HEART Camp Connect: A Feasibility Study

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05985395
• Other study ID #: 0914-21-FB
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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