Lifestyle Change Program in Elderly Patients With Heart Failure

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 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.

Conditions

• Heart Failure

Interventions

BEHAVIORAL

Lifestyle Change

Intervention: Lifestyles Change Program (LCP) The LCP is a 12-week multi-disciplinary program that incorporates a holistic approach to chronic disease management, which will be tailored to our study population, patients with chronic heart failure. The core of the LCP includes: Clinician, Dietician, Exercise physiologist, Counselor, Nurse Case Manager Medical oversight by board-certified Cardiologist, Exercise prescription, Stress management classes (yoga, meditation, guided imagery), Group support, lifestyle change lectures, body composition analyses, grocery store tour, cooking classes, Music Wellness, and resiliency classes.

BEHAVIORAL

Lifestyle Change

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.

Sponsors & Collaborators

• Scripps Center for Integrative Medicine

  lead OTHER

Principal Investigators

• Christopher Suhar, MD · Scripps Center for Integrative Medicine

• James Gray, MD · Scripps Center for Integrative Medicine

• James Heywood, MD · Scripps CHF Clinic, Torrey Pines Campus

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• United States

Study Locations