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

NCT03574662 | Completed

• 1 other identifier: 18-000665
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

frailty; advanced

Outcome Measures

Primary Outcomes (4)

• Change in gait speed

  The time it takes to walk a specified distance, as measured in meters per second

  baseline, 6 weeks

• Change in hand grip

  The amount of force that the hand can squeeze, as measured in kilograms

  baseline, 6 weeks

• 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

• 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 Outcomes (2)

• Delay in Left Ventricular Assist Device (LVAD) placement

  16 weeks

• Post surgical length of stay

  16 weeks

Study Arms (1)

Frailty assessment in Advanced heart failure

EXPERIMENTAL

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.

Other: Frailty assessment; Other: Quality of life assessment

Interventions

Frailty assessment OTHER

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.

Frailty assessment in Advanced heart failure

Quality of life assessment OTHER

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.

Frailty assessment in Advanced heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to perform physical activities due to anatomic or musculoskeletal comorbidities
• Physical activity is contraindicated

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (19)

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  PMID: 12473001 BACKGROUND

• 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.

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• 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.

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• 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.

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  PMID: 19799101 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sudhir S Kushwaha

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: May 4, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)