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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
Cardiorespiratory fitness <80% of age and sex-predicted norms
At least 19 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
PRECISE Trial Summary
This trial will assess if a 12-week precision exercise training program improves exercise tolerance in sepsis survivors.
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.Check my eligibility
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.See study design
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.
PRECISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart and lung fitness is below 80% of what's expected for my age and sex.
Select...
I am 19 years old or older.
PRECISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in constant load exercise time
Secondary outcome measures
Change in health related quality of life (SF-36)
Other outcome measures
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)
PRECISE 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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Who is running the clinical trial?
Providence Health & ServicesOTHER
115 Previous Clinical Trials
122,491 Total Patients Enrolled
1 Trials studying Sepsis
208 Patients Enrolled for Sepsis
University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,766,577 Total Patients Enrolled
12 Trials studying Sepsis
40,505 Patients Enrolled for Sepsis
Vancouver Coastal Health Research InstituteOTHER
26 Previous Clinical Trials
5,254 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants currently being accepted into the trial?
"This research project, posted March 1st of 2023 and most recently updated on the thirteenth of that same month is not currently seeking participants. Despite this, there are still 179 other studies actively recruiting volunteers."
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