Background
Methods/Design
Ethics approval
Study aims
Research design
Sample size
Subjects
Recruitment and enrollment
Participants
Inclusion criteria | Exclusion criteria |
---|---|
• Diagnosis of heart failure | • Clinical evidence of decompensated HF |
Stage C chronic HF | • Unstable angina pectoris |
Confirmed by echocardiography and clinical evaluation) | • Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker less than 6 weeks prior |
Either Heart Failure preserved Ejection Fraction (HFpEF) or Heart Failure reduced Ejection Fraction (HFrEF) | |
• Nineteen years of age or greater | • Orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training |
• Able to speak and read English | • Participation in 3 times per week aerobic exercise during the previous 8 weeks. |
• Telephone access in home (land line or cell phone) | • Cardiopulmonary stress test results that preclude safe exercise training |
• Stable pharmacologic therapy per guidelines for past 30 days (i.e., stable doses of beta-blocker, ACEI or ARB, diuretic) | • Plans to move more than 50 miles from the exercise site within the next year |
• MVO2 in females >21 ml/kg/min and in males >24 ml/kg/min | |
• Pregnancy - If participant is pregnant or plans to become pregnant during the study |
Baseline exercise testing and training
Intervention
Conceptual framework/background
Intervention components
Intervention component | HEART camp intervention strategies & camp activities | Delivery mode |
---|---|---|
KNOWLEDGE
| ||
Knowledge of exercise training | • Aerobic exercise | 9 exercise training sessions delivered by facility staff. |
• Resistance exercise (bands, free weights or circuit equipment) | ||
• Heart rate monitor to self-monitor | Weekly meetings with coach for training first 12 months. | |
• Rating of perceived exertion (RPE) to self-monitor | ||
Camp topics on exercise in the daily life of a patient with HF | • HEART Camp Motto – “Choose to Move for Heart Improvement” – Discussion of expectations and feelings related to exercise | Weekly group sessions with the RN (30 minutes of content and 30 minutes of discussion). |
• “Game Day: Firing up your Engine” – Pathophysiology of HF and benefits of exercise | ||
• “Telling Your Story” – Sharing symptom experiences and understanding symptoms in relation to exercise | Schedule will repeat every 6 weeks. Subjects expected to attend each session at least once. Subjects encouraged to bring significant others/family to sessions. | |
• “Show & Tell” – Bring medications to group session and discuss actions and effects in relation to exercise | ||
• “Pack-a-Lunch Day” – Dietary sodium and fluid restrictions (discuss fluid retention and effects on exercise) | ||
• “Survival Guide” – How-to exercise safely during life’s ups and downs | ||
ATTITUDES
| ||
Safety (Reducing fear) | • Cardiopulmonary Stress Test (CPX) at beginning of run-in | Facility staff and coach use individual exercise guidelines to adjust exercise |
• Individual exercise guidelines determined from CPX (40%-80% HRR) | ||
Perceived benefits and barriers | • Complete Barriers Self-Efficacy Scale (BARSE) at each data collection point | Weekly meetings with the coach to discuss barriers, strategies to overcome barriers, and reinforce exercise benefits |
• Weekly discussion with coach to identify individual strategies for overcoming perceived barriers to exercise and reinforcement of benefits | ||
SELF-EFFICACY
| ||
Enactive mastery experiences (performance accomplishment) | • Return demonstrate use of exercise equipment and heart rate monitor | Subject’s weekly meeting with coach |
• Goal setting for weekly exercise & review of weekly graphs of goal accomplishment (total number of sessions, total number of minutes of moderate intensity exercise) | ||
Vicarious experience | • Sharing successes during group session discussion | Weekly group sessions with RN allow 30 minutes for group discussion and sharing |
• Sharing strategies to overcome barriers during group sessions | ||
Verbal persuasion | • Education on benefits of exercise | Six weekly group sessions with camp counselor. |
• Web-based educational material related to exercise (HFSA Module on Exercise) | Weekly meetings with coach to discuss goal-setting and feedback. | |
• Feedback related to individual progress toward goals | ||
Physiological & affective States | • Symptom assessment education | Discussed in group sessions and as needed by coach |
• Recognition of warning symptoms to moderate or stop exercise | ||
