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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app-based exercise program designed to help older sepsis survivors regain physical strength after hospital discharge. The researchers aim to determine if home exercise with digital guidance offers benefits over standard care. Participants will be divided into two groups: one using the app for exercise and the other receiving standard care. The trial seeks individuals aged 55 and older who have survived sepsis and can perform basic arm and leg movements. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery options for sepsis survivors.

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 prior data suggests that this app-based exercise program is safe for sepsis survivors?

Research has shown that exercise programs delivered through apps can safely help sepsis survivors improve their physical abilities. One study found these remote exercise programs both safe and effective for this group. Another study examined their safety and practicality, revealing that participants adhered well to the sessions, indicating the program's ease of use. No major negative effects were reported, suggesting the treatment is generally safe for older adults recovering from sepsis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this app-based exercise program for sepsis survivors because it offers a convenient and accessible way to aid recovery right from home. Unlike traditional rehabilitation options that often require visits to a physical therapy clinic, this digital program allows survivors to engage in guided exercises through an app, making it easier to incorporate into daily life. This approach could help improve the quality of life for sepsis survivors by providing flexibility and reducing barriers to access, ultimately supporting better long-term health outcomes.

What evidence suggests that this app-based exercise program is effective for sepsis survivors?

This trial will compare a home-based, digitally delivered exercise training program with standard care for sepsis survivors. Research has shown that an exercise program delivered through an app at home can help older sepsis survivors improve their physical abilities. Studies have found that this type of exercise plan is safe and can greatly enhance movement and strength after sepsis. Specifically, one small study found that a 12-week exercise program done remotely was safe and feasible for middle-aged and older adults recovering from sepsis. This method is promising because it allows patients to perform rehabilitation exercises at home, which benefits those who can't easily access in-person services. Overall, evidence supports that digital exercise programs can significantly aid recovery and improve the quality of life for sepsis survivors. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert Mankowski, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Willingness to participate in all study procedures

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528160/

Protocol of the HEAL Sepsis Randomized Clinical Trial Remotely delivered exercise interventions tailored to this population hold promise to improve physical function safely and effectively after sepsis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05568511

Home-based Digital Exercise Training Program to Improve ... Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial.

3. researchgate.net researchgate.net/publication/396171100_Home-Based_Remotely-Delivered_Exercise_Training_to_Improve_Physical_Function_of_Middle-aged_and_Older_Sepsis_Survivors_-_the_HEAL_Sepsis_Trial_Preprint

the HEAL Sepsis Trial (Preprint) | Request PDF CONCLUSIONS This pilot RCT demonstrated that a 12-week, remotely delivered exercise program was safe and feasible for middle-aged and older ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422001173

An RCT assessing 2 levels of app-based programming in ... The aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12159120/

Home-based online exercise training and chronic, low-grade ... We aimed to investigate whether home-based online exercise training can mitigate chronic, low-grade inflammation of cancer patients after curative oncologic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329728/

Safety, feasibility and initial efficacy of an app-facilitated ... The primary outcome was feasibility, including safety and session adherence. Secondary outcomes included preliminary efficacy outcomes including tests of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001159

Review Digital Health Interventions Supporting Recovery ... This scoping review provides a comprehensive overview of digital health interventions designed to support the recovery of ICU patients and their family members.

8. bjsm.bmj.com bjsm.bmj.com/content/57/20/1295

Effects of a 16-week home-based exercise training ... We investigated the effects of a home-based exercise training (HBET) programme on HRQoL and health-related outcomes in survivors of severe/critical COVID-19.