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

Sponsor

University of Nebraska (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05784753

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HFpEF - Heart Failure With Preserved Ejection Fraction	Behavioral: HEART Camp Behavioral: HEART Camp Connect	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized following a 2-2-1 (HEART Camp Connect - HEART Camp - Enhanced Usual Care) scheme to fully examine comparative effects between virtual and in-person treatment groups.Participants will be randomized following a 2-2-1 (HEART Camp Connect - HEART Camp - Enhanced Usual Care) scheme to fully examine comparative effects between virtual and in-person treatment groups.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Blinded study personnel will participate in all data collection time points, meeting with participants at four time points during the study and confirming completeness of questionnaires.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Apr 1, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Exercise Adherence [6 months]
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a Polar watch and heart rate sensor.
Exercise Adherence [12 months]
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a Polar watch and heart rate sensor.
Exercise Adherence [18 months]
Adherence is measured as weekly minutes of moderate intensity exercise as measured by a Polar watch and heart rate sensor.

Secondary Outcome Measures

HF-related Health Status [Baseline]
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.
HF-related Health Status [6 months]
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.
HF-related Health Status [12 months]
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.
HF-related Health Status [18 months]
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.
Physical Function [Baseline]
Physical function will be measured by distance in meters completed on the 6 minute walk test.
Physical Function [6 months]
Physical function will be measured by distance in meters completed on the 6 minute walk test.
Physical Function [12 months]
Physical function will be measured by distance in meters completed on the 6 minute walk test.
Physical Function [18 months]
Physical function will be measured by distance in meters completed on the 6 minute walk test.
Physical Activity [Baseline, 6, 12, and 18 months]
Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.
Dyspnea Severity [Baseline, 6, 12, and 18 months]
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.
Global Symptoms [Baseline, 6, 12, and 18 months]
PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity
Health-related Quality of Life [Baseline, 6, 12, and 18 months]
Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analog scale
Health Status [Baseline]
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
Health Status [6 months]
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
Health Status [12 months]
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
Health Status [18 months]
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
C-reactive protein (CRP) [Baseline]
CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600
C-reactive protein [12 months]
CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600
Interleukin 1-Beta (IL1-beta) [Baseline]
IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375
Interleukin 1-Beta [12 months]
IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375
Interleukin 1-Alpha (IL1-alpha) [Baseline]
IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278
Interleukin 1-Alpha [12 months]
IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278
Tumor Necrosis Factor-alpha (TNF-alpha) [Baseline]
TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248
Tumor Necrosis Factor-alpha [12 months]
TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248
Tumor Necrosis Factor-beta [Baseline]
TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458
Tumor Necrosis Factor-beta [12 months]
TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458

Other Outcome Measures

Self-Efficacy [Baseline, 6, 12, and 18 months]
Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior
Outcome Expectations [Baseline, 6, 12, and 18 months]
Multi-Dimensional Outcome Expectation for Exercise
Attitudes toward exercise [Baseline, 6, 12, and 18 months]
Attitudes Toward Physical Activity/Exercise Scale
Self-Regulation [Baseline, 6, 12, and 18 months]
Physical Activity Self-Regulation Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Windy Alonso, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT05784753

Other Study ID Numbers:

0040-23-FB

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Windy Alonso, Assistant Professor, University of Nebraska

exercise training

patient adherence

coaching

Additional relevant MeSH terms:

Heart Failure

8-chloro-cyclic adenosine monophosphate

Study Results

No Results Posted as of Mar 27, 2023