The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
NCT ID: NCT03574662
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2018-05-04
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Frailty assessment in Advanced heart failure
Subjects with advanced heart failure defined as current or recent (within the last 3 months) New York Heart Association (NYHA) class III or IV symptoms.
Frailty assessment
This assessment consists of a combination of gait speed measurement via infrared sensors as well as a grip strength assessment. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Quality of life assessment
This assessment consists of two questionnaires, Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure questionnaire. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Interventions
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Frailty assessment
This assessment consists of a combination of gait speed measurement via infrared sensors as well as a grip strength assessment. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Quality of life assessment
This assessment consists of two questionnaires, Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure questionnaire. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Eligibility Criteria
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Inclusion Criteria
* These include patients with Current NYHA class III-IV symptoms at the current time or within the preceding three months.
* Outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year OR patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (CCU)) and mention of cardiac rehab from service.
Exclusion Criteria
* Physical activity is contraindicated
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Sudhir Kushwaha
Principal Investigator
Principal Investigators
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Sudhir S Kushwaha
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.
Kulminski AM, Ukraintseva SV, Culminskaya IV, Arbeev KG, Land KC, Akushevich L, Yashin AI. Cumulative deficits and physiological indices as predictors of mortality and long life. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1053-9. doi: 10.1093/gerona/63.10.1053.
Kulminski AM, Ukraintseva SV, Kulminskaya IV, Arbeev KG, Land K, Yashin AI. Cumulative deficits better characterize susceptibility to death in elderly people than phenotypic frailty: lessons from the Cardiovascular Health Study. J Am Geriatr Soc. 2008 May;56(5):898-903. doi: 10.1111/j.1532-5415.2008.01656.x. Epub 2008 Mar 21.
Dunlay SM, Park SJ, Joyce LD, Daly RC, Stulak JM, McNallan SM, Roger VL, Kushwaha SS. Frailty and outcomes after implantation of left ventricular assist device as destination therapy. J Heart Lung Transplant. 2014 Apr;33(4):359-65. doi: 10.1016/j.healun.2013.12.014. Epub 2013 Dec 27.
Amrock LG, Deiner S. The implication of frailty on preoperative risk assessment. Curr Opin Anaesthesiol. 2014 Jun;27(3):330-5. doi: 10.1097/ACO.0000000000000065.
Thalji NM, Suri RM, Greason KL, Schaff HV. Risk assessment methods for cardiac surgery and intervention. Nat Rev Cardiol. 2014 Dec;11(12):704-14. doi: 10.1038/nrcardio.2014.136. Epub 2014 Sep 23.
Flint KM, Matlock DD, Lindenfeld J, Allen LA. Frailty and the selection of patients for destination therapy left ventricular assist device. Circ Heart Fail. 2012 Mar 1;5(2):286-93. doi: 10.1161/CIRCHEARTFAILURE.111.963215. No abstract available.
Rockwood K, Andrew M, Mitnitski A. A comparison of two approaches to measuring frailty in elderly people. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):738-43. doi: 10.1093/gerona/62.7.738.
Chung CJ, Wu C, Jones M, Kato TS, Dam TT, Givens RC, Templeton DL, Maurer MS, Naka Y, Takayama H, Mancini DM, Schulze PC. Reduced handgrip strength as a marker of frailty predicts clinical outcomes in patients with heart failure undergoing ventricular assist device placement. J Card Fail. 2014 May;20(5):310-5. doi: 10.1016/j.cardfail.2014.02.008. Epub 2014 Feb 22.
Flint KM, Matlock DD, Sundareswaran KS, Lindenfeld J, Spertus JA, Farrar DJ, Allen LA. Pre-operative health status and outcomes after continuous-flow left ventricular assist device implantation. J Heart Lung Transplant. 2013 Dec;32(12):1249-54. doi: 10.1016/j.healun.2013.09.005. Epub 2013 Oct 8.
Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8. doi: 10.1046/j.1532-5415.2002.50601.x.
Cesari M, Vellas B, Hsu FC, Newman AB, Doss H, King AC, Manini TM, Church T, Gill TM, Miller ME, Pahor M; LIFE Study Group. A physical activity intervention to treat the frailty syndrome in older persons-results from the LIFE-P study. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):216-22. doi: 10.1093/gerona/glu099. Epub 2014 Nov 11.
Clegg A, Barber S, Young J, Iliffe S, Forster A. The Home-based Older People's Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty. Age Ageing. 2014 Sep;43(5):687-95. doi: 10.1093/ageing/afu033. Epub 2014 Apr 16.
Molino-Lova R, Pasquini G, Vannetti F, Paperini A, Forconi T, Polcaro P, Zipoli R, Cecchi F, Macchi C. Effects of a structured physical activity intervention on measures of physical performance in frail elderly patients after cardiac rehabilitation: a pilot study with 1-year follow-up. Intern Emerg Med. 2013 Oct;8(7):581-9. doi: 10.1007/s11739-011-0654-z. Epub 2011 Jul 9.
Peterson MJ, Sloane R, Cohen HJ, Crowley GM, Pieper CF, Morey MC. Effect of telephone exercise counseling on frailty in older veterans: project LIFE. Am J Mens Health. 2007 Dec;1(4):326-34. doi: 10.1177/1557988307306153. Epub 2007 Oct 3.
Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
Villareal DT, Banks M, Sinacore DR, Siener C, Klein S. Effect of weight loss and exercise on frailty in obese older adults. Arch Intern Med. 2006 Apr 24;166(8):860-6. doi: 10.1001/archinte.166.8.860.
Fragala MS, Dam TT, Barber V, Judge JO, Studenski SA, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Kiel DP, Kritchevsky SB, Shardell MD, Vassileva MT, Kenny AM. Strength and function response to clinical interventions of older women categorized by weakness and low lean mass using classifications from the Foundation for the National Institute of Health sarcopenia project. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):202-9. doi: 10.1093/gerona/glu110. Epub 2014 Aug 18.
Marsh AP, Chmelo EA, Katula JA, Mihalko SL, Rejeski WJ. Should physical activity programs be tailored when older adults have compromised function? J Aging Phys Act. 2009 Jul;17(3):294-306. doi: 10.1123/japa.17.3.294.
Other Identifiers
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18-000665
Identifier Type: -
Identifier Source: org_study_id
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