What is the mechanism of action of this treatment?

Sepsis treatment primarily involves antibiotics to combat infection, fluid resuscitation to maintain blood pressure and organ perfusion, and vasopressors to support cardiovascular function. These treatments are crucial as they address the systemic infection and hemodynamic instability characteristic of sepsis. Individualized, nonlinear periodized strength and aerobic exercise training, as studied in the Precision Exercise Training trial, aims to improve physical function and exercise tolerance in sepsis survivors. This matters because enhanced physical fitness can aid recovery, reduce long-term complications, and improve overall quality of life for sepsis patients.

What side effects are associated with this type of intervention?

Common treatments for sepsis include antibiotics, vasopressors, and supportive care. Antibiotics can cause side effects such as gastrointestinal disturbances, allergic reactions, and antibiotic resistance. Vasopressors, like norepinephrine, may lead to arrhythmias, ischemia, and increased cardiac workload. Supportive care, including fluid management, can result in fluid overload and electrolyte imbalances. Exercise interventions, similar to those studied in the Precision Exercise Training trial, generally improve physical function and quality of life in sepsis survivors, but may cause muscle soreness, fatigue, and, in rare cases, cardiovascular strain if not properly monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for sepsis, primarily focusing on antimicrobial therapies, vasopressors like norepinephrine, and supportive care measures. There are no FDA-approved treatments specifically involving precision exercise training for sepsis survivors. The current study on individualized, nonlinear periodized strength and aerobic exercise training is an innovative approach aimed at improving exercise tolerance and overall recovery in sepsis survivors, which is not yet a standard FDA-approved treatment.

What other types of research exist?

Promising novel alternatives to Precision Exercise Training for sepsis patients in 2024 may include: 1) High-Intensity Interval Training (HIIT), which has shown benefits in improving cardiovascular and muscular endurance in various populations; 2) Virtual Reality (VR)-based rehabilitation programs, which can enhance patient engagement and adherence to exercise regimens; 3) Tele-rehabilitation, providing remote, personalized exercise guidance and monitoring; and 4) Integrative approaches combining physical exercise with mindfulness and stress reduction techniques, such as yoga or tai chi, to address both physical and mental health aspects of recovery.

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Precision Exercise Training for Sepsis (PRECISE Trial)

N/A

Recruiting

Led By Graeme Koelwyn, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a personalized exercise program for sepsis survivors to see if it improves their ability to exercise and boosts their immune system. The program includes tailored strength and aerobic exercises over a few months.

Who is the study for?

This trial is for sepsis survivors over 19 years old with reduced cardiorespiratory fitness, who can commit to a 12-week exercise program. They must have had symptoms like fast breathing, confusion, or low blood pressure. It's not for those on oxygen therapy, recent heart events, uncontrolled conditions like diabetes or hypertension, pregnant women, or those unable to consent.

What is being tested?

Researchers are testing if a personalized 12-week exercise program helps improve the ability of sepsis survivors to tolerate physical activity compared to usual care and lifestyle advice. Participants will do strength and aerobic exercises three times weekly and their progress will be measured against an attention control group.

What are the potential side effects?

While specific side effects aren't listed for this type of intervention, general risks may include muscle soreness, fatigue after exercising, and potential exacerbation of underlying health issues during physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in constant load exercise time

Secondary study objectives

Change in health related quality of life (SF-36)

Other study objectives

Change in clinical biomarkers of immune function (absolute lymphocyte count)

Change in clinical biomarkers of immune function (highly sensitive C-reactive protein)

Change in clinical biomarkers of immune function (monocyte HLA-DR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise InterventionExperimental Treatment1 Intervention

Patients will participate in a 12-week (36 sessions) precision exercise training intervention

Group II: Attention ControlActive Control1 Intervention

Patients will not receive exercise training but will be contacted 1x per week via phone to document self-reported physical activity and general wellbeing.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sepsis treatment primarily involves antibiotics to combat infection, fluid resuscitation to maintain blood pressure and organ perfusion, and vasopressors to support cardiovascular function. These treatments are crucial as they address the systemic infection and hemodynamic instability characteristic of sepsis. Individualized, nonlinear periodized strength and aerobic exercise training, as studied in the Precision Exercise Training trial, aims to improve physical function and exercise tolerance in sepsis survivors. This matters because enhanced physical fitness can aid recovery, reduce long-term complications, and improve overall quality of life for sepsis patients.

Integrative aspects of a human model of endotoxemia.