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

doi:10.1067/mhj.2001.118468

American Heart Journal

Volume 142, Issue 4, October 2001, Pages 698-703

https://doi.org/10.1067/mhj.2001.118468 Get rights and content

Abstract

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. (Am Heart J 2001;142:698-703.)

Section snippets

Patient population

Patients with stable HF, NYHA-FC II-IV symptoms, 6MWT distance <500 m, and left ventricular ejection fraction (LVEF) <0.40 were eligible for enrollment into the RESOLVD pilot study. A detailed description of the exclusion criteria and other aspects of the study design has been previously published.¹⁴

Six-minute walk test

A standardized method was used to administer the 6MWT across all 60 participating centers with a course length ≥20 m. Patients were instructed to walk at their own pace while attempting to cover as

Baseline characteristics

Seven hundred sixty-eight patients were randomized to candesartan, candesartan plus enalapril, or enalapril alone and followed up for 43 weeks. At 18 weeks, 426 of the 768 patients were further randomized to metoprolol or placebo while maintaining first-stage randomization medication. Eighty-three percent of patients were male, mean age 63 ± 11 years, and 1% were in NYHA-FC I, 65% were in NYHA-FC II, 32% were in NYHA-FC III, and 2% were in NYHA-FC IV. Mean LVEF was 0.27 ± 0.10 and ischemic

Discussion

In the RESOLVD pilot study, the 6MWT was highly reliable when repeated twice at each of the 3 measurement times, was moderately inversely correlated with the NYHA-FC, and was weakly inversely correlated wtih quality of life measured with the Minnesota Living with Heart Failure questionnaire. For the responsiveness analysis, we used statistical analyses that are not commonly used in health sciences. The 6MWT was only responsive to change for patients allocated to the highest dose of candesartan

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^☆: The RESOLVD pilot study was supported by Astra Hässle, AB, Mölndal, Sweden. C. D. holds a Heart and Stroke Foundation of Canada Research Fellowship. R. S. M. held an Ontario Ministry of Health Career Scientists Award. S. Y. is the recipient of the Medical Research Council of Canada Senior Scientist Award and a Heart and Stroke Foundation of Ontario Research Chair.

^☆☆: Reprint requests: Robert S. McKelvie, MD, PhD, FRCPC, Hamilton Health Sciences Corporation–General Site, 237 Barton St E, Hamilton, Ontario L8L 2X2, Canada. E-mail: [email protected]

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Congestive Heart FailureReliability, validity, and responsiveness of the six-minute walk test in patients with heart failure☆,☆☆

Abstract

Section snippets

Patient population

Six-minute walk test

Baseline characteristics

Discussion

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J

Chest

Chest

Am J Cardiol

J Chronic Dis

J Clin Epidemiol

Am J Cardiol

Am J Cardiol

Two-, six-, and twelve-minute walking tests in respiratory disease

BMJ

Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-converting-enzyme inhibitors

N Engl J Med

Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure: the PRECISE trial

Circulation

Effects of carvedilol, a vasodilator-b-blocker, in patients with congestive heart failure due to ischemic heart disease

Circulation

Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischemic heart disease

Lancet

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