N/A
Completed N=21
Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
Exercise Program · Standard Care Control
Source: ClinicalTrials.gov NCT05568511 ↗
Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Mar 2026
Primary outcomePrimary: Exercise Adherence — 76 Percentage
Summary
Older sepsis survivors have poor physical function and need post-sepsis physical rehabilitation. Often times, sepsis survivors live far from research facilities and do not have access to rehabilitation services. Remotely delivered exercise intervention could be the key to improve physical function in this population. Therefore, the study proposes to recruit older sepsis survivors at discharge from the hospital to home and assign them to either exercise training or standard care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Adherence |
76 | — |
| PRIMARY Safety (Number of Adverse Events) |
11; 16 | — |
| SECONDARY 30-second Sit-to-Stand Test |
1.14; -0.88 | — |
| SECONDARY 4-Stage Balance Test |
5.07; 0.01 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05568511). 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.