Rationale & Objective

The safety and efficacy of long-term exercise training in reducing physical functional loss in older adults with advanced CKD and comorbidity is uncertain.

Study Design

Multicenter, parallel group, randomized controlled trial.

Settings & Participants

Adults 55 years and older with estimated glomerular filtration rate (eGFR) of 15 to <45 mL/min/1.73 m² enrolled from centers in Baltimore and Boston.

Intervention

Twelve months of in-center supervised exercise training incorporating majority aerobic but also muscle strengthening activities or a group health education control intervention, randomly assigned in 1:1 ratio.

Outcome

Primary outcomes were cardiorespiratory fitness and submaximal gait at 6 and 12 months quantified by peak oxygen consumption (Vo₂peak) on graded exercise treadmill test and distance walked on the 6-minute walk test, respectively. Secondary outcomes were changes in lower extremity function, eGFR, albuminuria, glycemia, blood pressure, and body mass index.

Results

Among 99 participants, the mean age was 68 years, 62% were African American, and the mean eGFR was 33 mL/min/1.73 m²; 59% had diabetes, and 29% had coronary artery disease. Among those randomized to exercise, 59% of exercise sessions were attended in the initial 6 months. Exercise was well tolerated without excess occurrence of adverse events. At 6 months, aerobic capacity was higher among exercise participants (17.9 ± 5.5 vs 15.9 ± 7.0 mL/kg/min, P = 0.03), but the differences were not sustained at 12 months. The 6-minute walk distance improved more in the exercise group (adjusted difference: 98 feet [P = 0.02; P = 0.03 for treatment-by-time interaction]). The exercise group had greater improvements on the Timed Up and Go Test (P = 0.04) but not the Short Physical Performance Battery (P = 0.8).

Limitations

Planned sample size was not reached. Loss to follow-up and dropout were greater than anticipated.

Conclusions

Among adults aged ≥55 years with CKD stages 3b-4 and a high level of medical comorbidity, a 12-month program of in-center aerobic and resistance exercise training was safe and associated with improvements in physical functioning.

Funding

Government grants (National Institutes of Health).

Trial Registration

Registered at ClinicalTrials.gov with study number NCT01462097.

中文翻译：

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长期运动训练对成人 CKD 身体机能和心肺功能的影响：一项随机对照试验

理由和目标

长期运动训练在减少患有晚期 CKD 和合并症的老年人身体功能丧失方面的安全性和有效性尚不确定。

学习规划

多中心、平行组、随机对照试验。

设置和参与者

来自巴尔的摩和波士顿中心的55 岁及以上估计肾小球滤过率 (eGFR) 为 15 至 <45 mL/min/1.73 m ^{2的成年人。}

干涉

为期 12 个月的中心监督运动训练，包括主要有氧运动和肌肉强化活动或团体健康教育控制干预，以 1:1 的比例随机分配。

结果

主要结果是 6 个月和 12 个月时的心肺适能和次最大步态，分别通过分级运动跑步机测试中的峰值耗氧量（V o ₂峰值）和 6 分钟步行测试中的步行距离进行量化。次要结果是下肢功能、eGFR、蛋白尿、血糖、血压和体重指数的变化。

结果

在 99 名参与者中，平均年龄为 68 岁，62% 为非裔美国人，平均 eGFR 为 33 mL/min/1.73 m ²；59% 患有糖尿病，29% 患有冠状动脉疾病。在随机接受锻炼的人群中，59% 的锻炼课程在最初的 6 个月内参加。运动耐受性良好，没有过多的不良事件发生。6 个月时，运动参与者的有氧能力更高（17.9 ± 5.5 vs 15.9 ± 7.0 mL/kg/min，P  = 0.03），但差异在 12 个月时并未持续。运动组的 6 分钟步行距离改善更多（调整后的差异：98 英尺 [ P  = 0.02； 治疗与时间交互作用P = 0.03]）。练习组在 Timed Up and Go Test 上有较大进步（P  = 0.04) 但不是短期体能测试 ( P  = 0.8)。

限制

未达到计划的样本量。失访和辍学比预期的要多。

结论

在年龄≥55 岁、患有 CKD 3b-4 期和高水平内科合并症的成年人中，为期 12 个月的中心有氧运动和阻力运动训练计划是安全的，并且与身体机能的改善相关。

资金

政府补助（国立卫生研究院）。

试用注册

在 ClinicalTrials.gov 注册，研究编号为 NCT01462097。