A Study to Evaluate the Utility of Focused Frailty Interventions on Patients with Advanced Heart Failure

Overview

About this study

The purpose of this study is to assess frailty in patients being evaluated in the Congestive Heart Failure Clinic with NYHA class III-IV heart failure and to enroll these patients in cardiac rehabilitation program aimed at improving frailty and functional independence.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Exclusion Criteria:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sudhir Kushwaha, M.D.

Closed for enrollment

More information

Publications

  • The Foundation for the National Institutes of Health Sarcopenia Project developed data-driven cut-points for clinically meaningful weakness and low lean body mass. This analysis describes strength and function response to interventions based on these classifications. Read More on PubMed
  • The frailty syndrome is as a well-established condition of risk for disability. Aim of the study is to explore whether a physical activity (PA) intervention can reduce prevalence and severity of frailty in a community-dwelling elders at risk of disability. Read More on PubMed
  • Surgical risk models estimate operative outcomes while controlling for heterogeneity in 'case mix' within and between institutions. In cardiac surgery, risk models are used for patient counselling, surgical decision-making, clinical research, quality assurance and improvement, and financial reimbursement. Importantly, risk models are only as good as the databases from which they are derived; physicians and investigators should, therefore, be aware of shortcomings of clinical and administrative databases used for modelling risk estimates. The most frequently modelled outcome in cardiac surgery is 30-day mortality. However, results of randomized trials to compare conventional surgery versus transcatheter aortic valve implantation (TAVI) indicate attrition of surgical patients at 2-4 months postoperatively, suggesting that 3-month survival or mortality might be an appropriate procedural end point worth modelling. Risk models are increasingly used to identify patients who might be better-suited for TAVI. However, the appropriateness of available statistical models in this application is controversial, particularly given the tendency of risk models to misestimate operative mortality in high-risk patient subsets. Incorporation of new risk factors (such as previous mediastinal radiation, liver failure, and frailty) in future surgical or interventional risk-prediction tools might enhance model performance, and thereby optimize patient selection for TAVI. Read More on PubMed
  • frailty is a state of vulnerability to stressor events. There is uncertainty about the beneficial effects of exercise interventions for older people with frailty. The Home-based Older People's Exercise (HOPE) programme is a 12-week-exercise intervention for older people with frailty designed to improve mobility and function. Read More on PubMed
  • Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality. With the ageing population, the prognostic determinants among others include frailty, health status, disability, and cognition. These constructs are seldom measured and factored into clinical decision-making or evaluation of the prognosis of these at-risk older adults, especially as it relates to high-risk interventions. Addressing this need effectively requires increased awareness and their recognition by the treating cardiologists, their incorporation into risk prediction models when treating an elderly patient with underlying complex CVD, and timely referral for comprehensive geriatric management. Simple measures such as gait speed, the Fried score, or the Rockwood Clinical Frailty Scale can be used to assess frailty as part of routine care of elderly patients with CVD. This review examines the prevalence and outcomes associated with frailty with special emphasis in patients with CVD. Read More on PubMed
  • Frailty, a state of decreased homeostatic reserve, is characterized by dysregulation across multiple physiologic and molecular pathways. It is particularly relevant to the perioperative period, during which patients are subject to high levels of stress and inflammation. This review aims to familiarize the anesthesiologist with the most current concepts regarding frailty and its emerging role in preoperative assessment and risk stratification. Read More on PubMed
  • Heart failure (HF) is associated with the derangement of muscle structure and metabolism, contributing to exercise intolerance, frailty, and mortality. Reduced handgrip strength is associated with increased patient frailty and higher morbidity and mortality. We evaluated handgrip strength as a marker of muscle function and frailty for prediction of clinical outcomes after ventricular assist device (VAD) implantation in patients with advanced HF. Read More on PubMed
  • Frailty is recognized as a major prognostic indicator in heart failure. There has been interest in understanding whether pre-operative frailty is associated with worse outcomes after implantation of a left ventricular assist device (LVAD) as destination therapy. Read More on PubMed
  • Health status predicts adverse outcomes in heart failure and cardiac surgery patients, but its prognostic value in left ventricular assist device (LVAD) placement is unknown. Read More on PubMed
