Digital Exercise Program for Sepsis Survivors

Overseen By Yi Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Steroid pills, injections

Disqualifiers: Severe cardiac, cognitive, pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment App-based exercise program for sepsis survivors?

Research shows that exercise programs, like a music-guided exercise intervention, can improve muscle strength in ICU survivors, which suggests that similar digital exercise programs might help sepsis survivors regain strength and prevent further health decline. ^{1 2 3 4 5}

Is the digital exercise program safe for sepsis survivors?

Exercise-based rehabilitation, including digital programs, is generally considered safe for sepsis survivors and can help improve physical function and quality of life. However, the overall quality of evidence is low, and more research is needed to confirm these findings. ^{1 4 6 7 8}

How does the digital exercise program for sepsis survivors differ from other treatments?

The digital exercise program for sepsis survivors is unique because it uses an app-based approach to facilitate exercise, making it more accessible and potentially more engaging for patients compared to traditional physical therapy. This method leverages technology to provide structured exercise guidance, which can be done at home, offering a novel way to support recovery and improve physical activity levels in sepsis survivors. ^{3 4 5 9 10}

Research Team

Robert Mankowski, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for older adults, aged 55 and above, who have survived sepsis and are being discharged home from the hospital. They should be able to do basic body movements but have a low physical function score (SPPB ≤ 6). Participants must be willing to use technology for the study and agree to be randomly assigned to either the exercise program or standard care.

Inclusion Criteria

Sepsis survivor

I am willing to be assigned to any treatment group in the study.

My physical abilities are significantly limited.

Exclusion Criteria

Failure to provide informed consent

I do not have severe heart problems like bad heart failure or uncontrolled chest pain.

I need steroids or extra oxygen for my severe lung condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants are randomized to either a digitally delivered home-based exercise training program or standard care control group

12 weeks

Weekly phone calls, daily text reminders for exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• App-based exercise program
• Standard of Care

Trial Overview The HEAL Sepsis Trial is testing if a home-based digital exercise program can improve physical function in older sepsis survivors compared with those receiving standard post-sepsis care. The exercise routine is delivered through an app, aiming at convenient access for participants.

Participant Groups

Group I: Home-based, digitally delivered exercise training program Experimental Treatment 1 Intervention

Group II: Standard care control group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Mice that engaged in low-intensity exercise during the acute phase of sepsis showed higher survival rates compared to sedentary mice, indicating that exercise may have a protective effect during sepsis.

Exercise increased fatty acid oxidation and levels of PGC-1α, a protein associated with energy metabolism, suggesting that physical activity helps mobilize energy sources and may improve outcomes in sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity exercise in the acute phase of lipopolysaccharide-induced sepsis improves lipid metabolism and survival in mice by stimulating PGC-1α expression. Irahara, T., Sato, N., Inoue, K., et al.[2018]

In a pilot study involving 12 critically ill children in a Pediatric Critical Care Unit, virtual reality exercise using Nintendo Wii™ Boxing was found to be safe, with no adverse events reported during the intervention.

While the VR exercise increased upper limb activity compared to daily activity, challenges in feasibility were noted, as only 8 participants completed the study, indicating potential barriers to implementation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. Abdulsatar, F., Walker, RG., Timmons, BW., et al.[2022]

Survivors of severe sepsis and septic shock showed significant physical inactivity during hospitalization, spending 90% of their time lying or sitting, which improved to 58% three months after discharge but still remained lower than healthy individuals.

Muscle strength and exercise capacity in these patients were only about 54% of predicted values at discharge, improving to 70% after three months, indicating a slow recovery process influenced negatively by factors like systemic corticosteroid use and longer hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, muscle strength, and exercise capacity 3 months after severe sepsis and septic shock. Borges, RC., Carvalho, CR., Colombo, AS., et al.[2022]

Inadequate exercise significantly increases the risk of sepsis mortality, with a 2.24-fold higher risk for sepsis as an underlying cause and a 2.11-fold higher risk when sepsis is a contributing factor, based on a study of 155,484 participants over an average of 11.6 years.

The risk associated with inadequate exercise is particularly pronounced in individuals with diabetes, showing a 4.78-fold increase in sepsis mortality risk, highlighting the importance of regular physical activity for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate exercise as a risk factor for sepsis mortality. Williams, PT.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-intensity exercise in the acute phase of lipopolysaccharide-induced sepsis improves lipid metabolism and survival in mice by stimulating PGC-1α expression. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

An observational study investigating the use of patient-owned technology to quantify physical activity in survivors of critical illness. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity, muscle strength, and exercise capacity 3 months after severe sepsis and septic shock. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors-A Pilot Randomized Controlled Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Inadequate exercise as a risk factor for sepsis mortality. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Early rehabilitation to prevent post-intensive care syndrome in critical illness patients: a Meta-analysis]. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review. [2021]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulator as a Protective Treatment against Intensive Care Unit Muscle Wasting in Sepsis/Septic Shock Patients. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Examining the positive effects of exercise in intubated adults in ICU: a prospective repeated measures clinical study. [2022]