Reliability, validity, and responsiveness of the six-minute walk test in patients with heart failure

Reliability, validity, and responsiveness of the six-minute walk test in patients with heart failure
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DOI:
10.1067/mhj.2001.118468
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发表时间:
2001-10-01
影响因子:
4.8
通讯作者:
Yusuf, S
Yusuf, S
中科院分区:
医学2区
文献类型:
--
作者:
Demers, C;McKelvie, RS;Yusuf, S

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背景 我们的目的是评估参加左心室功能不全策略随机评估 (RESOLVD) 试点研究的心力衰竭 (HF) 患者的 6 分钟步行试验 (6MWT) 的可靠性、有效性和反应性。方法 共有 768 名患者参加了一项多中心随机临床试验,评估坎地沙坦、依那普利和美托洛尔对左心室射血分数 (LVEF) 的影响, 6MWT 距离、神经激素和生活质量。通过标准化方法,在筛选时进行一次 6MWT,在基线、18 周和 43 周进行两次。结果 基线(组内相关系数 [ICC] = 0.90)、18 周(ICC = 0.88)和 43 周(ICC = 0.91)时的重测可靠性非常好。基线 6MWT 距离与生活质量累积评分呈弱负相关(r = -0.26,P = .0001),与纽约心脏协会功能分类(NYHA-FC)呈中度负相关(r = -0.43,P = .001)。在 RESOLVD 研究中,当使用效应大小和标准化响应方法时,6MWT 对变化没有响应。疾病特异性生活质量对接受坎地沙坦和依那普利治疗的患者的变化有反应,NYHA-FC 对坎地沙坦和依那普利组合以及单独依那普利的变化有反应,但效果较小。 6MWT、NYHA-FC 和生活质量对美托洛尔或安慰剂阶段的变化没有反应。结论 6MWT 在有 HF 症状的患者中具有高度可重复性。它与 NYHA-FC 和生活质量有一定的相关性。总体而言,在 RESOLVD 研究中,生活质量对变化的反应最为敏感,而 6MWT 和 NYHA-FC 具有可比性,但对变化的反应较差。
Background Our purpose was to evaluate the reliability, validity, and responsiveness of the 6-minute walk test (6MWT) in patients with heart failure (HF) enrolled in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) pilot study.Methods A total of 768 patients was enrolled in a multicenter randomized clinical trial evaluating the effect of candesartan, enalapril, and metoprolol on left ventricular ejection fraction (LVEF), 6MWT distance, neurohormones, and quality of life. The 6MWT was performed once at screening and twice at baseline, 18 weeks, and 43 weeks by a standardized method.Results Test-retest reliability at baseline (intraclass correlation coefficient [ICC] = 0.90), 18 weeks (ICC = 0.88), and 43 weeks (ICC = 0.91) was very good. Baseline 6MWT distance was weakly inversely correlated to the quality-of-life cumulative score (r = -0.26, P = .0001) and moderately inversely correlated to the New York Heart Association functional classification (NYHA-FC) (r = -0.43, P = .001). In the RESOLVD study, the 6MWT was not responsive to change when effect sizes and standardized response means were used. Disease-specific quality of life was responsive to change in patients treated with candesartan and enalapril and NYHA-FC was responsive to change in the candesartan and enalapril combination and for enalapril alone with small effect sizes. The 6MWT, NYHA-FC, and quality of life were not responsive to change during the metoprolol or placebo phase.Conclusions The 6MWT is highly reproducible in patients with symptoms of HF. It is somewhat correlated to NYHA-FC and quality of life. Overall, quality of life was most responsive to change, whereas 6MWT and NYHA-FC were comparable but less responsive to change in the RESOLVD study.