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

NCT05568511 | Completed Results DMC

• 3 other identifiers: IRB202200027 -N-RR21AG075645OCR42113
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Standard Care Control; Exercise Program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 30-second Sit-to-Stand Test

  Change between Baseline and 3 months

• 4-Stage Balance Test

  Change between Baseline and 3 months

Study Arms (2)

Home-based, digitally delivered exercise training program

EXPERIMENTAL

Other: App-based exercise program

Standard care control group

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

App-based exercise program OTHER

Remotely-controlled, app-guided exercise program

Home-based, digitally delivered exercise training 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.

Standard care control group

Eligibility Criteria

• Age: 55 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UF Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• 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.

  PMID: 39418096 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Robert Mankowski
• Organization: University of Alabama at Birmingham

rmankowski@uabmc.edu

205-996-3006

Study Officials

• Robert Mankowski, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: October 5, 2022
• Study Start: March 29, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)