Exercise ProgramNCT05568511
Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
A study testing App-based exercise program in people with Exercise Program and Standard Care Control, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 105 years
- Conditions the study is for
- Exercise Program, Standard Care Control
- What is being tested?
- App-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 29 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
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.
Read the detailed description
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.
- Conditions
- Exercise Program, Standard Care Control
- Being tested
- App-based exercise program, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based exercise programOther
Remotely-controlled, app-guided exercise program
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based, digitally delivered exercise training program | Experimental | Not described Receives: Other: App-based exercise program |
| Standard care control group | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Adherence
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
Measured: Baseline to 3 months
Safety (Number of Adverse Events)
Recording a number of adverse events during the study period.
Measured: Baseline to 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change between Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start29 Mar 2023
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise ProgramStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Robert Mankowski, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568511
- Sponsor's protocol ID
- IRB202200027 -N-R
- Other IDs
- R21AG075645, OCR42113
- Status last verified
- Aug 2025
- First submitted
- 19 May 2022
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin Y, Zeidan RS, Ghaderpanah R, Ohama MK, Jung MH, Baskaran N, Delgado JS, Anton SD, Smith BK, Leeuwenburgh C, Hsu FC, Efron PA, Buford TW, Flynn S, Guirgis FW, Mankowski RT. Feasibility of home-based, remotely delivered exercise training to improve physical function in older sepsis survivors: a pilot randomized controlled trial. Geroscience. 2026 May 21. doi: 10.1007/s11357-026-02328-2. Online ahead of print.
PubMed 42168725Zeidan RS, Ohama MK, Evripidou N, Anton SD, Hamed LL, Lin Y, Leeuwenburgh C, Guirguis FW, Efron PA, Flynn S, Smith B, Bacher R, Bakarasan N, Sarmiento Delgado J, Mankowski RT. Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 17;13:e60270. doi: 10.2196/60270.
PubMed 39418096