Recruiting

Precision Exercise

Sponsor:

University of British Columbia

Code:

NCT05784740

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

12-week precision exercise training

Study Details

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

Study ID

NCT05784740

Start date

Apr 17, 2023

Status verified date

Dec, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

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

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.

Interventions

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.

Primary outcome measure

  • Change in constant load exercise time [ Time Frame: 12-weeks ]

Central Contacts and Locations

Central contacts

Graeme Koelwyn, PhD

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

John Boyd, MD

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

Locations

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

Recruiting

Vancouver, British Columbia, Canada

Contacts

Graeme Koelwyn, PhD

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

John Boyd, MD

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

More Information

Sponsor

University of British Columbia

Last update posted

Dec 18, 2024

Last verified

Dec, 2024

Keywords

  • Sepsis
  • Exercise Tolerance
  • Exercise Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-12-18.