HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction

HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction

The goal of this clinical trial is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by videoconference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.

Study Overview

• Status: Recruiting
• Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Behavioral: HEART Camp; Behavioral: HEART Camp Connect

Detailed Description

The overall objectives for this study are to: (a) test the efficacy of virtual and in-person exercise interventions to promote long-term adherence to exercise; (b) determine a benchmark of exercise minutes that reaches a minimal clinically important difference in heart failure related health status and drives improvements in physical function, inflammatory markers, and patient-reported outcomes; (c) identify interventional mechanisms, interim clinical events and prognostic indicators of heart failure with preserved ejection fraction (HFpEF) that mediate adherence; (d) assess delivery method and related cost of the intervention to support translation and scalability. To meet these objectives, investigators propose a three-group, 2-2-1 randomized repeated measures experimental design with 4 data collection points [baseline, 6, 12, and 18 months to compare HEART Camp, HEART Camp Connect, and virtual enhanced usual care (EUC).

This study begins with the cardiopulmonary exercise testing (CPET) . The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise. Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test. Any participants who exhibit potential safety concerns during CPET (e.g. cardiac arrhythmias, balance instability) will be evaluated by a trained providers, prior to continuing in the study. Those deemed unsafe to exercise will be withdrawn. After the CPET, participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation. All participants will be oriented during a one-time in-person training to familiarize them with the 1) Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel; 2) All monitoring devices (Polar watch and Polar heart rate monitor, Actigraph, rating of perceived exertion scale, and exercise diary); and 3) Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content. Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use.

After randomization, participants in the intervention groups (HEART Camp Connect and HEART Camp) meet with a coach for the first 12 months of the study. The HEART Camp group will meet in-person at the medical fitness center with their coach. The HEART Camp Connect group will meet virtually, over videoconference. To improve the scalability of this intervention, investigators will taper coaching sessions according to the following schedule: Months 1-3 weekly, 1-on-1 coaching for 30 minutes; Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week. On alternate weeks, participants will attend a 1-hour group-based exercise training and coaching. During these sessions, the coach will meet with 4-6 participants at once. One half of the class will be an exercise training session and the other half will be a question/answer session for participants to talk to the coach and each other about strategies for exercise. After 12 months, coaching (both intervention groups) and motivational messages (HEART Camp Connect only) will stop and participants will be expected to self-regulate exercise in months 13-18.

Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly. During exercise sessions, participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary.

Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test. At these data collection time points, participants will also wear an activity monitor for 7 days/nights and complete surveys related to their heart failure and exercise.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Windy W Alonso, PhD; Phone Number: 402-559-8342; Email: windy.alonso@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5330
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Windy W Alonso, PhD, RN; Phone Number: 402-559-8342; Email: windy.alonso@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosis of heart failure with an ejection fraction greater than or equal to 50
• Echocardiogram in prior 24 months
• Stable pharmacologic therapy in the past 30 days
• Score greater than or equal to 6 on the heart failure with preserved ejection fraction algorithm or hemodynamic evidence of HFpEF

Exclusion Criteria:

