SepsisPRECISENCT05784740
Precision Exercise to Improve Outcomes in Sepsis
A study testing 12-week precision exercise training in people with Sepsis, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- 12-week precision exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital - Centre for Heart Lung Innovation
Vancouver, British Columbia
Graeme Koelwyn, PhD, 604-682-2344 ext. 66221, graeme.koelwyn@hli.ubc.ca
John Boyd, MD, 604-682-2344 ext. 63047, john.boyd@hli.ubc.ca
About this study
Official title: Precision Exercise to Improve Patient Outcomes in Sepsis Survivors: PRECISE Study
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?
Read more
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.
Read the detailed 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.
- Conditions
- Sepsis
- Being tested
- 12-week precision exercise training
- Keywords
- Sepsis, Exercise Tolerance, Exercise Training
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week precision exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Patients will participate in a 12-week (36 sessions) precision exercise training intervention Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-weeks
Secondary outcomes (1)
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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start17 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, Simon Fraser University, St. Paul's Hospital, Canada, Providence Health & Services
- Responsible party
- Principal investigator, Graeme Koelwyn, University of British Columbia
- Investigators
- Graeme Koelwyn, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784740
- Sponsor's protocol ID
- H22-02879
- Acronym
- PRECISE
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available as required by a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Exercise to Improve Patient Outcomes in Sepsis Survivors: PRECISE Study
- ClinicalTrials.gov ID
- NCT05784740
- Acronym / sponsor ID
- PRECISE / H22-02879
- Conditions
- Sepsis
- Keywords
- Sepsis, Exercise Tolerance, Exercise Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, Simon Fraser University, St. Paul's Hospital, Canada, Providence Health & Services
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: 12-week precision exercise trainingPatients will participate in a 12-week (36 sessions) precision exercise training intervention |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week precision exercise trainingThe 12-week exercise intervention will consist of both aerobic and strength exercise training performed 3x per week using an individualized and nonlinear periodized approach. | Other | Exercise Intervention |
Primary outcome
Change in constant load exercise time
Time frame: 12-weeks
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.
1 secondary outcome
Change in health related quality of life (SF-36)
Time frame: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available as required by a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Graeme Koelwyn, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week precision exercise training in people with Sepsis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graeme Koelwyn, PhD (604-682-2344 ext. 66221, graeme.koelwyn@hli.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in constant load exercise time (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.