NCT05568511

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

Completed NA Results posted Last updated 18 March 2026

What this trial tests

NA trial testing App-based exercise program in Exercise Program in 21 participants. Completed in 29 July 2025.

Timeline

29 March 2023

Primary endpoint
29 July 2025

29 July 2025

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	21
Start date	29 March 2023
Primary completion	29 July 2025
Estimated completion	29 July 2025
Sites	1 location across United States

Drugs / interventions tested

• App-based exercise program
• Standard of Care

Conditions studied

• Exercise Program — all drugs for Exercise Program →
• Standard Care Control — all drugs for Standard Care Control →

Sponsor

University of Florida

Who can join

Adults 55 to 105, any sex, with Exercise Program or Standard Care Control. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Exercise Adherence Primary · Baseline to 3 months

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

Group	Value	95% CI
Exercise Intervention	76	± 18.6

Safety (Number of Adverse Events) Primary · Baseline to 3 months

Recording a number of adverse events during the study period.

Group	Value	95% CI
Exercise Intervention	11
Standard Care Control Group	16

30-second Sit-to-Stand Test Secondary · 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.

Group	Value	95% CI
Exercise Intervention	1.14	± 2.91
Standard Care Control Group	-0.88	± 0.99

4-Stage Balance Test Secondary · 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.

Group	Value	95% CI
Exercise Intervention	5.07	± 4.75
Standard Care Control Group	0.01	± 4.38

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until the end of 12-week follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exercise Intervention

Serious: 1/10 (10%)

Deaths: 1/10

Standard Care Control Group

Serious: 1/11 (9%)

Deaths: 0/11

Serious adverse events (2 terms)

Reaction	System	Exercise Intervention	Standard Care Control Group
Hospitalization	Renal and urinary disorders	—	—
Death	General disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Exercise Intervention	Standard Care Control Group
Musculoskeletal pain or associated issues	Musculoskeletal and connective tissue disorders	—	—
Urinary tract or kidney associated issues	Renal and urinary disorders	—	—
Fatigue/malaise/dizziness/nausea	General disorders	—	—
Respiratory issues	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac issues	Cardiac disorders	—	—
Eye disorders	Eye disorders	—	—
Infections (non-UTI/respiratory)	Infections and infestations	—	—
Falls or injuries	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Hospitalization, Death.

Data from ClinicalTrials.gov NCT05568511 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial.
   Zeidan RS, Ohama MK, Evripidou N, Anton SD, et al · · 2024 · cited 1× · PMID 39418096 · DOI 10.2196/60270
2. Feasibility of home-based, remotely delivered exercise training to improve physical function in older sepsis survivors: a pilot randomized controlled trial.
   Lin Y, Zeidan RS, Ghaderpanah R, Ohama MK, et al · · 2026 · PMID 42168725 · DOI 10.1007/s11357-026-02328-2