HEART Camp Connect: A Feasibility Study

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Behavioral: HEART Camp Connect

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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5330
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEART Camp Connect; 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.	Behavioral: HEART Camp Connect; Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.
No Intervention: Usual Care; Participants will have access to a virtual exercise platform or membership to a medical exercise facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of potential participants without smart devices	Adherence to exercise Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of potential participants without smart devices	Adherence to exercise Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries	baseline to 6 months
The number of potential participants without smart devices	Adherence to exercise Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries	3 months to 6 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Windy W Alonso, PhD, RN, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: adherence; exercise training; coaching
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0914-21-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No