Precision Exercise to Improve Outcomes in Sepsis

NCT05784740 | Recruiting DMC

• 1 other identifier: H22-02879
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; Exercise Tolerance; Exercise Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in health related quality of life (SF-36)

  12-weeks

Other Outcomes (3)

• Change in clinical biomarkers of immune function (highly sensitive C-reactive protein)

  12-weeks

• Change in clinical biomarkers of immune function (absolute lymphocyte count)

  12-weeks

• Change in clinical biomarkers of immune function (monocyte HLA-DR)

  12-weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Other: 12-week precision exercise training

Attention Control

NO INTERVENTION

Patients will not receive exercise training but will be contacted 1x per week via phone to document self-reported physical activity and general wellbeing.

Interventions

12-week precision exercise training 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.

Exercise Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator
• Simon Fraser University: collaborator
• St. Paul's Hospital, Canada: collaborator
• Providence Health & Services: collaborator

Study Sites (1)

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

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Graeme Koelwyn, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graeme Koelwyn, PhD

CONTACT

604-682-2344; graeme.koelwyn@hli.ubc.ca

John Boyd, MD

CONTACT

604-682-2344; john.boyd@hli.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: April 17, 2023
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after publication and for up to 36 months post publication
• 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.

Locations

CA (1)