• Life-limiting illness precluding study completion
• Clinical evidence of decompensated heart failure
• Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
• Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
• Orthopedic or neuromuscular disorders preventing aerobic exercise
• Cardiopulmonary exercise test results that preclude safe exercise
• Unwilling/unable to complete pre-randomization procedures
• Pregnancy
• Implantable cardioverter defibrillator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEART Camp; Participants in the HEART Camp group will be provided paid, in-person access to the medical fitness center and in-person coaching by a trained coach.	Behavioral: HEART Camp; Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).
Experimental: HEART Camp Connect; Participants in the HEART Camp Connect group will be provided paid, virtual access to the medical fitness center and virtual coaching by a trained coach via videoconference. Participants will also receive automated, asynchronous motivational electronic messaging if they are below the weekly adherence threshold.	Behavioral: HEART Camp Connect; Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).
No Intervention: Enhanced Usual Care; Participants in the Enhanced Usual Care group will be provided paid virtual access to the medical fitness center and virtual availability of the medical fitness center staff and study personnel for participant-initiated questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Adherence	Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.	6 months
Exercise Adherence	Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.	12 months
Exercise Adherence	Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Physical function will be measured by distance in meters completed on the 6 minute walk test.	Baseline
Physical Function	Physical function will be measured by distance in meters completed on the 6 minute walk test.	6 months
Physical Function	Physical function will be measured by distance in meters completed on the 6 minute walk test.	12 months
Physical Function	Physical function will be measured by distance in meters completed on the 6 minute walk test.	18 months
Health Status	Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state	Baseline
Health Status	Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state	6 months
Health Status	Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state	12 months
Health Status	Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state	18 months
C-reactive protein (CRP)	CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600	Baseline
C-reactive protein	CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600	12 months
Interleukin 1-Beta (IL1-beta)	IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375	Baseline
Interleukin 1-Beta	IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375	12 months
Interleukin 1-Alpha (IL1-alpha)	IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278	Baseline
Interleukin 1-Alpha	IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278	12 months
Tumor Necrosis Factor-alpha (TNF-alpha)	TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248	Baseline
Tumor Necrosis Factor-alpha	TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248	12 months
Tumor Necrosis Factor-beta	TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458	Baseline
Tumor Necrosis Factor-beta	TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458	12 months
HF-related Health Status	Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.	Baseline
HF-related Health Status	Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.	6 months
HF-related Health Status	Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.	12 months
HF-related Health Status	Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.	18 months
Physical Activity	Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.	Baseline
Physical Activity	Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.	6 months
Physical Activity	Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.	12 months
Physical Activity	Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.	18 months
Dyspnea Severity	Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.	Baseline
Dyspnea Severity	Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.	6 months
Dyspnea Severity	Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.	12 months
Dyspnea Severity	Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.	18 months
Global Symptoms	PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.	Baseline
Global Symptoms	PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.	6 months
Global Symptoms	PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.	12 months
Global Symptoms	PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.	18 months
Health-related Quality of Life	Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.	Baseline
Health-related Quality of Life	Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.	6 months
Health-related Quality of Life	Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.	12 months
Health-related Quality of Life	Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy	Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.	Baseline
Self-Efficacy	Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.	6 months
Self-Efficacy	Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.	12 months
Self-Efficacy	Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.	18 months
Outcome Expectations	Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.	Baseline
Outcome Expectations	Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.	6 months
Outcome Expectations	Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.	12 months
Outcome Expectations	Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.	18 months
Attitudes toward exercise	Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.	Baseline
Attitudes toward exercise	Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.	6 months
Attitudes toward exercise	Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.	12 months
Attitudes toward exercise	Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.	18 months
Self-Regulation	Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.	Baseline
Self-Regulation	Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.	6 months
Self-Regulation	Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.	12 months
Self-Regulation	Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.	18 months
Informational Support	PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.	Baseline
Informational Support	PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.	6 months
Informational Support	PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.	12 months
Informational Support	PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.	18 months
Instrumental Support	PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.	Baseline
Instrumental Support	PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.	6 months
Instrumental Support	PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.	12 months
Instrumental Support	PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.	18 months
Social Isolation	PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.	Baseline
Social Isolation	PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.	6 months
Social Isolation	PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.	12 months
Social Isolation	PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.	18 months
Emotional Support	PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.	Baseline
Emotional Support	PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.	6 months
Emotional Support	PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.	12 months
Emotional Support	PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.	18 months
Types of Physical Activity	International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.	Baseline
Types of Physical Activity	International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.	6 months
Types of Physical Activity	International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.	12 months
Types of Physical Activity	International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.	18 months
Fatigue	Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.	Baseline
Fatigue	Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.	6 months
Fatigue	Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.	12 months
Fatigue	Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.	18 months
Cognitive Assessment	Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.	Baseline
Cognitive Assessment	Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.	6 months
Cognitive Assessment	Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.	12 months
Cognitive Assessment	Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.	18 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Windy W Alonso, PhD, University of Nebraska

