HEART Camp Connect: A Feasibility Study

Sponsor
University of Nebraska (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985395
Collaborator
(none)
50
1
2
17.6
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HEART Camp Connect
N/A

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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
HEART Camp Connect: A Feasibility Study
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The number of potential participants without smart devices [baseline to 3 months]

    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

  1. The number of potential participants without smart devices [baseline to 6 months]

    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

  2. The number of potential participants without smart devices [3 months to 6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nebraska Medical Center Omaha Nebraska United States 68198-5330

Sponsors and Collaborators

  • University of Nebraska

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT05985395
Other Study ID Numbers:
  • 0914-21-FB
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Nebraska
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023