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Trial record 3 of 130555 for:    Change

Lifestyle Change Program in Elderly Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT02303275
Recruitment Status : Unknown
Verified November 2014 by Eva Stuart, RN, Scripps Center for Integrative Medicine.
Recruitment status was:  Recruiting
First Posted : November 27, 2014
Last Update Posted : November 27, 2014
Sponsor:
Information provided by (Responsible Party):
Eva Stuart, RN, Scripps Center for Integrative Medicine

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.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Lifestyle Change Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive 12-week Lifestyle Change Program in Elderly Patients With Heart Failure
Study Start Date : May 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Lifestyle Change
Lifestyle Change
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.

Other Name: Integrative Medicine 12-week Lifestyle Change Program

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.
Other Name: Integrative Medicine Lifestyle Change Program




Primary Outcome Measures :
  1. Functional status as measured by the 6-minute walk test. [ Time Frame: After 12-weeks ]
    Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention

  2. Functional status as measured by handgrip strength. [ Time Frame: After 12-weeks ]
    Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention

  3. Functional status as measured by New York Heart Association class categories. [ Time Frame: After 12-weeks ]
    Subjects randomized to the intervention group will receive a 12-week Lifestyle Change program intervention


Secondary Outcome Measures :
  1. Hospital Admission Rates [ Time Frame: During the intervention period of 12 weeks and for 1 year after completing the program. ]
    Secondary endpoints include hospital admission rates.

  2. all-cause mortality [ Time Frame: for 1 year after completing the intervention ]
    Secondary endpoints include all-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303275


Contacts
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Contact: Christopher Suhar, MD 858-554-3330 suhar.christopher@scrippshealth.org
Contact: James Gray, MD 619-333-0195 gray.james@scrippshealth.org

Locations
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United States, California
Scripps Center for Integrative Medicine Recruiting
La Jolla, California, United States, 92037
Contact: James Gray, MD    619-333-0195    gray.james@scrippshealth.org   
Contact: Eva Stuart, RN    848-554-3340    stuart.eva@scrippshealth.org   
Principal Investigator: Christopher Suhar, MD         
Sub-Investigator: James Gray, MD         
Sub-Investigator: James Heywood, MD         
Sponsors and Collaborators
Scripps Center for Integrative Medicine
Investigators
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Principal Investigator: Christopher Suhar, MD Scripps Center for Integrative Medicine
Study Director: James Gray, MD Scripps Center for Integrative Medicine
Study Chair: James Heywood, MD Scripps CHF Clinic, Torrey Pines Campus

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Responsible Party: Eva Stuart, RN, Christopher Suhar, MD, Scripps Center for Integrative Medicine
ClinicalTrials.gov Identifier: NCT02303275     History of Changes
Other Study ID Numbers: LSCP_CHF_Suhar
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: November 27, 2014
Last Verified: November 2014
Keywords provided by Eva Stuart, RN, Scripps Center for Integrative Medicine:
Heart Failure
Congestive Heart Failure
Lifestyle Change
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases