Using exergaming to help inactive heart failure patients reduce sedentary time
Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study
This study is testing whether a fun video game that gets you moving can help inactive heart failure patients spend less time sitting and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linkoeping University Government |
| Locations | 12 sites (Porto and 11 other locations) |
| Trial ID | NCT05641662 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of tailored exergaming in reducing sedentary time among inactive patients with heart failure. Participants will be randomly assigned to either a control group receiving standard activity advice or an intervention group using the Heart-Exergame, which provides personalized feedback and allows interaction with peers. The study will last for three months, with a focus on improving physical activity levels, exercise capacity, and overall health-related quality of life. The primary outcome will be measured through actigraphy to assess changes in sedentary behavior.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with symptomatic heart failure who are physically inactive and clinically stable.
Not a fit: Patients with significant visual, hearing, or cognitive impairments that prevent them from using exergames may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the physical activity levels and quality of life for patients with heart failure.
How similar studies have performed: Previous studies have shown promise in using exergaming for improving physical activity in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included. 2. Clinically stable 3. Physically inactive 4. Older than 18 years, there is no upper age limit, 5. Speak/understand the language of the country where the study is taking place. 6. Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study) Exclusion Criteria: 1. Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist. 2. Not being able to perform the 6-minute walk test. 3. Not being able or willing to wear an activity monitor. 4. Currently included in a rehabilitation program 5. Lack of willingness to play an exergame. 6. Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).
Where this trial is running
Porto and 11 other locations
- Universidade do Porto Faculdade de Medicina — Porto, Portugal (Recruiting)
- P. J. Safarik University — Košice, Slovakia (Recruiting)
- Germans Trias i Pujol Hospital — Barcelona, Spain (Recruiting)
- Hospital de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital del Mar — Barcelona, Spain (Active_not_recruiting)
- Xarxa Assistencial Universitaria — Manresa, Spain (Recruiting)
- Incliva — Valencia, Spain (Recruiting)
- Jönköping Hospital Rydhov — Jönköping, Sweden (Recruiting)
- Kalmar Länssjukhuset — Kalmar, Sweden (Terminated)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Primary Health Care Centers Östergötland — Norrköping, Sweden (Recruiting)
- Vrinnevisjukhuset — Norrköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Tiny Jaarsma, PhD — Linkoeping University
- Study coordinator: Tiny Jaarsma, PhD
- Email: tiny.jaarsma@liu.se
- Phone: +46011363550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.