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HEART Camp Connect: A Feasibility Study

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University of Nebraska

Status

Terminated

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Behavioral: HEART Camp Connect

Study type

Interventional

Funder types

Other

Identifiers

NCT05985395
0914-21-FB

Details and patient eligibility

About

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.

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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

11 participants in 2 patient groups

HEART Camp Connect
Experimental group
Description:
Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via Zoom on a weekly basis.
Treatment:
Behavioral: HEART Camp Connect
Usual Care
No Intervention group
Description:
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Bunny J Pozehl, PhD, APRN-NP; Windy W Alonso, PhD, RN

Data sourced from clinicaltrials.gov

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