ICU Combined Assessment of Cardio-Respiratory Exercise

NCT ID: NCT06193980

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2028-07-31

Brief Summary

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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

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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 goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.

Specific goals are:

1. Evaluate peak oxygen uptake and oxygen on/off kinetics in ICU survivors using a standardized cardiopulmonary exercise test (CPET) protocol.
2. Characterize skeletal muscle microvascular function in ICU survivors using high-resolution NIRS during CPET protocol.
3. Determine the association between impairments in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.

Conditions

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ICU Acquired Weakness Sepsis Shock Critical Illness Microcirculation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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 Winnipeg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Asher Mendelson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asher Mendelson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Asher Mendelson, MD PhD

Role: CONTACT

204-787-1634

Facility Contacts

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Asher Mendelson, MD PhD

Role: primary

204-787-1634

References

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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.

Reference Type BACKGROUND
PMID: 37234410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26306719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35680740 (View on PubMed)

Other Identifiers

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HS25592

Identifier Type: -

Identifier Source: org_study_id

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