Here is the design of a clinical trial:

Official Title: CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients

Included conditions:
- Intensive Care Unit Acquired Weakness
- Critical Care
- Mechanical Ventilation
- Respiratory Failure

Study Armgroups:
- {'label': 'In-Bed Cycle Ergometer + Routine PT', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive 30 minutes of in-bed cycling once per day, 5 days per week, while they remain in the ICU, for up to a maximum of 28 days. They will also receive routine physiotherapy.', 'interventionNames': ['Device: In-Bed Cycle Ergometer', 'Other: Routine PT']}
- {'label': 'Routine PT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive routine physiotherapy interventions per current institutional practice', 'interventionNames': ['Other: Routine PT']}

Interventions:
- {'type': 'DEVICE', 'name': 'In-Bed Cycle Ergometer', 'description': "Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.", 'armGroupLabels': ['In-Bed Cycle Ergometer + Routine PT'], 'otherNames': ['Restorative Therapies RT300 Supine']}
- {'type': 'OTHER', 'name': 'Routine PT', 'description': "Includes, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out- of bed mobility, ambulation, and assistance with optimizing airway clearance and respiratory function.", 'armGroupLabels': ['In-Bed Cycle Ergometer + Routine PT', 'Routine PT']}

Primary Outcomes:
- {'measure': 'Physical Function Test for ICU-scored (PFIT-s)', 'description': 'Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function.', 'timeFrame': '3 days after ICU discharge'}

Please estimate the sample size based on the assumption: 
Based on a SD of 2.5 points at ICU discharge, 90% power, 0.05 significance level, 25% ICU mortality, 1% mortality in the first 3 days post-ICU discharge, 5% missed primary outcome assessments at 3 days post-ICU, and 5% unblinded assessments.
Sample size
        The sample size of 360 patients (180 patients per group) is based on identifying a 1.0 point mean difference between the Cycling and Routine groups for the PFIT-s 3âdays after ICU discharge,49 corresponding to the minimal clinically important difference identified in psychometric studies.31 50 By logistic regression, the analysis of patients enrolled in two of our previous pilot studies identified that each 1.0 point increase in PFIT-s at ICU discharge was associated with a 40% reduction in the composite outcome of death, readmission to ICU or need for paid assistance after hospital discharge.49 Based on a SD of 2.5 points at ICU discharge,15 51 a 1.0-point difference between groups31 49 50 and 90% power (0.05 Î±), we need to randomise and analyse 266 patients (133 per group). Based on pilot data, we anticipate 25% ICU mortality and 1% mortality in the first 3âdays post-ICU discharge. Among ICU survivors, we anticipate 5% missed primary outcome assessments at 3âdays post-ICU, and 5% unblinded assessments; thus, we will recruit 360 patients overall.