Clinical trial NCT05985395: HEART Camp Connect: A Feasibility Study
Official title: An Intervention to Promote Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: exercise training
adherence
coaching
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Exercise Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: 3 months
Other outcomes:
measure: Smart Devices
timeFrame: Baseline
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Windy W Alonso, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: