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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
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.
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.
Integrative aspects of a human model of endotoxemia.
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,459 Previous Clinical Trials
2,484,849 Total Patients Enrolled
12 Trials studying Sepsis
40,505 Patients Enrolled for Sepsis
St. Paul's Hospital, CanadaOTHER
46 Previous Clinical Trials
13,088 Total Patients Enrolled
Providence Health & ServicesOTHER
123 Previous Clinical Trials
823,784 Total Patients Enrolled
1 Trials studying Sepsis
208 Patients Enrolled for Sepsis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with obstructive sleep apnea.I am unable to understand or sign the consent form.I use supplemental oxygen.My heart and lung fitness is below 80% of what's expected for my age and sex.I have diabetes.I have had a heart attack or stroke in the last 3 months.I have an autoimmune disease or take daily immunomodulatory drugs.My high blood pressure is not under control.I am 19 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Intervention
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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