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Lifestyle Change for Heart Failure

N/A
Waitlist Available
Led By Christopher Suhar, MD
Research Sponsored by Scripps Center for Integrative Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 1 year after completing the intervention
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention period of 12 weeks and for 1 year after completing the program.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention period of 12 weeks and for 1 year after completing the program. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional status as measured by New York Heart Association class categories.
Functional status as measured by handgrip strength.
Functional status as measured by the 6-minute walk test.
Secondary outcome measures
Hospital Admission Rates
all-cause mortality

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lifestyle ChangeExperimental Treatment1 Intervention
Lifestyle Change

Find a Location

Who is running the clinical trial?

Scripps Center for Integrative MedicineLead Sponsor
3 Previous Clinical Trials
4,471 Total Patients Enrolled
Christopher Suhar, MDPrincipal InvestigatorScripps Center for Integrative Medicine
2 Previous Clinical Trials
164 Total Patients Enrolled
1 Trials studying Heart Failure
40 Patients Enrolled for Heart Failure
James Gray, MDStudy DirectorScripps Center for Integrative Medicine

Frequently Asked Questions

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~3 spots leftby Apr 2025