NCT05985395

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 20, 2025

Completed
Last Updated

December 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

August 2, 2023

Results QC Date

December 30, 2024

Last Update Submit

November 24, 2025

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

exercise trainingadherencecoaching

Outcome Measures

Primary Outcomes (1)

  • Exercise Adherence

    Exercise adherence is defined as a count of the number of participants meeting 120 minutes or more of moderate intensity exercise per week at the prespecified time point of 3 months.

    3 months

Secondary Outcomes (1)

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    3 months

Other Outcomes (1)

  • Smart Devices

    Baseline

Study Arms (2)

HEART Camp Connect

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

HEART Camp ConnectBEHAVIORAL

Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.

HEART Camp Connect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5330, United States

Location

Limitations and Caveats

We initially planned to enroll 25 participants per arm but upon receipt of R01 funding the funds for this pilot study had to be forfeited. Therefore, only 7 were enrolled and completed. Data collection and analyses were limited.

Results Point of Contact

Title
Windy Alonso
Organization
University of Nebraska Medical Center
windy.alonso@unmc.edu
814-577-2941

Study Officials

  • Windy W Alonso, PhD, RN

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

March 28, 2022

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

December 11, 2025

Results First Posted

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)