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Completed

NCT Number: NCT05568511

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.

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Key information

Age range

55 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App-based exercise program

Other

Remotely-controlled, app-guided exercise program

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.

Primary outcomes

  1. Exercise Adherence

    Time frame: Baseline to 3 months

    Assessment of adherence to exercise intervention - percentage of performed exercise sessions.

  2. Safety (Number of Adverse Events)

    Time frame: Baseline to 3 months

    Recording a number of adverse events during the study period.

Secondary outcomes

  1. 30-second Sit-to-Stand Test

    Time frame: Change between Baseline and 3 months

    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.

  2. 4-Stage Balance Test

    Time frame: Change between Baseline and 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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