ICU Acquired WeaknessICU-CARENCT06193980
ICU Combined Assessment of Cardio-Respiratory Exercise
An observational study of ICU Acquired Weakness and Sepsis, run by University of Manitoba at 2 sites in Canada.
Trial summary
This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness, Sepsis, Shock
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Dec 2023to Dec 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU survivor: Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital
Who may be able to join
- Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.
Who cannot join
- Unable to provide consent
- Trajectory of health expected to be significantly limited in the upcoming 12 months
- those who self-report that they cannot climb at least one flight of stairs due to limited exercise capacity
- have significant orthopedic or musculoskeletal impairment affecting mobility
- have a medical history of neuromuscular disease
- ongoing respiratory limitations (i.e., supplemental oxygen)
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- significant heart disease (i.e. ejection fraction less than 30%, unstable ischemic heart disease, severe valvular heart disease)
- a body mass index (BMI) of ≥ 40 kg/m2 (impacting NIRS signal due to adipose tissue thickness)
- if participant's primary residence is a significant distance from the participating study site
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Asher Mendelson, MD PhD, 204-787-1634, asher.mendelson@umanitoba.ca
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Asher Mendelson, MD PhD, 204-787-1634, asher.mendelson@umanitoba.ca
About this study
Official title: Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.
Read the detailed description
This longitudinal study will assess cardiovascular fitness and microvascular function through two (2) follow-ups after ICU discharge: at (i) 6 months, and (ii) 12 months. The first timepoint will be at 6 months will be required, and the second timepoint at 12 months will be optional based on participant availability. The goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.
Specific goals are:
- Determine the feasibility of study enrollment and protocol completion.
- Evaluate peak oxygen uptake and oxygen on/off kinetics in ICU survivors using a standardized cardiopulmonary exercise test (CPET) protocol. This protocol has been adapted from Santana et. al. (2025) for the ICU population.
- Characterize skeletal muscle microvascular function in ICU survivors using high-resolution NIRS during CPET protocol.
- Determine the association between impairments in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.
- Conditions
- ICU Acquired Weakness, Sepsis, Shock, Critical Illness, Microcirculation
- Keywords
- ICU Survivors, Oxygen Delivery, Microcirculation, skeletal muscle, Exercise, near-infrared spectroscopy, cardiopulmonary exercise test, cardiovascular physiology
- Medical subject headings
- Sepsis, Shock, Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU survivors | Patients who have received prolonged mechanical ventilation (7 days or more) in the intensive care unit (ICU), and have been discharged from hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrollment
Rate of participant enrollment in the study will be recorded. Feasibility of enrollment will be one participant per month.
Measured: 6 months after ICU discharge
Protocol completion
The number of completed sessions within 12 months for each eligible patient will be recorded. Feasibility target will be ≥ 80% completion of the protocol at 6 month time point for all participants.
Measured: Ongoing throughout 12 months after ICU discharge
VO2 peak oxygen uptake
Peak Oxygen uptake (VO2, mL/kg/min) will be measured during incremental exercise on a cycle ergometer during cardiopulmonary exercise testing (CPET).