Publications and helpful links

General Publications

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available. Erratum In: Eur Heart J. 2013 Jan;34(2):158.
• Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
• Fleg JL, Cooper LS, Borlaug BA, Haykowsky MJ, Kraus WE, Levine BD, Pfeffer MA, Pina IL, Poole DC, Reeves GR, Whellan DJ, Kitzman DW; National Heart, Lung, and Blood Institute Working Group. Exercise training as therapy for heart failure: current status and future directions. Circ Heart Fail. 2015 Jan;8(1):209-20. doi: 10.1161/CIRCHEARTFAILURE.113.001420. No abstract available.
• Shah SJ, Borlaug BA, Kitzman DW, McCulloch AD, Blaxall BC, Agarwal R, Chirinos JA, Collins S, Deo RC, Gladwin MT, Granzier H, Hummel SL, Kass DA, Redfield MM, Sam F, Wang TJ, Desvigne-Nickens P, Adhikari BB. Research Priorities for Heart Failure With Preserved Ejection Fraction: National Heart, Lung, and Blood Institute Working Group Summary. Circulation. 2020 Mar 24;141(12):1001-1026. doi: 10.1161/CIRCULATIONAHA.119.041886. Epub 2020 Mar 23.
• Pandey A, Parashar A, Kumbhani D, Agarwal S, Garg J, Kitzman D, Levine B, Drazner M, Berry J. Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials. Circ Heart Fail. 2015 Jan;8(1):33-40. doi: 10.1161/CIRCHEARTFAILURE.114.001615. Epub 2014 Nov 16.
• Pozehl BJ, Duncan K, Hertzog M, McGuire R, Norman JF, Artinian NT, Keteyian SJ. Study of adherence to exercise in heart failure: the HEART camp trial protocol. BMC Cardiovasc Disord. 2014 Nov 29;14:172. doi: 10.1186/1471-2261-14-172.
• Pozehl BJ, McGuire R, Duncan K, Kupzyk K, Norman J, Artinian NT, Deka P, Krueger SK, Saval MA, Keteyian SJ. Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure. J Card Fail. 2018 Oct;24(10):654-660. doi: 10.1016/j.cardfail.2018.06.007. Epub 2018 Aug 16.
• Warehime S, Dinkel D, Alonso W, Pozehl B. Long-term exercise adherence in patients with heart failure: A qualitative study. Heart Lung. 2020 Nov-Dec;49(6):696-701. doi: 10.1016/j.hrtlng.2020.08.016. Epub 2020 Aug 27.
• Alonso WW, Kupzyk K, Norman J, Bills SE, Bosak K, Dunn SL, Deka P, Pozehl B. Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure. Ann Behav Med. 2021 Oct 4;55(10):1031-1041. doi: 10.1093/abm/kaab002.
• Norman JF, Kupzyk KA, Artinian NT, Keteyian SJ, Alonso WS, Bills SE, Pozehl BJ. The influence of the HEART Camp intervention on physical function, health-related quality of life, depression, anxiety and fatigue in patients with heart failure. Eur J Cardiovasc Nurs. 2020 Jan;19(1):64-73. doi: 10.1177/1474515119867444. Epub 2019 Aug 2.
• Keteyian SJ. Exercise training in congestive heart failure: risks and benefits. Prog Cardiovasc Dis. 2011 May-Jun;53(6):419-28. doi: 10.1016/j.pcad.2011.02.005.
• Pozehl BJ, Mcguire R, Duncan K, Hertzog M, Deka P, Norman J, Artinian NT, Saval MA, Keteyian SJ. Accelerometer-Measured Daily Activity Levels and Related Factors in Patients With Heart Failure. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):329-335. doi: 10.1097/JCN.0000000000000464.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: exercise training; patient adherence; coaching
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; 8-chloro-cyclic adenosine monophosphate
• Other Study ID Numbers: 0040-23-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available in the NHLBI Data Repository under the standard procedures utilized by NHLBI to allow others access to the data. All data from baseline, months 6, 12 and 18 will be provided. Procedural-based data such as the cardiopulmonary exercise test results and the heart rate monitor data will also be provided.
• IPD Sharing Time Frame: Data will be available beginning 9 months after the publication of primary outcome results.
• IPD Sharing Access Criteria: Researchers that desire access to data from this study will be required to provide a methodologically sound proposal and comply with the standards outlined in the NHLBI data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No