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Precision Exercise to Improve Outcomes in Sepsis

NCT ID: NCT05784740

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2025-08-31

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.

Conditions

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Sepsis

Keywords

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Sepsis Exercise Tolerance Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exercise Intervention

Patients will participate in a 12-week (36 sessions) precision exercise training intervention

Group Type EXPERIMENTAL

12-week precision exercise training

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver Coastal Health Research Institute

OTHER

Sponsor Role collaborator

Simon Fraser University

OTHER

Sponsor Role collaborator

St. Paul's Hospital, Canada

OTHER

Sponsor Role collaborator

Providence Health & Services

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Graeme Koelwyn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Graeme Koelwyn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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St. Paul's Hospital - Centre for Heart Lung Innovation

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Graeme Koelwyn, PhD

Role: CONTACT

Phone: 604-682-2344

Email: [email protected]

John Boyd, MD

Role: CONTACT

Phone: 604-682-2344

Email: [email protected]

Facility Contacts

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Graeme Koelwyn, PhD

Role: primary

John Boyd, MD

Role: backup

Graeme Koelwyn, PhD

Role: backup

John Boyd, MD

Role: backup

Neil Eves, PhD

Role: backup

Other Identifiers

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H22-02879

Identifier Type: -

Identifier Source: org_study_id