Precision Exercise to Improve Outcomes in Sepsis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Other: 12-week precision exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Patients will participate in a 12-week (36 sessions) precision exercise training intervention | Other: 12-week precision exercise training<br>* 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.<br>|
| No Intervention: Attention Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Exercise Tolerance, Exercise Training