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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG075645 | U.S. NIH Grant/Contract | View source | |
| OCR42113 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based, digitally delivered exercise training program | Experimental |
| |
| Standard care control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based exercise program | Other | Remotely-controlled, app-guided exercise program |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Mankowski, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Clinical and Translational Research Building | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42168725 | Derived | 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. | |
| 39418096 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Intervention | Home-based, remotely-controlled, app-guided exercise program |
| FG001 | Standard Care Control Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Intervention | Home-based, remotely-controlled, app-guided exercise program |
| BG001 | Standard Care Control Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Adherence | Assessment of adherence to exercise intervention - percentage of performed exercise sessions. | One participant in the exercise group withdrew from the study; therefore, nine participants were included in the exercise adherence analysis. | Posted | Mean | Standard Deviation | Percentage | Baseline to 3 months |
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From enrollment until the end of 12-week follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Intervention | Home-based, remotely-controlled, app-guided exercise program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain or associated issues | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Mankowski | University of Alabama at Birmingham | 205-996-3006 | rmankowski@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2024 | Jan 28, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2025 | Feb 23, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2025 | Aug 11, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | 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. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years old |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Sequential Organ Failure Assessment (SOFA) score | The Sequential Organ Failure Assessment (SOFA) score is a clinical scale used to assess the extent of organ dysfunction across six systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal function. Each subscale is scored from 0 to 4, with higher scores indicating greater dysfunction (worse outcome), and lower scores indicating better organ function. Subscale scores are summed to generate a total SOFA score ranging from 0 to 24, where higher total scores reflect more severe organ failure and poorer clinical outcomes. | Mean | Standard Deviation | scores on a scale |
|
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| Primary | Safety (Number of Adverse Events) | Recording a number of adverse events during the study period. | Posted | Number | number of events | Baseline to 3 months |
|
|
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| Secondary | 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. | Five participants (Exercise: n=2; Control: n=3) were excluded because of inability to complete the physical function assessments due to hospital readmission before the 12-week visit or health status changes that prevented them from performing the tests according to the standard protocol. | Posted | Mean | Standard Deviation | repetitions | Change between Baseline and 3 months |
|
|
|
| Secondary | 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. | Five participants (Exercise: n=2; Control: n=3) were excluded because of inability to complete the physical function assessments due to hospital readmission before the 12-week visit or health status changes that prevented them from performing the tests according to the standard protocol. | Posted | Mean | Standard Deviation | seconds | Change between Baseline and 3 months |
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| 1 |
| 10 |
| 1 |
| 10 |
| 6 |
| 10 |
| EG001 | Standard Care Control Group | 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. | 0 | 11 | 1 | 11 | 7 | 11 |
| Death | General disorders | Non-systematic Assessment |
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| Urinary tract or kidney associated issues | Renal and urinary disorders | Non-systematic Assessment |
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| Respiratory issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cardiac issues | Cardiac disorders | Non-systematic Assessment |
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| Eye disorders | Eye disorders | Non-systematic Assessment |
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| Infections (non-UTI/respiratory) | Infections and infestations | Non-systematic Assessment |
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| Falls or injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Fatigue/malaise/dizziness/nausea | General disorders | Non-systematic Assessment |
|
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