Trial Outcomes & Findings for Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial (NCT NCT05568511)
NCT ID: NCT05568511
Last Updated: 2026-03-18
Results Overview
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
Exercise Intervention
Home-based, remotely-controlled, app-guided exercise program
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
Baseline characteristics by cohort
| Measure |
Exercise Intervention
n=10 Participants
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=11 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years old
STANDARD_DEVIATION 8.5 • n=110 Participants
|
72.3 years old
STANDARD_DEVIATION 7.9 • n=114 Participants
|
71 years old
STANDARD_DEVIATION 8.1 • n=224 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
9 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=110 Participants
|
9 Participants
n=114 Participants
|
18 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Total Sequential Organ Failure Assessment (SOFA) score
|
3.1 scores on a scale
STANDARD_DEVIATION 0.7 • n=110 Participants
|
2.7 scores on a scale
STANDARD_DEVIATION 1.1 • n=114 Participants
|
2.9 scores on a scale
STANDARD_DEVIATION 0.9 • n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: One participant in the exercise group withdrew from the study; therefore, nine participants were included in the exercise adherence analysis.
Assessment of adherence to exercise intervention - percentage of performed exercise sessions.
Outcome measures
| Measure |
Exercise Intervention
n=9 Participants
Home-based, remotely-controlled, app-guided exercise program
|
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.
|
|---|---|---|
|
Exercise Adherence
|
76 Percentage
Standard Deviation 18.6
|
—
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsRecording a number of adverse events during the study period.
Outcome measures
| Measure |
Exercise Intervention
n=10 Participants
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=11 Participants
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.
|
|---|---|---|
|
Safety (Number of Adverse Events)
|
11 number of events
|
16 number of events
|
SECONDARY outcome
Timeframe: Change between Baseline and 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Exercise Intervention
n=7 Participants
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=8 Participants
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.
|
|---|---|---|
|
30-second Sit-to-Stand Test
|
1.14 repetitions
Standard Deviation 2.91
|
-0.88 repetitions
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Change between Baseline and 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Exercise Intervention
n=7 Participants
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=8 Participants
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
|
5.07 seconds
Standard Deviation 4.75
|
0.01 seconds
Standard Deviation 4.38
|
Adverse Events
Exercise Intervention
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Standard Care Control Group
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise Intervention
n=10 participants at risk
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=11 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Hospitalization
|
0.00%
0/10 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
|
General disorders
Death
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
0.00%
0/11 • From enrollment until the end of 12-week follow-up
|
Other adverse events
| Measure |
Exercise Intervention
n=10 participants at risk
Home-based, remotely-controlled, app-guided exercise program
|
Standard Care Control Group
n=11 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain or associated issues
|
20.0%
2/10 • Number of events 3 • From enrollment until the end of 12-week follow-up
|
36.4%
4/11 • Number of events 7 • From enrollment until the end of 12-week follow-up
|
|
Renal and urinary disorders
Urinary tract or kidney associated issues
|
0.00%
0/10 • From enrollment until the end of 12-week follow-up
|
18.2%
2/11 • Number of events 2 • From enrollment until the end of 12-week follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issues
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
|
Cardiac disorders
Cardiac issues
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 2 • From enrollment until the end of 12-week follow-up
|
|
Eye disorders
Eye disorders
|
0.00%
0/10 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
|
Infections and infestations
Infections (non-UTI/respiratory)
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
|
Injury, poisoning and procedural complications
Falls or injuries
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
9.1%
1/11 • Number of events 1 • From enrollment until the end of 12-week follow-up
|
|
General disorders
Fatigue/malaise/dizziness/nausea
|
20.0%
2/10 • Number of events 3 • From enrollment until the end of 12-week follow-up
|
0.00%
0/11 • From enrollment until the end of 12-week follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place