The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574662
• Other study ID #: 18-000665
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Researchers are doing this study to find out if the cardiac rehabilitation program can improve measurements of frailty and improve independence, functional abilities, and feelings about health. Frailty can be measured by weakness (as measured by hand grip strength), slowness (as measured by walking speed), low level of physical activity, low energy or self-reported exhaustion, and unintentional weight loss.

Description:

Participants with advanced heart failure with a New York Heart Association class of III or IV symptoms within the last 3 months will be identified by either their outpatient heart failure clinic notes or inpatient cardiology notes. Patients will be approached for participation if cardiac rehab is mentioned in the notes and inclusion/exclusion criteria it met. Once the consent is signed, the baseline visit will be scheduled, this will be done before cardiac rehab has started. The baseline visit include frailty assessment measured by a walk time/gait speed test and handgrip strength test, and quality of life assessment measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living with Heart Failure (MLHF) questionnaire. Patients will then attend cardiac rehabilitation for six week program. The cardiac rehab program will be designed by the individual facility due to the variation in exercise tolerance of each patient, no universal protocol will be used. After the six weeks of cardiac rehab, up to 16 weeks post-completion, the patient will return to Mayo Clinic Rochester to complete the frailty and quality of life assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Advanced heart failure patients.

• 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:

• Unable to perform physical activities due to anatomic or musculoskeletal comorbidities

• Physical activity is contraindicated

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed	The time it takes to walk a specified distance, as measured in meters per second	baseline, 6 weeks
Primary	Change in hand grip	The amount of force that the hand can squeeze, as measured in kilograms	baseline, 6 weeks
Primary	Change in Kansas City Cardiomyopathy Questionnaire	The KCCQ is a 23-item questionnaire that quantifies dyspnea, fatigue, and edema on physical, social, and emotional functions of the patient. Responses are categorized by 3 subscales (burden, limitations, and quality of life) with a possible range of scores from 0 to 100, 100 being the least burdened by their symptoms. This questionnaire independently measures the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life within a two week recall period.	baseline, 6 weeks
Primary	Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ)	The MLHFQ asks each person to indicate using a 6-point (zero to five) Likert scale how much each of 21 facets prevents them from living as they desire. The questionnaire assesses the impact of frequent physical symptoms - shortness of breath, fatigue, peripheral edema, and difficulty sleeping - and psychological symptoms of anxiety and depression. In addition, the effects of heart failure on physical and social functioning are incorporated into the measure. Since treatments might have side effects in addition to ameliorating symptoms and functional limitations produced by heart failure, questions about side effects of medications, hospital stays and costs of care are also included to help measure the overall impact of a treatment on quality of life. Although the MLHFQ incorporates relevant aspects of the key dimensions of quality of life, the questionnaire was not designed to measure any particular dimension separately.	baseline, 6 weeks
Secondary	Delay in Left Ventricular Assist Device (LVAD) placement	Number of days until LVAD placement	16 weeks
Secondary	Post surgical length of stay	Number of days subject in hospital	16 weeks