Precision exercise program to help sepsis survivors improve their fitness
Precision Exercise to Improve Patient Outcomes in Sepsis Survivors: PRECISE Study
This study is testing a personalized exercise program to see if it can help people who survived sepsis get fitter compared to those who just receive regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05784740 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on a 12-week precision exercise training intervention aimed at enhancing exercise tolerance in survivors of sepsis. Participants will engage in individualized, nonlinear periodized strength and aerobic exercise training three times a week, while a control group will receive usual care and lifestyle advice. The study will assess the efficacy of this tailored exercise program by comparing the exercise group's performance on constant load exercise tests to that of the control group. Additionally, participants will complete questionnaires and provide blood samples to evaluate patient-reported outcomes and immune function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who have experienced sepsis and have reduced cardiorespiratory fitness.
Not a fit: Patients with recent cardiac or cerebral vascular events, uncontrolled hypertension, or those on supplemental oxygen may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve exercise tolerance and overall health outcomes for sepsis survivors.
How similar studies have performed: While traditional exercise training approaches have shown limited success in sepsis, this precision exercise method is novel and has not been previously tested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * At least 19 years of age * ≥60 days prior to study enrollment, known or suspected infection that includes at least two of the following clinical criteria that together constitute a new bedside clinical score termed quickSOFA (qSOFA): respiratory rate \>22breaths/min, altered mentation, or systolic blood pressure \<100mmHg. * Cardiorespiratory fitness \<80% of age and sex-predicted norms * Can commit to attending 3 exercise sessions a week for 12-weeks Exclusion Criteria: * Unable to provide informed consent * On supplemental oxygen * Known previous cardiac or cerebral vascular events in the past 90 days * Diabetes * Autoimmune diseases or on daily immunomodulatory drugs * Obstructive sleep apnea * Uncontrolled hypertension * Known pregnancy/ intending to get pregnant within 28 days of enrolling in the study or breastfeeding * Desaturation during exercise SpO2\<85% * Cardiovascular contraindication or musculoskeletal limitations to exercise as assessed during the cardiopulmonary exercise test
Where this trial is running
Vancouver, British Columbia
- St. Paul's Hospital - Centre for Heart Lung Innovation — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Graeme Koelwyn, PhD — University of British Columbia
- Study coordinator: Graeme Koelwyn, PhD
- Email: graeme.koelwyn@hli.ubc.ca
- Phone: 604-682-2344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.