Original Study| Volume 22, ISSUE 8, P1621-1626.e2, August 2021

Validity and Utility of the Questionnaire-based FRAIL Scale in Older Patients with Heart Failure: Findings from the FRAGILE-HF



      We investigated whether the FRAIL scale questionnaire is consistent with the Fried criteria, predicts all-cause mortality, and reflects physical dysfunction in patients with heart failure (HF).


      Secondary analysis of FRAGILE-HF, a cohort study that enrolled participants from 2016 to 2018 and followed-up for 1-year of discharge.

      Setting and Participants

      A prospective multicenter cohort study in which 15 hospitals in Japan (8 university hospitals and 7 nonuniversity teaching hospitals) participated. We prospectively enrolled 1332 consecutive hospitalized patients ≥65 years old with HF and analyzed 1028 patients after excluding 304 patients with missing data on the FRAIL scale.


      The FRAIL scale, the Fried model, and physical function were measured before discharge. The endpoint was all-cause mortality.


      According to the FRAIL scale, 459 (44.6%) and 491 (47.8%) were classified as frail and prefrail, respectively. The Kappa coefficient between the FRAIL scale and the Fried criteria were 0.39 [95% confidence interval (CI) 0.34–0.44; P < .001]. The area under the receiver-operating characteristic curves for frailty diagnosed by the Fried criteria of the FRAIL scale was 0.74 (95% CI 0.71–0.76; P < .001). A total of 118 deaths occurred during 1 year of follow-up. After adjusting for the MAGGIC risk score and log-BNP, The FRAIL scale predicted all-cause mortality (hazard ratio 1.17; 95% CI 1.01–1.36; P = .035). The FRAIL scale was also associated with various physical dysfunctions that correlated with poor prognosis.

