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NCT Number: NCT05784753

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

The goal of this study 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 video conference 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Any of the following evidence to confirm HFpEF - Score< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis 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

Treatment and study plan

HEART Camp

Behavioral

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).

HEART Camp Connect

Behavioral

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).

Primary outcomes

  1. Exercise Adherence

    Time frame: 6 months

    Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

  2. Exercise Adherence

    Time frame: 12 months

    Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

  3. Exercise Adherence

    Time frame: 18 months

    Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

Secondary outcomes

  1. HF-related Health Status

    Time frame: 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. 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.

  2. HF-related Health Status

    Time frame: 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. 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.

  3. HF-related Health Status

    Time frame: 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. 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.

  4. HF-related Health Status

    Time frame: 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. 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.

  5. Physical Function

    Time frame: Baseline

    Physical function will be measured by distance in meters completed on the 6 minute walk test.

  6. Physical Function

    Time frame: 6 months

    Physical function will be measured by distance in meters completed on the 6 minute walk test.

  7. Physical Function

    Time frame: 12 months

    Physical function will be measured by distance in meters completed on the 6 minute walk test.

  8. Physical Function

    Time frame: 18 months

    Physical function will be measured by distance in meters completed on the 6 minute walk test.

  9. Physical Activity

    Time frame: Baseline

    Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

  10. Physical Activity

    Time frame: 6 months

    Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

  11. Physical Activity

    Time frame: 12 months

    Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

  12. Physical Activity

    Time frame: 18 months

    Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

  13. Dyspnea Severity

    Time frame: Baseline

    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.

  14. Dyspnea Severity

    Time frame: 6 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. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

  15. Dyspnea Severity

    Time frame: 12 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. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

  16. Dyspnea Severity

    Time frame: 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. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

  17. Global Symptoms

    Time frame: Baseline

    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. Global Symptoms

    Time frame: 6 months

    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.

  19. Global Symptoms

    Time frame: 12 months

    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.

  20. Global Symptoms

    Time frame: 18 months

    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.

  21. Health-related Quality of Life

    Time frame: Baseline

    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.

  22. Health-related Quality of Life

    Time frame: 6 months

    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.

  23. Health-related Quality of Life

    Time frame: 12 months

    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.

  24. Health-related Quality of Life

    Time frame: 18 months

    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.

  25. Health Status

    Time frame: 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

  26. Health Status

    Time frame: 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

  27. Health Status

    Time frame: 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

  28. Health Status

    Time frame: 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

  29. C-reactive protein (CRP)

    Time frame: Baseline

    CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600

  30. C-reactive protein

    Time frame: 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

  31. Interleukin 1-Beta (IL1-beta)

    Time frame: Baseline

    IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375

  32. Interleukin 1-Beta

    Time frame: 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

  33. Interleukin 1-Alpha (IL1-alpha)

    Time frame: Baseline

    IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278

  34. Interleukin 1-Alpha

    Time frame: 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

  35. Tumor Necrosis Factor-alpha (TNF-alpha)

    Time frame: Baseline

    TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248

  36. Tumor Necrosis Factor-alpha

    Time frame: 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

  37. Tumor Necrosis Factor-beta

    Time frame: Baseline

    TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458

  38. Tumor Necrosis Factor-beta

    Time frame: 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 outcomes

  1. Self-Efficacy

    Time frame: Baseline

    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.

  2. Self-Efficacy

    Time frame: 6 months

    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.

  3. Self-Efficacy

    Time frame: 12 months

    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.

  4. Self-Efficacy

    Time frame: 18 months

    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.

  5. Outcome Expectations

    Time frame: Baseline

    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. Outcome Expectations

    Time frame: 6 months

    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.

  7. Outcome Expectations

    Time frame: 12 months

    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.

  8. Outcome Expectations

    Time frame: 18 months

    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.

  9. Attitudes toward exercise

    Time frame: Baseline

    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.

  10. Attitudes toward exercise

    Time frame: 6 months

    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.

  11. Attitudes toward exercise

    Time frame: 12 months

    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. Attitudes toward exercise

    Time frame: 18 months

    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.

  13. Self-Regulation

    Time frame: Baseline

    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.

  14. Self-Regulation

    Time frame: 6 months

    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.

  15. Self-Regulation

    Time frame: 12 months

    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.

  16. Self-Regulation

    Time frame: 18 months

    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.

  17. Informational Support

    Time frame: Baseline

    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. Informational Support

    Time frame: 6 months

    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.

  19. Informational Support

    Time frame: 12 months

    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.

  20. Informational Support

    Time frame: 18 months

    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.

  21. Instrumental Support

    Time frame: Baseline

    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.

  22. Instrumental Support

    Time frame: 6 months

    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.

  23. Instrumental Support

    Time frame: 12 months

    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.

  24. Instrumental Support

    Time frame: 18 months

    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.

  25. Social Isolation

    Time frame: Baseline

    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.

  26. Social Isolation

    Time frame: 6 months

    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.

  27. Social Isolation

    Time frame: 12 months

    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.

  28. Social Isolation

    Time frame: 18 months

    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.

  29. Emotional Support

    Time frame: Baseline

    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.

  30. Emotional Support

    Time frame: 6 months

    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.

  31. Emotional Support

    Time frame: 12 months

    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.

  32. Emotional Support

    Time frame: 18 months

    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.

  33. Types of Physical Activity

    Time frame: Baseline

    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.

  34. Types of Physical Activity

    Time frame: 6 months

    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.

  35. Types of Physical Activity

    Time frame: 12 months

    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.

  36. Types of Physical Activity

    Time frame: 18 months

    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.

  37. Fatigue

    Time frame: Baseline

    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.

  38. Fatigue

    Time frame: 6 months

    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.

  39. Fatigue

    Time frame: 12 months

    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.

  40. Fatigue

    Time frame: 18 months

    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.

  41. Cognitive Assessment

    Time frame: Baseline

    Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

  42. Cognitive Assessment

    Time frame: 6 months

    Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

  43. Cognitive Assessment

    Time frame: 12 months

    Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

  44. Cognitive Assessment

    Time frame: 18 months

    Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Windy W Alonso, PhD

CONTACT

[email protected]

402-559-8342

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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