Lifestyle Change Program in Elderly Patients With Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | May 2013 |
| End Date: | May 2016 |
| Contact: | Christopher Suhar, MD |
| Email: | suhar.christopher@scrippshealth.org |
| Phone: | 858-554-3330 |
Comprehensive 12-week Lifestyle Change Program in Elderly Patients With Heart Failure
Summary
Chronic heart failure continues to be one of the highest economic burdens in the United
States, heavily influenced by frequent readmissions to the hospital. This study will examine
whether patients 65 years and older, who have NYHA class II and III heart failure, will
improve their symptoms after participating in a comprehensive 12-week lifestyle change
program. The investigators will recruit potential subjects primarily from the Scripps Clinic
heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to
medical treatment as usual or the lifestyle program. The investigators will enroll 17
subjects into each group which will provide 80% power and an alpha of 0.05.
The lifestyle change program consists of classes conducted three times a week for 12 weeks
at the Scripps Center for Integrative Medicine. Each day participants will spend about four
to five hours in a variety of classes such as monitored exercise, group support,
mindful-yoga and meditation, vegetarian cooking classes, music-centered wellness, mind-body
lectures, and resiliency training.
The primary outcomes will focus on determining functional status and physical agility using
the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the
investigators will capture subjective physical status with a self-reported questionnaire.
Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To
capture the subject's overall self-reported improvement the investigators will use a quality
of life and a depression questionnaire. Secondary endpoints include hospital admission rates
and all-cause mortality.
Chronic heart failure continues to be one of the highest economic burdens in the United
States, heavily influenced by frequent readmissions to the hospital. This study will examine
whether patients 65 years and older, who have NYHA class II and III heart failure, will
improve their symptoms after participating in a comprehensive 12-week lifestyle change
program. The investigators will recruit potential subjects primarily from the Scripps Clinic
heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to
medical treatment as usual or the lifestyle program. The investigators will enroll 17
subjects into each group which will provide 80% power and an alpha of 0.05.
The lifestyle change program consists of classes conducted three times a week for 12 weeks
at the Scripps Center for Integrative Medicine. Each day participants will spend about four
to five hours in a variety of classes such as monitored exercise, group support,
mindful-yoga and meditation, vegetarian cooking classes, music-centered wellness, mind-body
lectures, and resiliency training.
The primary outcomes will focus on determining functional status and physical agility using
the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the
investigators will capture subjective physical status with a self-reported questionnaire.
Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To
capture the subject's overall self-reported improvement the investigators will use a quality
of life and a depression questionnaire. Secondary endpoints include hospital admission rates
and all-cause mortality.
The investigators Research Question and Hypothesis is as follows:
Comprehensive, evidence-based lifestyle and psychosocial interventions over a 12-week period
(Lifestyles Change Program) can improve various objectives (6-minute walk distance, Left
Ventricular Ejection Fraction (LVEF), New York Heart Association Class, grip strength, and
cognitive function) as well as subjective (Quality of life, depression and functional
screening) measures in patients with chronic heart failure. Secondary endpoints would
include data such as hospital admission rates and all-cause mortality.
Background/ Gaps in Knowledge Chronic heart failure continues to be one of the highest
economic burdens in the United States, heavily influenced by frequent readmissions. As a
measure of performance quality, the Center of Medicare and Medicaid Services (CMS) began
publically reporting hospital risk-standardized 30-day all-cause readmission rates, among
fee-for-service beneficiaries discharged after hospitalization for heart failure from all
the US acute care hospitals (1). Previous reported averages for hospital readmission in
patients with chronic heart failure averages 25% to 30%, with some studies showing a
readmission rate of up to 45% at 6 months.
There has been significant research examining various methods to reduce hospital admissions
and improve functional capacity for patients with heart failure. Aside from published data
on patient factors associated with readmission (age, sex, race, education, diabetes, renal
disease, history of stroke, cognitive impairment, New York Heart Association (NYHA) class
level, and serum markers [blood urea nitrogen, creatinine, C-reactive protein], etc), there
have been many prospective studies evaluating readmission rates in CHF using interventions
including: specialized multi-disciplinary teams (CHF nursing staff, pharmacists, physicians,
etc), telephonic home monitoring, implantable device monitoring, various exercise programs
(intermittent vs. continuous), meditation and spirituality, and early hospital follow-up.
