Lifestyle Change Program in Elderly Patients With Heart Failure

NCT02303275 | Unknown

• 1 other identifier: LSCP_CHF_Suhar
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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

Keywords

Heart Failure; Congestive Heart Failure; Lifestyle Change

Outcome Measures

Primary Outcomes (3)

• Functional status as measured by the 6-minute walk test.

  Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention

  After 12-weeks

• Functional status as measured by handgrip strength.

  Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention

  After 12-weeks

• Functional status as measured by New York Heart Association class categories.

  Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention

  After 12-weeks

Secondary Outcomes (2)

• Hospital Admission Rates

  During the intervention period of 12 weeks and for 1 year after completing the program.

• all-cause mortality

  for 1 year after completing the intervention

Study Arms (1)

Lifestyle Change

OTHER

Lifestyle Change

Behavioral: Lifestyle Change

Interventions

Lifestyle Change BEHAVIORAL

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.

Also known as: Integrative Medicine 12-week Lifestyle Change Program

Lifestyle Change

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Scripps Center for Integrative Medicine: lead

Study Sites (1)

Scripps Center for Integrative Medicine

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christopher Suhar, MD

  Scripps Center for Integrative Medicine

  PRINCIPAL INVESTIGATOR

• James Gray, MD

  Scripps Center for Integrative Medicine

  STUDY DIRECTOR

• James Heywood, MD

  Scripps CHF Clinic, Torrey Pines Campus

  STUDY CHAIR

Central Study Contacts

Christopher Suhar, MD

CONTACT

858-554-3330; suhar.christopher@scrippshealth.org

James Gray, MD

CONTACT

619-333-0195; gray.james@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christopher Suhar, MD

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 27, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 27, 2014

Record last verified: 2014-11

Locations

US (1)