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临床试验/NCT05985395
NCT05985395终止不适用

An Intervention to Promote Exercise in Adults With Heart Failure With Preserved Ejection Fraction

University of Nebraska2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
Exercise Adherence

研究概览

简要总结

This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming. This prospective study uses a 2-group, randomized repeated measures experimental design with 3 data collection points baseline, Month 3, and Month 6.

详细描述

Potential participants will be approached at a Heart Failure clinic at an academic medical center. As a secondary recruitment strategy, we will use a database that identifies patients who previously indicated their willingness to be contacted for clinical research.

Study personnel will obtain informed consent in person in a private room or over the phone facilitated by the academic medical center electronic consent process. Once consented, participants will complete cardiopulmonary exercise testing (CPET) to guide individual exercise prescriptions and protect against risks associated with exercise. CPET results that preclude safe exercise training (arrhythmia) or those with CPET results indicating cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.

Participants will be given instruction on the use of the heart rate monitor. Participants will wear their monitor exercise sessions for heart rate monitoring. Participants will also receive educational training via videos on topics such as exercising with heart failure, how medications impact exercise, and nutrition.

Participants will be instructed to wear a heart rate monitor and strive to meet a goal of 150 minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription.

Each participant will be given access to an Omaha-based exercise coach that he/she will meet with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each week. For virtual exercise, all participants will access a Virtual Wellness Center.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of heart failure (HF) with an ejection fraction (EF) ≥50%
  • Age ≥18 years
  • English-speaking
  • Echocardiogram in prior 12 months
  • Stable pharmacologic therapy in past 30 days

排除标准

  • Score<6 on a diagnostic algorithm
  • Life-limiting illness precluding study completion
  • Clinical evidence of decompensated HF
  • Unstable angina or marked shortness of breath on exertion at <2 metabolic equivalents
  • Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker <6 weeks
  • Orthopedic or neuromuscular disorders preventing participation in aerobic exercise
  • Cardiopulmonary exercise test results that preclude safe exercise
  • Unwilling/unable to complete pre-randomization procedures
  • Pregnancy
  • Implantable cardioverter-defibrillator

结局指标

主要结局

Exercise Adherence

时间窗: 3 months

Exercise adherence is defined as a count of the number of participants meeting 120 minutes or more of moderate intensity exercise per week at the prespecified time point of 3 months.

次要结局

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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