Precision Exercise to Improve Outcomes in Sepsis

Sepsis Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784740
• Other study ID #: H22-02879
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Graeme Koelwyn, PhD
• Phone: 604-682-2344
• Email: graeme.koelwyn[@]hli.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital - Centre for Heart Lung Innovation	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Providence Health & Services, Simon Fraser University, St. Paul's Hospital, Canada, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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