      Conclusions and Implications

      The FRAIL scale had moderate consistency with the Fried criteria, predicted all-cause mortality, and reflected clinically important physical dysfunctions.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of the American Medical Directors Association
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Shiraishi Y.
        • Kohsaka S.
        • Sato N.
        • et al.
        9-year trend in the management of acute heart failure in Japan: A report from the National Consortium of Acute Heart Failure Registries.
        J Am Heart Assoc. 2018; 7: e008687
        • Ambrosy A.P.
        • Fonarow G.C.
        • Butler J.
        • et al.
        The global health and economic burden of hospitalizations for heart failure: Lessons learned from hospitalized heart failure registries.
        J Am Coll Cardiol. 2014; 63: 1123-1133
        • Writing Group M.
        • Mozaffarian D.
        • Benjamin E.J.
        • et al.
        Heart Disease and Stroke Statistics-2016 update: A report from the American Heart Association.
        Circulation. 2016; 133: e38-e360
        • Zhang Y.
        • Yuan M.
        • Gong M.
        • et al.
        Frailty and clinical outcomes in heart failure: A systematic review and meta-analysis.
        J Am Med Dir Assoc. 2018; 19: 1003-1008.e1
        • Fried L.P.
        • Tangen C.M.
        • Walston J.
        • et al.
        Frailty in older adults: Evidence for a phenotype.
        J Gerontol A Biol Sci Med Sci. 2001; 56: M146-M156
        • Scherrenberg M.
        • Wilhelm M.
        • Hansen D.
        • et al.
        The future is now: A call for action for cardiac telerehabilitation in the COVID-19 pandemic from the secondary prevention and rehabilitation section of the European Association of Preventive Cardiology.
        Eur J Prev Cardiol. 2020; ([Epub ahead of print])
        • Ravindra A.
        • Cuff A.
        • Bernstein I.A.
        • et al.
        Musculoskeletal risk stratification tool to inform a discussion about face-to-face assessment during the COVID-19 pandemic.
        BMJ Open Sport Exerc Med. 2020; 6: e000916
        • Kemps H.M.C.
        • Brouwers R.W.M.
        • Cramer M.J.
        • et al.
        Recommendations on how to provide cardiac rehabilitation services during the COVID-19 pandemic.
        Neth Heart J. 2020; 28: 387-390
        • Morley J.E.
        • Malmstrom T.K.
        • Miller D.K.
        A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans.
        J Nutr Health Aging. 2012; 16: 601-608
        • Gleason L.J.
        • Benton E.A.
        • Alvarez-Nebreda M.L.
        • et al.
        FRAIL questionnaire screening tool and short-term outcomes in geriatric fracture patients.
        J Am Med Dir Assoc. 2017; 18: 1082-1086
        • Kojima G.
        Quick and simple FRAIL scale predicts incident activities of daily living (ADL) and instrumental ADL (IADL) disabilities: A systematic review and meta-analysis.
        J Am Med Dir Assoc. 2018; 19: 1063-1068
        • Kojima G.
        Frailty defined by FRAIL scale as a predictor of mortality: A systematic review and meta-analysis.
        J Am Med Dir Assoc. 2018; 19: 480-483
        • Rodriguez-Queralto O.
        • Formiga F.
        • Lopez-Palop R.
        • et al.
        FRAIL scale also predicts long-term outcomes in older patients with acute coronary syndromes.
        J Am Med Dir Assoc. 2020; 21: 683-687.e1
        • Matsue Y.
        • Kamiya K.
        • Saito H.
        • et al.
        Prevalence and prognostic impact of the coexistence of multiple frailty domains in elderly patients with heart failure: The FRAGILE-HF cohort study.
        Eur J Heart Fail. 2020; 22: 2112-2119
        • McKee P.A.
        • Castelli W.P.
        • McNamara P.M.
        • et al.
        The natural history of congestive heart failure: The Framingham study.
        N Engl J Med. 1971; 285: 1441-1446
        • Nozaki K.
        • Hamazaki N.
        • Kamiya K.
        • et al.
        Rising time from bed in acute phase after hospitalization predicts frailty at hospital discharge in patients with acute heart failure.
        J Cardiol. 2020; 75: 587-593
        • Guralnik J.M.
        • Simonsick E.M.
        • Ferrucci L.
        • et al.
        A short physical performance battery assessing lower extremity function: Association with self-reported disability and prediction of mortality and nursing home admission.
        J Gerontol. 1994; 49: M85-M94
        • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories
        ATS statement: Guidelines for the six-minute walk test.
        Am J Respir Crit Care Med. 2002; 166: 111-117
        • Vasunilashorn S.
        • Coppin A.K.
        • Patel K.V.
        • et al.
        Use of the short physical performance battery score to predict loss of ability to walk 400 meters: Analysis from the InCHIANTI study.
        J Gerontol A Biol Sci Med Sci. 2009; 64: 223-229
        • Guralnik J.M.
        • Ferrucci L.
