Recruiting

Lifestyle Change Program

Sponsor:

Scripps Center for Integrative Medicine

Code:

NCT02303275

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lifestyle Change

Lifestyle Change

Study Details

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

Study ID

NCT02303275

Start date

May, 2013

Status verified date

Nov, 2014

Completion date

May, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Lifestyle Change

Lifestyle Change

Interventions

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.

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.

Primary outcome measure

  • Functional status as measured by the 6-minute walk test. [ Time Frame: After 12-weeks ]
  • Functional status as measured by handgrip strength. [ Time Frame: After 12-weeks ]
  • Functional status as measured by New York Heart Association class categories. [ Time Frame: After 12-weeks ]

Central Contacts and Locations

Locations

Scripps Center for Integrative Medicine

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Christopher Suhar, MD

More Information

Sponsor

Scripps Center for Integrative Medicine

Last update posted

Nov 27, 2014

Last verified

Nov, 2014

Keywords

  • Heart Failure
  • Congestive Heart Failure
  • Lifestyle Change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Center for Integrative Medicine on 2014-11-27.