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
oxygen on/off kinetics
time constant (seconds) of oxygen uptake will be assessed at the transition to constant work rate exercise at the beginning of CPET; time constant (seconds) of oxygen uptake will also be assessed at the transition to rest at the end of CPET after reaching VO2 peak.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
NIRS deoxygenation during exercise (deoxy-hemoglobin)
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by increase in deoxy-hemoglobin will be recorded throughout exercise. Higher values indicate impaired oxygen delivery to tissue.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
NIRS deoxygenation during exercise (tissue saturation index)
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by decrease in tissue saturation index will be recorded throughout exercise. Lower values indicate impaired oxygen delivery to tissue.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Secondary outcomes (6)
Functional Independence Measure (FIM) Questionnaire
will assess functional capacity, and will be administered by research staff. Response will be sought directly from the patient. FIM is scored with motor (13-91) and cognitive (5-35). Lower scores indicate lower functional independence
Measured: Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Frailty Index
The frailty index identifies 42 deficits, each coded as 0 (absent), 1 (present), or 0.5 (where intermediate values were possible). It was calculated as the cumulative proportion of deficits present (minimum score 0; maximum score 1.0), and then graded as mild (0 and 0.2), moderate (0.2 and 0.4) or severe frailty (>0.4). See references for studies where Index is derived.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Medical Research Council (MRC) sum score
Medical Research Council (MRC) sum score tests power in muscle groups for upper and lower extremities and score is tallied as the sum of all tested muscles. Value ranges from complete paralysis (0/60) to full strength (60/60). Score less than 48/60 denotes clinically significant weakness.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Anaerobic threshold
Work rate at anaerobic threshold (AT), represented at percentage of VO2 peak will be quantified with CPET. This corresponds to the time where oxygen (O2) utilization and carbon dioxide (CO2) production curves begin to diverge.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Vital Capacity (FVC)
Standard spirometry techniques are used to quantify the maximum volume of expired breath (Litres), and represented as a %predicted compared to reference values. All tests are performed in accordance with standard ATS guidelines.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Expiratory Volume at 1-second (FEV1)
Standard spirometry techniques are used to quantify the volume of expired breath (Litres) in 1 second, and represented as a %predicted compared to reference values. All tests are performed in accordance with standard ATS guidelines.
Measured: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Dec 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Mendelson, University of Manitoba
- Investigators
- Asher Mendelson, MD PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193980
- Sponsor's protocol ID
- HS25592
- Acronym
- ICU-CARE
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendelson AA, Erickson D, Villar R. The role of the microcirculation and integrative cardiovascular physiology in the pathogenesis of ICU-acquired weakness. Front Physiol. 2023 May 10;14:1170429. doi: 10.3389/fphys.2023.1170429. eCollection 2023.
PubMed 37234410Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26.
PubMed 26306719Muscedere J, Bagshaw SM, Boyd G, Sibley S, Norman P, Day A, Hunt M, Rolfson D. The frailty, outcomes, recovery and care steps of critically ill patients (FORECAST) study: pilot study results. Intensive Care Med Exp. 2022 Jun 10;10(1):23. doi: 10.1186/s40635-022-00446-7.
PubMed 35680740Blunderfield B, Santana J, Majumdar R, Herath I, Blouw M, Ramsey C, Olafson K, Sousa M, Boyd JG, Rozenberg D, Cowley K, Herridge MS, Batt J, Horsburgh M, Duhamel T, Christiansen D, Villar R, Mendelson AA. Standardized Single-Session Cardiopulmonary Exercise Test for Measuring Peak Oxygen Uptake, Oxygen On/Off Kinetics, and Skeletal Muscle Oxygenation in ICU Survivors-ICU Combined Assessment of Cardiorespiratory Exercise (ICU-CARE) Study: Protocol for a Cross-Sectional Observational Study. JMIR Res Protoc. 2026 Jul 14;15:e92346. doi: 10.2196/92346.
PubMed 42446403
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
- ClinicalTrials.gov ID
- NCT06193980
- Acronym / sponsor ID
- ICU-CARE / HS25592
- Conditions
- ICU Acquired Weakness, Sepsis, Shock, Critical Illness, Microcirculation
- Keywords
- ICU Survivors, Oxygen Delivery, Microcirculation, skeletal muscle, Exercise, near-infrared spectroscopy, cardiopulmonary exercise test, cardiovascular physiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Jan 2024 (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.
This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.
Detailed description
This longitudinal study will assess cardiovascular fitness and microvascular function through two (2) follow-ups after ICU discharge: at (i) 6 months, and (ii) 12 months. The first timepoint will be at 6 months will be required, and the second timepoint at 12 months will be optional based on participant availability. The goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.
Specific goals are:
- Determine the feasibility of study enrollment and protocol completion.
- Evaluate peak oxygen uptake and oxygen on/off kinetics in ICU survivors using a standardized cardiopulmonary exercise test (CPET) protocol. This protocol has been adapted from Santana et. al. (2025) for the ICU population.
- Characterize skeletal muscle microvascular function in ICU survivors using high-resolution NIRS during CPET protocol.
