ICU Combined Assessment of Cardio-Respiratory Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ICU Acquired Weakness, Sepsis, Shock, Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
Overview
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:
1. Determine the feasibility of study enrollment and protocol completion. 2. 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. 3. Characterize skeletal muscle microvascular function in ICU survivors using high-resolution NIRS during CPET protocol. 4. Determine the association between impairments in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.
Primary outcome measures
- Rate of enrollment [Time frame: 6 months after ICU discharge]
- Protocol completion [Time frame: Ongoing throughout 12 months after ICU discharge]
- 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.]
- 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.]
- 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 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.]
Secondary outcome measures (6)
- 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.]
Eligibility criteria
Inclusion criteria
- Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 2 centers
- St. Boniface General Hospital — Winnipeg
- Health Sciences Centre Winnipeg — Winnipeg
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. PMID 37234410
- Heyland 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. PMID 26306719
- Muscedere 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. PMID 35680740
Identifiers
NCT: NCT06193980 · HS25592