An interventional study of App-based exercise program and Standard of Care in Exercise Program and Standard Care Control, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 55 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
The proposed research will use a multi-disciplinary expertise of the University of Florida Sepsis and Critical Illness Research Center (SCIRC). For this project, the investigators will take advantage of the SCIRC's ongoing recruitment and monitoring of sepsis patients into an observational 1-year follow-up study. For this pilot, the investigators will approach and screen older sepsis survivors who get discharged from hospital to home. Potential participants will be approached within 5 days before discharge. The study will enroll 40 low-functioning (SPPB \<6) older sepsis patients (≥55 years old). The enrolled subjects will be randomized to either digitally delivered and home-based exercise training program or standard care control group. All participants will receive tablets with the Blue Marble Health Platform (BMHP) app. For the control group, the app will be enabled only for the physical function assessments and for the rest of the time, only a health diary for logging daily activities will be available. Both groups will receive weekly phone calls from our research staff member to ask about their health and remind them of weekly charging of their tablets. The intervention group will receive daily reminders by text to perform the exercises for 30 min daily 5 days/week. Participants will be given wrist fitness tracking watches with step-counting and heart rate to measure adherence to an exercise intervention. At baseline and 12-week follow-up visits physical function assessments will be app-guided using the BMHP-validated physical function test similar to SPPB, with a blinded coordinator present via a video call to assist a participant with answering questions about the tests. The interventionists who will be calling the participants will be trained to maintain the same level of rapport to not jeopardize the study conditions.
University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: App-based exercise program
Other: Standard of Care
Remotely-controlled, app-guided exercise program
These participants will follow the usual post-sepsis care after returning to home. The participants will be asked to log their daily activities in the app's health diary. The app will be activated for the baseline and follow-up physical function assessments, which will be supervised be a blinded coordinator via a video call.
Exercise Adherence
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
Time frame: Baseline to 3 months
Safety (Number of Adverse Events)
Recording a number of adverse events during the study period.
Time frame: Baseline to 3 months
30-second Sit-to-Stand Test
Application-guided physical function testing. The 30-second sit-to-stand test assesses lower-body strength and functional mobility by measuring the number of times a participant can rise from a seated position to a full stand and return to sitting within 30 seconds.
Time frame: Change between Baseline and 3 months
4-Stage Balance Test
Application-guided physical function testing. The 4-stage balance test assesses static balance by evaluating a participant's ability to maintain four progressively challenging standing positions for up to 10 seconds each. Successful completion of more advanced stages indicates better balance and postural control.
Time frame: Change between Baseline and 3 months
| Milestone | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| Started | 10 | 11 |
| Completed | 9 | 11 |
| Not completed | 1 | 0 |
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
| Percentage | Exercise Intervention |
|---|---|
| Exercise Adherence | 76 ± 18.6 |
Recording a number of adverse events during the study period.
| number of events | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| Safety (Number of Adverse Events) | 11 | 16 |
Application-guided physical function testing. The 30-second sit-to-stand test assesses lower-body strength and functional mobility by measuring the number of times a participant can rise from a seated position to a full stand and return to sitting within 30 seconds.
| repetitions | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| 30-second Sit-to-Stand Test | 1.14 ± 2.91 | -0.88 ± 0.99 |
Application-guided physical function testing. The 4-stage balance test assesses static balance by evaluating a participant's ability to maintain four progressively challenging standing positions for up to 10 seconds each. Successful completion of more advanced stages indicates better balance and postural control.
| seconds | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| 4-Stage Balance Test | 5.07 ± 4.75 | 0.01 ± 4.38 |
Collected over From enrollment until the end of 12-week follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise Intervention | 1/10 (10%) | 1/10 (10%) | 6/10 (60%) |
| Standard Care Control Group | 0/11 (0%) | 1/11 (9.1%) | 7/11 (63.6%) |
| Event | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| DeathGeneral disorders | 1/10 | 0/11 |
| HospitalizationRenal and urinary disorders | 0/10 | 1/11 |
| Event | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| Musculoskeletal pain or associated issuesMusculoskeletal and connective tissue disorders | 2/10 | 4/11 |
| Fatigue/malaise/dizziness/nauseaGeneral disorders | 2/10 | 0/11 |
| Urinary tract or kidney associated issuesRenal and urinary disorders | 0/10 | 2/11 |
| Respiratory issuesRespiratory, thoracic and mediastinal disorders | 1/10 | 1/11 |
| Cardiac issuesCardiac disorders | 1/10 | 1/11 |
| Infections (non-UTI/respiratory)Infections and infestations | 1/10 | 1/11 |
| Falls or injuriesInjury, poisoning and procedural complications | 1/10 | 1/11 |
| Eye disordersEye disorders | 0/10 | 1/11 |
| Age, Continuous(years old) | Exercise Intervention | Standard Care Control Group | Total |
|---|---|---|---|
| Mean | 69.6 ± 8.5 | 72.3 ± 7.9 | 71 ± 8.1 |
| Sex: Female, Male(Participants) | Exercise Intervention | Standard Care Control Group | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | Exercise Intervention | Standard Care Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Total Sequential Organ Failure Assessment (SOFA) score(scores on a scale) | Exercise Intervention | Standard Care Control Group | Total |
|---|---|---|---|
| Mean | 3.1 ± 0.7 | 2.7 ± 1.1 | 2.9 ± 0.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florida