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HEART Camp Connect: A Feasibility Study

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEART Camp Connect
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure With Preserved Ejection Fraction focused on measuring exercise training, adherence, coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HEART Camp Connect

Usual Care

Arm 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.

Participants will have access to a virtual exercise platform or membership to a medical exercise facility.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
August 2, 2023
Last Updated
October 18, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05985395
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
exercise training, adherence, coaching

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEART Camp Connect
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
Intervention Type
Behavioral
Intervention Name(s)
HEART Camp Connect
Intervention Description
Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.
Primary Outcome Measure Information:
Title
The number of potential participants without smart devices
Description
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
Time Frame
baseline to 3 months
Secondary Outcome Measure Information:
Title
The number of potential participants without smart devices
Description
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
Time Frame
baseline to 6 months
Title
The number of potential participants without smart devices
Description
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
Time Frame
3 months to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Windy W Alonso, PhD, RN
Phone
402-559-8342
Email
windy.alonso@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bunny J Pozehl, PhD, APRN-NP
Phone
402-559-3182
Email
bpozehl@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Windy W Alonso, PhD, RN
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Windy W Alonso, PhD, RN
Phone
402-559-8342
Email
windy.alonso@unmc.edu

12. IPD Sharing Statement

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HEART Camp Connect: A Feasibility Study

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