Status:

UNKNOWN

Lifestyle Change Program in Elderly Patients With Heart Failure

Lead Sponsor:

Scripps Center for Integrative Medicine

Conditions:

Heart Failure

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

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 pa...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • Inclusions
  • Male or female, over 18
  • 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
  • History of CHF with systolic dysfunction (EF \<45%) OR History of heart failure with preserved ejection fraction (HFpEF)
  • Must have had one previous admission for acute decompensated heart failure within the past year at time of enrollment.
  • 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.
  • Labs: Complete Blood Count, Comprehensive Metabolic Panel must have been stable within the last 3 month.
  • Exercise: must be able to do some gentle exercises
  • Exclusions
  • Severe medical condition(s) that preclude participation in the Lifestyle Change Program
  • Unable to travel to the Scripps Center for Integrated Medicine Gym 3 times a week for 12 weeks
  • Severe cognitive, language, and psychosocial disabilities that prevent participation in the Lifestyle Change Program
  • 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
  • Severe untreated anemia.
  • Participation in another research study in the last month
  • Smoking

Exclusion

    Key Trial Info

    Start Date :

    May 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    May 1 2016

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT02303275

    Start Date

    May 1 2013

    End Date

    May 1 2016

    Last Update

    November 27 2014

    Active Locations (1)

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    Scripps Center for Integrative Medicine

    La Jolla, California, United States, 92037