Attempts at creating valid statistical models to predict patients at the highest risk for
readmission used heterogeneous approaches and found substantial inconsistencies regarding
which patient characteristics were predictive. From a policy perspective, as of 2009, a
validated risk-standardized model to accurately profile hospitals using readmission rates is
unavailable in the published English-language literature to date (3). Essentially, the
identification of patients at high risk for heart failure readmission remains difficult with
no validated objective assessment. Therefore, the strategy to reduce readmissions of heart
failure patients is evolving to become a more personalized, patient-centered approach based
on specific needs of each patient. For example, studies evaluating patient vs physician and
healthcare staff perceptions for the causes of heart failure readmissions (using
standardized questionnaires), shows discrepancy in the physician's opinion vs the patient's
opinion about what factors influenced the readmission.
In essence, various aspects of the LCP have been evaluated in controlled clinical trials,
but an overall, comprehensive study evaluating multiple components as included in the LCP
has (to the investigators knowledge) not been done. Previous randomized controlled trials
have shown benefit (6-minute walk, NYHA class, etc) using cardiac rehabilitation in patients
with CHF (12). Yoga has been shown to improve exercise tolerance and positively affected
levels of inflammatory markers in patients with CHF, with trends towards improvements in QoL
(11). Education by a dietitian in patients with CHF has also been shown to result in a
significant decrease in sodium intake compared with patients who simply receive written
instructions (9). Studies have also evaluated spiritual well-being and depression in
patients with heart failure, and have shown that greater spiritual well-being, particularly
meaning/ peace was strongly associated with less depression (6). Interestingly, Tai Chi has
been used in complimentary medicine for many years in patients with cardiovascular disease.
Recently, a randomized study in 2011 showed that Tai Chi exercise improves quality of life,
mood, and exercise self-efficacy in patients with CHF (5).
The investigators goal with the currently described study is to use a comprehensive,
evidence-based Lifestyle Change Program (LCP) that incorporates all of the above individual
components in a single program, individualized to each patient's physical abilities.
Moreover, the investigators hypothesis is that such an intervention with chronic heart
failure patients will improve Quality of Life, objective cardiometabolic markers, and reduce
hospital admissions..
Comprehensive, evidence-based lifestyle and psychosocial interventions over a 12-week period
(Lifestyles Change Program) can improve various objectives (6-minute walk distance, Left
Ventricular Ejection Fraction (LVEF), New York Heart Association Class, grip strength, and
cognitive function) as well as subjective (Quality of life, depression and functional
screening) measures in patients with chronic heart failure. Secondary endpoints would
include data such as hospital admission rates and all-cause mortality.
Background/ Gaps in Knowledge Chronic heart failure continues to be one of the highest
economic burdens in the United States, heavily influenced by frequent readmissions. As a
measure of performance quality, the Center of Medicare and Medicaid Services (CMS) began
publically reporting hospital risk-standardized 30-day all-cause readmission rates, among
fee-for-service beneficiaries discharged after hospitalization for heart failure from all
the US acute care hospitals (1). Previous reported averages for hospital readmission in
patients with chronic heart failure averages 25% to 30%, with some studies showing a
readmission rate of up to 45% at 6 months.
There has been significant research examining various methods to reduce hospital admissions
and improve functional capacity for patients with heart failure. Aside from published data
on patient factors associated with readmission (age, sex, race, education, diabetes, renal
disease, history of stroke, cognitive impairment, New York Heart Association (NYHA) class
level, and serum markers [blood urea nitrogen, creatinine, C-reactive protein], etc), there
have been many prospective studies evaluating readmission rates in CHF using interventions
including: specialized multi-disciplinary teams (CHF nursing staff, pharmacists, physicians,
etc), telephonic home monitoring, implantable device monitoring, various exercise programs
(intermittent vs. continuous), meditation and spirituality, and early hospital follow-up.
