Lifestyle Change Program in Elderly Patients With Heart Failure

Status unconfirmed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID
NCT02303275
Run by
Scripps Center for Integrative Medicine
People needed
34
Starts
2013-05-01
Expected to finish
2016-05-01
Last updated by the study team
2014-11-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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