  • The objective of this prospective randomized controlled study was to compare the long-term effects of a structured physical activity intervention with those of aerobic exercises alone, in a cohort of elderly patients who had undergone elective cardiac surgery, and who were classified as frail at the end of rehabilitation based on their Short Physical Performance Battery (SPPB) score. At the end of rehabilitation, 140 frail elderly patients were randomly allocated either to the intervention group (IG) or to the control group (CG). CG participants received the usual aerobic exercise prescription, while IG participants were also taught additional exercises for strength, flexibility, balance and coordination. The improvement in SPPB score after 1 year was the outcome of the study. IG showed a significant improvement in SPPB score (9.0 ± 1.1 vs. 7.7 ± 1.4, p < 0.001), while no significant change was found in CG (7.7 ± 1.6 vs. 7.6 ± 1.5, p = 0.252). IG also showed a significantly higher proportion of participants who improved their SPPB score of at least 1 point (70 vs. 37%, p < 0.001). In conclusions, our structured physical activity intervention significantly improves the SPPB score in frail elderly patients who have undergone elective cardiac surgery. An intervention that improves the SPPB score might delay the occurrence of mobility disability. Read More on PubMed
  • Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome. Read More on PubMed
  • The purpose of this study was to determine whether a walking program supplemented by tasks designed to challenge balance and mobility (WALK+) could improve physical function more than a traditional walking program (WALK) in older adults at risk for mobility disability. 31 community-dwelling older adults (M +/- SD age = 76 +/- 5 yr; Short Physical Performance Battery [SPPB] score = 8.4 +/- 1.7) were randomized to treatment. Both interventions were 18 sessions (1 hr, 3x/wk) and progressive in intensity and duration. Physical function was assessed using the SPPB and the 400-m-walk time. A subset of participants in the WALK group who had relatively lower baseline function showed only small improvement in their SPPB scores after the intervention (0.3 +/- 0.5), whereas a subset of participants in the WALK+ group with low baseline function showed substantial improvement in their SPPB scores (2.2 +/- 0.7). These preliminary data underscore the potential importance of tailoring interventions for older adults based on baseline levels of physical function. Read More on PubMed
  • We evaluated the predictive potential for long-term (24-year) survival and longevity (85+ years) of an index of cumulative deficits (DI) and six physiological indices (pulse pressure, diastolic blood pressure, pulse rate, serum cholesterol, blood glucose, and hematocrit) measured in mid- to late life (44-88 years) for participants of the 9th and 14th Framingham Heart Study examinations. For all ages combined, the DI, pulse pressure, and blood glucose are the strongest determinants of both long-term survival and longevity, contributing cumulatively to their explanation. Diastolic blood pressure and hematocrit are less significant determinants of both of these outcomes. The pulse rate is more relevant to survival, whereas serum cholesterol is more relevant to longevity. Only the DI is a significant predictor of longevity and mortality for each 5-year age group ranging from 45 to 85 years. The DI appears to be a more important determinant of long-term risks of death and longevity than are the physiological indices. Read More on PubMed
  • To compare how well frailty measures based on a phenotypic frailty approach proposed in the Cardiovascular Health Study (CHS) and a cumulative deficits approach predict mortality. Read More on PubMed
  • This study sought to determine if telephone exercise counseling attenuates frailty in older, male veterans through increased levels of physical activity. Eighty-one elderly, male veterans (age = 78.4 +/- 4.9 years) randomized to intervention (n = 39) or combined control groups (n = 42) completed baseline and 6-month follow-up measures of gait velocity, 6-min walk, chair stands, body mass index, and physical activity. Adapting the Fried frailty model, deficits in one or more of these outcomes indicated frailty. The intervention group had a 6-month decrease of 18% in the proportion of frail to not frail participants, whereas the control groups had no change in proportions (Fisher's p = .08). Frail participants had a mean 6-month decrease in physical activity levels of 124 kilocalories/week, whereas the not frail group increased by 619 kilocalories/week (p = .07). There was a clinically meaningful change in frailty status with intensive, telephone exercise counseling. Improvement in frailty status was likely due to improvement in functional limitations. Read More on PubMed
  • Many definitions of frailty exist, but few have been directly compared. We compared the relationship between a definition of frailty based on a specific phenotype with one based on an index of deficit accumulation. Read More on PubMed
  • Obesity exacerbates the age-related decline in physical function and causes frailty in older persons. However, appropriate treatment for obese older persons is unknown. We evaluated the effects of weight loss and exercise therapy on physical function and body composition in obese older persons. Read More on PubMed
  • Although deficits in skeletal muscle strength, gait, balance, and oxygen uptake are potentially reversible causes of frailty, the efficacy of exercise in reversing frailty in community-dwelling older adults has not been proven. The aim of this study was to determine the effects of intensive exercise training (ET) on measures of physical frailty in older community-dwelling men and women. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20425089

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