Attempts at creating valid statistical models to predict patients at the highest risk for
readmission used heterogeneous approaches and found substantial inconsistencies regarding
which patient characteristics were predictive. From a policy perspective, as of 2009, a
validated risk-standardized model to accurately profile hospitals using readmission rates is
unavailable in the published English-language literature to date (3). Essentially, the
identification of patients at high risk for heart failure readmission remains difficult with
no validated objective assessment. Therefore, the strategy to reduce readmissions of heart
failure patients is evolving to become a more personalized, patient-centered approach based
on specific needs of each patient. For example, studies evaluating patient vs physician and
healthcare staff perceptions for the causes of heart failure readmissions (using
standardized questionnaires), shows discrepancy in the physician's opinion vs the patient's
opinion about what factors influenced the readmission.
In essence, various aspects of the LCP have been evaluated in controlled clinical trials,
but an overall, comprehensive study evaluating multiple components as included in the LCP
has (to the investigators knowledge) not been done. Previous randomized controlled trials
have shown benefit (6-minute walk, NYHA class, etc) using cardiac rehabilitation in patients
with CHF (12). Yoga has been shown to improve exercise tolerance and positively affected
levels of inflammatory markers in patients with CHF, with trends towards improvements in QoL
(11). Education by a dietitian in patients with CHF has also been shown to result in a
significant decrease in sodium intake compared with patients who simply receive written
instructions (9). Studies have also evaluated spiritual well-being and depression in
patients with heart failure, and have shown that greater spiritual well-being, particularly
meaning/ peace was strongly associated with less depression (6). Interestingly, Tai Chi has
been used in complimentary medicine for many years in patients with cardiovascular disease.
Recently, a randomized study in 2011 showed that Tai Chi exercise improves quality of life,
mood, and exercise self-efficacy in patients with CHF (5).
The investigators goal with the currently described study is to use a comprehensive,
evidence-based Lifestyle Change Program (LCP) that incorporates all of the above individual
components in a single program, individualized to each patient's physical abilities.
Moreover, the investigators hypothesis is that such an intervention with chronic heart
failure patients will improve Quality of Life, objective cardiometabolic markers, and reduce
hospital admissions..
Inclusions
1. Male or female, over 18
2. Able to commit to participating in the Lifestyle Change Program:
- 4 -5 hours per day
- 3 days per week
- for a total of 12-weeks
3. History of CHF with systolic dysfunction (EF <45%) OR History of heart failure with
preserved ejection fraction (HFpEF)
4. Must have had one previous admission for acute decompensated heart failure within the
past year at time of enrollment.
5. New York Heart Association (NYHA) Class II - III symptoms:
Class II: Mild symptoms (mild shortness of breath and/or angina) and slight
limitation during ordinary activity.
Class III: Marked limitation in activity due to symptoms, even during less-than-
ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
6. Labs: Complete Blood Count, Comprehensive Metabolic Panel must have been stable
within the last 3 month.
7. Exercise: must be able to do some gentle exercises
Exclusions
1. Severe medical condition(s) that preclude participation in the Lifestyle Change
Program
2. Unable to travel to the Scripps Center for Integrated Medicine Gym 3 times a week for
12 weeks
3. Severe cognitive, language, and psychosocial disabilities that prevent participation
in the Lifestyle Change Program
4. Unsafe to participate in the exercise program based on the American College of Sports
Medicine safety criteria such as:
- Refractory chest pain
- poorly controlled arrhythmias causing hemodynamic symptoms
- high degree Atrioventricular block
- pacemakers which do not permit adequate heart rate response to exercise
- significant uncorrected primary vascular disease
- isolated pulmonary hypertension
- poorly controlled symptomatic postural hypotension
- obstructive cardiomyopathies
5. Severe untreated anemia.
6. Participation in another research study in the last month
7. Smoking
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