Home-based exercise program for older sepsis survivors
Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
This study is testing if a home-based exercise program using a tablet can help older people who survived sepsis get stronger and improve their physical function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 55 Years to 105 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05568511 on ClinicalTrials.gov |
What this trial studies
This study aims to improve physical function in older survivors of sepsis through a home-based digital exercise training program. Participants aged 55 and older, who are discharged from the hospital after surviving sepsis, will be randomly assigned to either an exercise intervention group or a standard care control group. The intervention group will receive a tablet with an app for exercise guidance and reminders, while the control group will have limited app functionality. Both groups will receive regular phone calls from research staff to monitor health and adherence. The effectiveness of the program will be assessed through physical function evaluations at baseline and after 12 weeks.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55 and above who have survived sepsis and have low physical function as indicated by an SPPB score of 6 or less.
Not a fit: Patients who are unable to perform lower or upper-body exercises, such as those in a wheelchair or with severe cognitive impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the physical recovery and quality of life for older sepsis survivors.
How similar studies have performed: Other studies have shown promise in using digital interventions for rehabilitation, suggesting that this approach could be effective for similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to perform lower and upper-body movements * Sepsis survivor * Age 55 years and older * SPPB ≤ 6 * Being discharged to home from the hospital after surviving sepsis * Willingness to be randomized to either treatment or control group * Willingness to participate in all study procedures * Willingness to use the devices and technology in the study Exclusion Criteria: * Failure to provide informed consent * Pregnant * Discharge to a long-term facility * Involvement in a structured rehabilitation program * Inability to perform lower or upper-body exercises (e.g. being in wheelchair) * Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina * Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score \< 24 * Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis * Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen * Simultaneous participation in another intervention trial * Poor or no cellular internet service at the primary place of living.
Where this trial is running
Gainesville, Florida
- UF Clinical and Translational Research Building — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Robert Mankowski, PhD — University of Florida
- Study coordinator: Yi Lin
- Email: yi.lin@ufl.edu
- Phone: (205) 996-5876
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.