Precision Exercise to Improve Outcomes in Sepsis (PRECISE)

Precision Exercise to Improve Patient Outcomes in Sepsis Survivors: PRECISE Study

The goal of this interventional clinical research study is to assess the efficacy of a 12-week precision exercise training intervention to improve exercise tolerance in sepsis survivors.

The main question it aims to answer is does a 12-week precision exercise training program improve constant load exercise time in sepsis survivors?

Participants will:

• Answer questionnaires related to patient reported outcomes and give a blood sample
• Perform a constant load exercise test
• Complete 12-weeks (3 x per week, 36 session in total) of precision exercise training consisting of individualized, nonlinear periodized strength and aerobic exercise training.

Researchers will compare the exercise group to an attention control group of sepsis survivors who do not receive exercise training but instead undergo usual care procedures and receive general lifestyle advice 1x per week.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: 12-week precision exercise training

Detailed Description

Sepsis is a life threatening condition that results in multi-organ system dysfunction. In those who survive sepsis, many patients present with chronic immune dysregulation (i.e., paradoxical hyperinflammation and immune suppression), leading to high rates of re-hospitalization. In addition, exercise tolerance is significantly reduced both acutely post hospital discharge and long term (~5 years post initial infection). Exercise training is a pleiotropic intervention that has been demonstrated to improve exercise tolerance in a multitude of clinical populations. Aerobic exercise training is also associated with anti-inflammatory and immune-enhancing effects; however, the magnitude of these immunological adaptations is largely dependent on the exercise prescription used. To date, exercise training studies in sepsis have used a more traditional generic linear exercise training approach, which has resulted in minimal or no effect on exercise tolerance. This is in contrast to other clinical populations wherein precision exercise training (e.g., individualized, nonlinear periodized, combined aerobic and strength training) has resulted in greater improvements in exercise tolerance compared to non-specific linear exercise programs, and is considered safe and tolerable. To date, no study has sought to investigate the effects of a precision exercise training intervention on exercise tolerance and immune function in sepsis survivors.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Graeme Koelwyn, PhD; Phone Number: 66221 604-682-2344; Email: graeme.koelwyn@hli.ubc.ca
• Study Contact Backup: Name: John Boyd, MD; Phone Number: 63047 604-682-2344; Email: john.boyd@hli.ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • St. Paul's Hospital - Centre for Heart Lung Innovation
      • Contact: John Boyd, MD
      • Contact: Neil Eves, PhD
      • Contact: Graeme Koelwyn, PhD; Phone Number: 66221 604-682-2344; Email: graeme.koelwyn@hli.ubc.ca
      • Contact: John Boyd, MD; Phone Number: 63047 604-682-2344; Email: john.boyd@hli.ubc.ca
      • Contact: Graeme Koelwyn, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; Patients will participate in a 12-week (36 sessions) precision exercise training intervention	Other: 12-week precision exercise training; The 12-week exercise intervention will consist of both aerobic and strength exercise training performed 3x per week using an individualized and nonlinear periodized approach.
No Intervention: Attention Control; Patients will not receive exercise training but will be contacted 1x per week via phone to document self-reported physical activity and general wellbeing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in constant load exercise time	Individuals will complete a constant-load exercise trial to symptom limitation at ~70% workload maximum (determined by a cardiopulmonary exercise test) on a cycle ergometer pre to post 12-weeks of the intervention period. The primary outcome will be change in time from pre to post test.	12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health related quality of life (SF-36)	The change in health related quality of life measured by the SF-36 component scores pre to post 12-weeks of the intervention period. The SF 36 Medical Outcomes Study Survey (SF-36) is a 36-item survey that measures quality of life over eight domains, including physical functioning, bodily pain, limitations due to physical health problems, limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. Pre-coded numeric values are assigned to each scale, with items scored from 0-100. High scores represent a more favourable health state. Items in each domain are also averaged to create eight separate domain scores.	12-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical biomarkers of immune function (highly sensitive C-reactive protein)	The change in highly sensitive C-reactive protein (mg/L) pre to post 12-weeks of the intervention period.	12-weeks
Change in clinical biomarkers of immune function (absolute lymphocyte count)	The change in absolute lymphocyte count (per mL) pre to post 12-weeks of the intervention period.	12-weeks
Change in clinical biomarkers of immune function (monocyte HLA-DR)	The change in monocyte human leukocyte antigen-DR (per cell) pre to post 12-weeks of the intervention period.	12-weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: St. Paul's Hospital, Canada; Providence Health & Services; Simon Fraser University; Vancouver Coastal Health Research Institute
• Investigators: Principal Investigator: Graeme Koelwyn, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Exercise Training; Sepsis; Exercise Tolerance
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: H22-02879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available as required by a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: 12 months after publication and for up to 36 months post publication
• IPD Sharing Access Criteria: The investigator who proposed to use the data and upon reasonable request. Requests should be directed to graeme.koelwyn@hli.ubc.ca. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No