- Determine the association between impairments in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU survivors | – | –Patients who have received prolonged mechanical ventilation (7 days or more) in the intensive care unit (ICU), and have been discharged from hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU survivor: Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital
Key inclusion criteria (1 listed)
- Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.
Key exclusion criteria (9 listed)
- Unable to provide consent
- Trajectory of health expected to be significantly limited in the upcoming 12 months
- those who self-report that they cannot climb at least one flight of stairs due to limited exercise capacity
- have significant orthopedic or musculoskeletal impairment affecting mobility
- have a medical history of neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of enrollment
Time frame: 6 months after ICU discharge
Rate of participant enrollment in the study will be recorded. Feasibility of enrollment will be one participant per month.
Protocol completion
Time frame: Ongoing throughout 12 months after ICU discharge
The number of completed sessions within 12 months for each eligible patient will be recorded. Feasibility target will be ≥ 80% completion of the protocol at 6 month time point for all participants.
VO2 peak oxygen uptake
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Peak Oxygen uptake (VO2, mL/kg/min) will be measured during incremental exercise on a cycle ergometer during cardiopulmonary exercise testing (CPET).
oxygen on/off kinetics
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
time constant (seconds) of oxygen uptake will be assessed at the transition to constant work rate exercise at the beginning of CPET; time constant (seconds) of oxygen uptake will also be assessed at the transition to rest at the end of CPET after reaching VO2 peak.
NIRS deoxygenation during exercise (deoxy-hemoglobin)
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by increase in deoxy-hemoglobin will be recorded throughout exercise. Higher values indicate impaired oxygen delivery to tissue.
NIRS deoxygenation during exercise (tissue saturation index)
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
NIRS will be applied to the vastus lateralis during exercise testing. Deoxygenation profile, as measured by decrease in tissue saturation index will be recorded throughout exercise. Lower values indicate impaired oxygen delivery to tissue.
6 secondary outcomes
Functional Independence Measure (FIM) Questionnaire
Time frame: Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Frailty Index
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Medical Research Council (MRC) sum score
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Anaerobic threshold
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Vital Capacity (FVC)
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
Forced Expiratory Volume at 1-second (FEV1)
Time frame: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.
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 15 Jun 2026.
- Background: PubMed 37234410Mendelson AA, Erickson D, Villar R. The role of the microcirculation and integrative cardiovascular physiology in the pathogenesis of ICU-acquired weakness. Front Physiol. 2023 May 10;14:1170429. doi: 10.3389/fphys.2023.1170429. eCollection 2023.
- Background: PubMed 26306719Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26.
- Background: PubMed 35680740Muscedere J, Bagshaw SM, Boyd G, Sibley S, Norman P, Day A, Hunt M, Rolfson D. The frailty, outcomes, recovery and care steps of critically ill patients (FORECAST) study: pilot study results. Intensive Care Med Exp. 2022 Jun 10;10(1):23. doi: 10.1186/s40635-022-00446-7.
- Derived from this study: PubMed 42446403Blunderfield B, Santana J, Majumdar R, Herath I, Blouw M, Ramsey C, Olafson K, Sousa M, Boyd JG, Rozenberg D, Cowley K, Herridge MS, Batt J, Horsburgh M, Duhamel T, Christiansen D, Villar R, Mendelson AA. Standardized Single-Session Cardiopulmonary Exercise Test for Measuring Peak Oxygen Uptake, Oxygen On/Off Kinetics, and Skeletal Muscle Oxygenation in ICU Survivors-ICU Combined Assessment of Cardiorespiratory Exercise (ICU-CARE) Study: Protocol for a Cross-Sectional Observational Study. JMIR Res Protoc. 2026 Jul 14;15:e92346. doi: 10.2196/92346.
- Individual participant dataSharing planned: No
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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.
Asher Mendelson, MD PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Acquired Weakness and Sepsis, run by University of Manitoba at 2 sites 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 1 inclusion and 9 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Asher Mendelson, MD PhD (204-787-1634, Asher.Mendelson@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of enrollment (time frame: 6 months after ICU discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193980, which also lists 4 linked publications.
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 15 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.