Trial results for the Heart Up! program, aimed at reducing hopelessness and improving physical activity in adults with heart disease, were posted on ClinicalTrials.gov on 2026-02-13, involving 224 participants.
Background
Heart disease, after a 30-year decline, is projected to increase by up to 18% by 2030. Despite the prevalence, participation rates in cardiac rehabilitation programs remain very low. Individuals experiencing hopelessness are noted to be less likely to engage in such programs. Hopelessness itself is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease. This study, which included COVID-19 considerations, sought to evaluate the effectiveness of the Heart Up! program in increasing physical activity and reducing hopelessness among patients with heart disease, aiming to advance patient care and outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 224 participants to investigate conditions including Ischemic Heart Disease, Hopelessness, Physical Activity, Motivation, and Social Support. The trial examined the impact of motivational social support (MSS) interventions. Participants were assigned to one of three groups: MSS from a nurse alone (individual participants), MSS from a nurse with additional significant other support (SOS) (dyads), or an attention control (AC) group (individual participants). The primary outcomes for this trial were not explicitly listed in the posted data.
Key results
The trial reported several key measurements across the intervention and control groups:
- Minutes/Day of Physical Activity (Measured by Actigraph):
- Motivational Social Support (MSS) From a Nurse Alone (Individual Participants): mean 6.7 minutes/day (Standard Deviation 8.1)
- MSS From Nurse With Additional Significant Other Support (SOS) (Dyads): mean 4.8 minutes/day (Standard Deviation 5.4)
- Attention Control (AC) (Individual Participants): mean 8.6 minutes/day (Standard Deviation 12.0)
- State Hopelessness (Measured by State-Trait Hopelessness Scale):
- Motivational Social Support (MSS) From a Nurse Alone: mean 1.68 units on a scale (Standard Deviation 0.46)
- MSS From Nurse With Additional Significant Other Support (SOS): mean 1.72 units on a scale (Standard Deviation 0.52)
- Attention Control (AC): mean 1.74 units on a scale (Standard Deviation 0.42)
- Exercise Self-Regulation Questionnaire:
- Motivational Social Support (MSS) From a Nurse Alone: mean 4.45 units on a scale (Standard Deviation 1.09)
- MSS From Nurse With Additional Significant Other Support (SOS): mean 4.82 units on a scale (Standard Deviation 1.05)
- Attention Control (AC): mean 4.86 units on a scale (Standard Deviation 1.28)
- ENRICHD Social Support Inventory:
- Motivational Social Support (MSS) From a Nurse Alone: mean 22.11 score on a scale (Standard Deviation 3.18)
- MSS From Nurse With Additional Significant Other Support (SOS): mean 22.86 score on a scale (Standard Deviation 4.48)
- Attention Control (AC): mean 22.64 score on a scale (Standard Deviation 2.82)
What this means
The posted results indicate that the motivational social support interventions did not lead to an increase in physical activity compared to the attention control group, which showed the highest mean physical activity. However, both intervention groups demonstrated slightly lower mean scores for state hopelessness compared to the attention control group, suggesting a potential, albeit modest, reduction in hopelessness. Measurements for exercise self-regulation and social support did not consistently show higher scores in the intervention groups. Without further statistical analysis, definitive conclusions regarding the efficacy of the Heart Up! program cannot be drawn from these reported measurements alone. The trial's consideration of COVID-19 was part of its design context, but specific outcomes related to the pandemic were not detailed in the results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03907891, titled "Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations", were posted on 2026-02-13 on clinicaltrials.gov.