ICU Combined Assessment of Cardio-Respiratory Exercise

Официальное название

Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Rate of enrollment [Срок оценки: 6 months after ICU discharge]
• Protocol completion [Срок оценки: Ongoing throughout 12 months after ICU discharge]
• VO2 peak oxygen uptake [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.]

Вторичные конечные точки (6)

• Functional Independence Measure (FIM) Questionnaire [Срок оценки: Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.]
• Frailty Index [Срок оценки: 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 [Срок оценки: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.]
• Anaerobic threshold [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.]

Критерии участия

Критерии включения

• Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 2 центра

• St. Boniface General Hospital — Winnipeg
• Health Sciences Centre Winnipeg — Winnipeg

Публикации

• 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

Идентификаторы

NCT: NCT06193980 · HS25592

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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