• Symptom management strategies for exercise | ||
BEHAVIORAL SELF-MANAGEMENT SKILLS
| ||
Goal setting | • Goals: number of sessions and number of minutes of moderate intensity exercise per week | Coach reviews with subject each week |
Self-monitoring | • Return demonstration of self-monitoring techniques (heart rate, rating of perceived exertion, symptoms) | Facility staff and coach |
• Entry/log in exercise diary | Coach reviews diary weekly | |
Problem-solving | • Subject notes problems in exercise diary | Coach reviews diary weekly |
• Subject reviews problems with coach | ||
Barriers management | • Coach reviews BARSE at data collection time points (Baseline, 6 and 12 months) | Coach discusses individual perceptions and strategies |
Relapse management | • Phone call to subject if relapse for one week | Coach places phone call to set up face-to-face meeting |
SOCIAL SUPPORT
| ||
Social relationships | • Six weeks with RN in camp group sessions | Group sessions |
• Weekly interaction with coach during adoption and transition | Weekly coach interaction |
Intervention phases
Phase 1 – adoption (Baseline-6 months)
Phase 2 – transition (Months 7–12)
Phase 3 – maintenance (Months 13–18)
Standard care
Procedures for intervention fidelity
Study outcomes and data collection
Variable | Measure description (data collection time points) |
---|---|
Baseline & screening
| |
Demographic and clinical variables Tool
| Demographic (e.g., race, gender, age, marital status) |
Clinical data (e.g., ejection fraction or EF, medications, BMI, comorbidities) | |
Cardiopulmonary stress test
| Determine suitability for exercise (no significant ischemia or arrhythmias) |
Heart rate ranges and appropriate levels of exercise training | |
Primary outcome – Aim 1 (Baseline, 6, 12 and 18 months)
| |
Adherence
| |
Self-report
|
Exercise diary for self-report of sessions per week and minutes per session [56] |
Heart rate monitor
|
Heart rate monitor (used as validation of self-reported exercise each week |
Evaluation of intervention mechanisms – Aim 2 (Baseline, 6, 12 and 18 months)
| |
Knowledge
|
Physical activity & heart disease I.Q. – developed by NHLBI [57] 12 true/false items testing knowledge of how physical activity affects the heart |
Attitudes
|
Attitudes toward physical activity/exercise - 8 items measure negative attitudes toward physical activity and 6 items measure positive attitudes toward physical activity [58] |
Self-efficacy
|
Barriers Self-Efficacy Scale (BARSE) – 13 item scale measures self-efficacy or confidence in exercise behavior [59]; |
Self-management
|
Physical Activity Self-Regulation Scale (PASR 12)
|
Self-monitoring (2 items), Goal setting (2 items), Eliciting social support (2 items), Reinforcements (2 items), Time management (2 items) and Relapse management (2 items) [60] | |
Social support
|
Revenson Support Scale
|
Problematic support (4 items) and Positive support (16 items) [61] | |
Health outcomes – Aim 3 (Baseline, 6, 12 and 18 months)
| |
Physical function
| |
Psychological function
|
PROMIS-29 Profile v1.0: Anxiety (4 item subscale), Depression (4 item subscale), Satisfaction with Social Role (4 item subscale) [64] |
Symptoms
|
Dyspnea/Fatigue Scale – Measures the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace at which the task is performed, and the associated functional impairment in general activities as a result of the symptoms [65] |
Quality of life
| |
Qualitative data – Aim 5
| |
Open-Ended questions
| All subjects complete at baseline
|
All subjects at baseline
| Survey prior experience with exercise, expectations related to exercise and outcomes from participation |
Open-ended comments on exercise diaries
| All subjects complete each week of the study |
All subjects each week
| What helped you to exercise this week? What made exercising a challenge this week? Other comments? |
One-on-one interviews
| Open-ended questions with probing (30 minutes) |
with HC subjects
| Interviews completed at 3, 6, 12 and 18 months |
Survey subjects’ perceptions of their experience with exercise adherence (e.g., challenges with adherence, helpful strategies, difficulties) | |
One-on-one interviews with coaches
| Open-ended questions with probing (every 6 months during active recruitment) |
Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process for each phase | |
One-on-one interviews with group session leaders
| Open-ended questions with probing (every 6 months during active recruitment) |
Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process |