Evaluating muscle weakness in ICU survivors through exercise testing
Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness
University of Manitoba · NCT06193980
This study is trying to see how problems with blood flow after being in the ICU affect the strength and exercise ability of patients who survived serious illnesses like sepsis and shock.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba (other) |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT06193980 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of sepsis and shock on microcirculation in ICU patients, which can lead to long-term muscle weakness known as ICU-acquired weakness (ICU-AW). It involves four follow-up assessments after ICU discharge at 7 days, 3 months, 6 months, and 12 months to evaluate microvascular function using high-resolution near-infrared spectroscopy (NIRS). The study aims to characterize how microvascular dysfunction affects exercise limitations in survivors of intensive care.
Who should consider this trial
Good fit: Ideal candidates are patients who have been mechanically ventilated for at least 7 days in the medical or surgical ICU and have been discharged.
Not a fit: Patients who are unable to provide consent or have a health trajectory expected to be significantly limited in the next 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle weakness in ICU survivors, enhancing their recovery and quality of life.
How similar studies have performed: While the approach of assessing microvascular function in ICU survivors is gaining attention, this specific study's methodology and focus on long-term outcomes may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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 Winnipeg
Where this trial is running
Winnipeg, Manitoba
- Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada (RECRUITING)
Study contacts
- Principal investigator: Asher Mendelson, MD PhD — University of Manitoba
- Study coordinator: Asher Mendelson, MD PhD
- Email: Asher.Mendelson@umanitoba.ca
- Phone: 204-787-1634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ICU Acquired Weakness, Sepsis, Shock, Critical Illness, Microcirculation, ICU Survivors, Oxygen Delivery, skeletal muscle