措施的可行性，以收集有关其对身体活动，症状和心血管风险替代物的影响的初步证据。

学习规划

飞行员随机对照试验。

设置与参与者

来自旧金山透析诊所的60名透析患者。

干涉

参与者被随机分配为1：1，接受计步器，每周步数目标或常规护理3个月。

结果

主要结果是使用计步器测量的步数。次要结果包括使用“简短身体表现电池”进行的身体表现，36项简短形式健康调查的身体功能和活力量表，透析症状指数以及流行病学研究中心抑郁量表，以内皮功能为次要指标。心率变异性是心血管风险的探索性替代指标。目标入学率为50％，目标完成率为85％。

结果

49％的患者入组，92％的患者完成了研究。3个月后，随机分配进行干预的患者（n = 30）比30例对照组的平均每日步伐增加了2256（95％CI，978-3537）（P  <0.001）。与对照组相比，干预组的心率变异性（NN间隔的标准差）增加了14.94毫秒（95％CI，0.31-33.56）毫秒（P  = 0.05）。干预组之间在症状，身体表现或内皮功能方面没有统计学上的显着差异。在干预后的随访过程中，干预组的参与者恢复了基线步骤。

局限性

北加州的研究环境可能会限制普遍性。步行不能捕捉到全部的体育活动。

结论

短期基于计步器的干预导致透析患者的步数增加，但这种增加并没有持续。基于计步器的干预措施对于透析患者是可行的，但是需要进行进一步的研究，以解决更长时间的干预措施是否可以改善身体机能或症状。

资金

由美国肾脏基金会，美国国立卫生研究院，糖尿病和消化与肾脏疾病研究所以及国际肾脏病学会提供赠款支持。

试用注册

已在ClinicalTrials.gov上注册，研究标识为NCT02623348。