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HEART Camp Connect: Promoting Adherence to Exercise in Adults with Heart Failure with Preserved Ejection Fraction

Award Number: R01HL163288
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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HEART Camp Connect: Promoting Adherence to Exercise in Adults with Heart Failure with Preserved Ejection Fraction - PROJECT SUMMARY/ABSTRACT Heart failure with preserved ejection fraction (HFpEF) is one of the greatest treatment challenges in cardiovascular care today. Exercise is one of few treatments shown to benefit adults with HFpEF. Yet, to achieve and sustain the benefits of exercise, adherence is required. Recent National Heart Lung and Blood Institute (NHLBI) working groups on HFpEF and exercise in heart failure highlighted high priority areas for future study including examining strategies and interventions to promote exercise initiation and adherence, testing interventional mechanisms to improve adherence to exercise, identifying clinically meaningful outcomes for heart failure trials beyond mortality, and examining longitudinal changes in inflammatory biomarkers to better understand correlates to clinical status. Our team has successfully tested an intervention [Heart Failure Exercise and Resistance Training (HEART) Camp] that significantly improves long-term adherence to moderate intensity exercise (≥120 minutes of exercise at a heart rate reserve of 40-80%) in stable, chronic heart failure. Adherence was moderated by ejection fraction and a secondary analysis of our HFpEF subgroup showed promising long- term exercise adherence. We now propose a sufficiently powered randomized controlled trial to test the efficacy of 2 interventions in achieving long-term exercise adherence in adults with HFpEF. Our overall objectives align with NHLBI priorities and work toward achieving our long-term goal to promote adherence to exercise in HFpEF: (a) evaluate the effects of theory-based training and coaching interventions on long-term adherence to exercise, (b) identify minutes of moderate-intensity exercise that relate to clinically meaningful change in patient-reported outcomes, (c) evaluate interventional mechanisms and interim clinical events as mediators of adherence behaviors, and (d) examine the cost of intervention delivery. To meet these objectives, we propose a 3-group randomized controlled trial to compare 2 interventions, HEART Camp (in-person) to HEART Camp Connect (virtual) to each other and to enhanced usual care in adults with HFpEF. The proposed study incorporates several innovations: 1. We are the first to: test the effects of behavioral interventions designed to promote long-term exercise adherence in HFpEF using an objective measure of adherence, attempt to define a benchmark of minutes of exercise needed to achieve a clinically meaningful change, and assess exercise intervention cost; and 2. We incorporate technical innovations including a web application for real-time capture of exercise data, an innovative analytic approach that examines the influence of interim clinical events on adherence, a HFpEF algorithm and large-scale inflammatory assays. These innovations challenge the current paradigm and help to reach new horizons in HFpEF science. Our approach, which combines well-studied theoretical mechanisms delivered with virtual coaching and training tested against in-person coaching and training, will allow us to better understand exercise adherence in HFpEF. This study will have a critical impact by lessening non-adherence as a barrier to progress in the clinical care of adults with HFpEF through regular exercise training.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $658,359 )
2026	2026	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Cardiovascular Diseases Research	001	4	4/24/2026	NON-COMPETING CONTINUATION	$658,359
2026	2025	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Cardiovascular Diseases Research	000	3	4/3/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $658,359

Issue Date FY: 2025 ( Subtotal = $672,027 )
2025	2025	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Cardiovascular Diseases Research	001	3	6/4/2025	NON-COMPETING CONTINUATION	$67,201
2025	2025	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Cardiovascular Diseases Research	000	3	4/25/2025	NON-COMPETING CONTINUATION	$604,826
														Subtotal = $672,027

Issue Date FY: 2024 ( Subtotal = $667,789 )
2024	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	001	2	6/24/2024	NON-COMPETING CONTINUATION	$54,514
2024	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	2	3/29/2024	NON-COMPETING CONTINUATION	$613,275
														Subtotal = $667,789

Issue Date FY: 2023 ( Subtotal = $702,652 )
2023	2023	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Cardiovascular Diseases Research	000	1	4/15/2023	NEW	$702,652
														Subtotal = $702,652

Grand Total All Awards = $2,700,827

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HEART Camp Connect: Promoting Adherence to Exercise in Adults with Heart Failure with Preserved Ejection Fraction

Award Number: R01HL163288

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/15/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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