Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial

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.

Study Overview

• Status: Completed
• Conditions: Exercise Program; Standard Care Control
• Intervention / Treatment: Other: App-based exercise program; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • UF Clinical and Translational Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 101 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based, digitally delivered exercise training program	Other: App-based exercise program; Remotely-controlled, app-guided exercise program
Active Comparator: Standard care control group	Other: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Adherence	Assessment of adherence to exercise intervention - percentage of performed exercise sessions.	Baseline to 3 months
Safety (Number of Adverse Events)	Recording a number of adverse events during the study period.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change between Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Robert Mankowski, PhD, University of Florida

Publications and helpful links

General Publications

• Zeidan 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB202200027 -N-R; R21AG075645 (U.S. NIH Grant/Contract); OCR42113 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No