        • Pieper C.F.
        • et al.
        Lower extremity function and subsequent disability: Consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery.
        J Gerontol A Biol Sci Med Sci. 2000; 55: M221-M231
        • Chen L.K.
        • Woo J.
        • Assantachai P.
        • et al.
        Asian Working Group for Sarcopenia: 2019 consensus update on sarcopenia diagnosis and treatment.
        J Am Med Dir Assoc. 2020; 21: 300-307.e2
        • Lo A.X.
        • Donnelly J.P.
        • McGwin Jr., G.
        • et al.
        Impact of gait speed and instrumental activities of daily living on all-cause mortality in adults >/=65 years with heart failure.
        Am J Cardiol. 2015; 115: 797-801
        • Afilalo J.
        • Kim S.
        • O'Brien S.
        • et al.
        Gait speed and operative mortality in older adults following cardiac surgery.
        JAMA Cardiol. 2016; 1: 314-321
        • Bittner V.
        • Weiner D.H.
        • Yusuf S.
        • et al.
        Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators.
        JAMA. 1993; 270: 1702-1707
        • Williams P.T.
        • Thompson P.D.
        The relationship of walking intensity to total and cause-specific mortality. Results from the National Walkers' Health Study.
        PLoS One. 2013; 8: e81098
        • Sawano M.
        • Shiraishi Y.
        • Kohsaka S.
        • et al.
        Performance of the MAGGIC heart failure risk score and its modification with the addition of discharge natriuretic peptides.
        ESC Heart Fail. 2018; 5: 610-619
        • Pocock S.J.
        • Ariti C.A.
        • McMurray J.J.
        • et al.
        Predicting survival in heart failure: A risk score based on 39 372 patients from 30 studies.
        Eur Heart J. 2013; 34: 1404-1413
        • DeLong E.R.
        • DeLong D.M.
        • Clarke-Pearson D.L.
        Comparing the areas under two or more correlated receiver operating characteristic curves: A nonparametric approach.
        Biometrics. 1988; 44: 837-845
        • van Buuren S.
        • Boshuizen H.C.
        • Knook D.L.
        Multiple imputation of missing blood pressure covariates in survival analysis.
        Stat Med. 1999; 18: 681-694
        • Barnard J.
        • Rubin D.
        • Miscellanea
        Small-sample degrees of freedom with multiple imputation.
        Biometrika. 1999; 86: 948-955
        • Pandey A.
        • Kitzman D.
        • Whellan D.J.
        • et al.
        Frailty among older decompensated heart failure patients: Prevalence, association with patient-centered outcomes, and efficient detection methods.
        JACC Heart Fail. 2019; 7: 1079-1088
        • Reeves G.R.
        • Whellan D.J.
        • Patel M.J.
        • et al.
        Comparison of frequency of frailty and severely impaired physical function in patients >/=60 years hospitalized with acute decompensated heart failure versus chronic stable heart failure with reduced and preserved left ventricular ejection fraction.
        Am J Cardiol. 2016; 117: 1953-1958
        • Evangelista L.
        • Doering L.V.
        • Dracup K.
        • et al.
        Compliance behaviors of elderly patients with advanced heart failure.
        J Cardiovasc Nurs. 2003; 18 (quiz 07–8): 197-206
        • Raphael C.
        • Briscoe C.
        • Davies J.
        • et al.
        Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure.
        Heart. 2007; 93: 476-482
        • Kamiya K.
        • Hamazaki N.
        • Matsue Y.
        • et al.
        Gait speed has comparable prognostic capability to six-minute walk distance in older patients with cardiovascular disease.
        Eur J Prev Cardiol. 2018; 25: 212-219
        • Tanaka S.
        • Kamiya K.
        • Hamazaki N.
        • et al.
        Short-term change in gait speed and clinical outcomes in older patients with acute heart failure.
        Circ J. 2019; 83: 1860-1867
        • Diaz de Leon Gonzalez E.
        • Gutierrez Hermosillo H.
        • Martinez Beltran J.A.
        • et al.
        Validation of the FRAIL scale in Mexican elderly: Results from the Mexican Health and Aging Study.
        Aging Clin Exp Res. 2016; 28: 901-908
        • Dong L.
        • Qiao X.
        • Tian X.
        • et al.
        Cross-cultural adaptation and validation of the FRAIL scale in Chinese community-dwelling older adults.
        J Am Med Dir Assoc. 2018; 19: 12-17
        • Duchnowski P.
        • Szymanski P.
        • Kusmierczyk M.
        • et al.
        Usefulness of FRAIL scale in heart valve diseases.
        Clin Interv Aging. 2020; 15: 1071-1075
        • Woo J.
        • Yang X.
        • Tin Lui L.
        • et al.
        Utility of the FRAIL questionnaire in detecting heart failure with preserved ejection fraction.
        J Nutr Health Aging. 2019; 23: 373-377
        • Nishimura R.A.
        • Otto C.M.
        • Bonow R.O.
        • et al.
        2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
        J Am Coll Cardiol. 2017; 70: 252-289