ICU Combined Assessment of Cardio-Respiratory Exercise

NCT06193980 | Recruiting

• 1 other identifier: HS25592
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.

Secondary Outcomes (7)

• Functional Independence Measure (FIM) Questionnaire

  Questionnaire will be conducted on up to 2 (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.

• Frailty Index

  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

  Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.

• Anaerobic threshold

  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)

  Tests will be conducted on up to two (2) different occasions after ICU discharge: (i) 6 months, and (ii) 12 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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 Winnipeg

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock; Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Behavior

Study Officials

• Asher Mendelson, MD PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asher Mendelson, MD PhD

CONTACT

204-787-1634; Asher.Mendelson@umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 8, 2024
• Study Start: December 15, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)