N/A
Completed N=224
Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations
Heart Failure · Hopelessness · Physical Activity · Motivation
Source: ClinicalTrials.gov NCT03907891 ↗
Enrolled (actual)
224
Serious AEs
6.3%
Results posted
Feb 2026
Primary outcomePrimary: Minutes/Day of Physical Activity (Measured by Actigraph) — 6.7; 4.8; 8.6 minutes/day
Summary
After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes/Day of Physical Activity (Measured by Actigraph) |
6.7; 4.8; 8.6 | — |
| PRIMARY State Hopelessness (Measured by State-Trait Hopelessness Scale) |
1.68; 1.72; 1.74 | — |
| SECONDARY Exercise Self-Regulation Questionnaire |
4.45; 4.82; 4.86 | — |
| SECONDARY ENRICHD Social Support Inventory |
22.11; 22.86; 22.64 | — |
Eligibility Criteria
Inclusion Criteria
- Adults ≥18 years old
- Diagnosed with MI, unstable angina, who undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery
- Use a cell phone with text messaging
- Receive a recommendation to engage in physical activity either at home or in a hospital-based cardiac rehabilitation setting
- Have a planned discharge home
- Can identify a significant other who can text message them
- Speak and read English
- Can complete the screening instrument
- A score of ≥1.8 on the 10-item state subscale of the State-Trait Hopelessness Scale
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03907891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.