In-bed cycling and stepping for critically ill patients
Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients: A Study Protocol for a Pilot Randomized Controlled Clinical Trial
This study tests if adding in-bed cycling and stepping exercises can help critically ill patients recover better from weakness after being in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT05868070 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of incorporating in-bed cycling and stepping exercises into the rehabilitation of critically ill patients suffering from ICU-acquired weakness. Participants will be randomly assigned to either a control group receiving conventional rehabilitation or an intervention group that includes in-bed cycling/stepping exercises tailored to their level of consciousness and motor function. The study aims to assess whether this additional exercise can enhance recovery and improve overall health outcomes for patients in the ICU. It is a single-center, open-label, pilot, randomized, parallel-group study.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged 45 and older who require at least 48 hours of ICU care.
Not a fit: Patients with severe neurologic disorders or those expected to be discharged from the ICU within three days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for critically ill patients.
How similar studies have performed: While the specific combination of in-bed cycling and stepping is novel, similar rehabilitation approaches have shown promise in improving outcomes for critically ill patients in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 45 * Admission to ICU ≤ 72 hours * Patient deemed to need ≥ 48 hours of ICU care * Premorbid functional ambulation category≥ 2 Exclusion Criteria: * Neurologic disorders i.Central nervous system: acute stroke, advanced dementia, hypoxic-ischemic encephalopathy ii. Peripheral nervous system: amyotrophic lateral sclerosis, myasthenia gravis, acute inflammatory demyelinating polyneuropathy * Acute deep venous thrombosis, pulmonary embolism * Pneumothorax * External fixator, superficial metallic implants, amputation, eschar, etc * Expected ICU discharge within 3 days of admission * Pregnant * Difficulty in obtaining consent (rejection, no family, if the family does not agree) * If the life expectancy is less than 6 months
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Woo Hyung Lee, MD, PhD — Seoul National University Hospital
- Study coordinator: Woo Hyung Lee, MD, PhD
- Email: whlee909@snu.ac.kr
- Phone: 82-10-4640-6283
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.