Hospital immobility leads to serious complications including muscle loss, weakness, delirium, pressure ulcers, and blood clots. Despite being medically stable, hospitalized patients spend over 90% of their time in bed due to staffing shortages, fall risks, and limited physical therapy availability. Within one week of admission, patients can lose approximately 2% of thigh muscle mass per day, and nearly half develop clinically significant hospital-acquired weakness.The Bedside Bike is a portable, low-resistance exercise device that clamps securely to hospital beds, allowing patients to perform leg and arm cycling exercises safely without leaving their bed. This study will evaluate whether hospitalized patients at Indiana University Health facilities can feasibly and safely use the Bedside Bike to maintain mobility during their hospital stay.This quality improvement study will enroll 80 adult inpatients expected to stay at least 3 days. All participants will receive the Bedside Bike in addition to usual care (standard physical therapy and medical treatment). The study will measure how often patients use the device, whether it is safe (tracking any device-related problems), and whether it may help improve outcomes such as hospital length of stay, functional mobility scores, discharge to home, and rates of hospital-acquired weakness. Participants will have functional assessments at admission and discharge, use the Bedside Bike throughout their hospitalization (targeting at least 15 minutes daily), and be followed for 60 days after discharge to track readmissions, falls, living arrangements, and mortality.
Age 18 years or older
Admitted to participating hospital unit within 24 hours or less
Expected hospital stay of at least 3 days
Able to follow one-step commands
Hemodynamic instability requiring vasopressor support with systolic blood pressure <90 mmHg
Requiring fraction of inspired oxygen (FiO₂) >0.6 or positive end-expiratory pressure (PEEP) >8 cm H₂O
Uncontrolled cardiac arrhythmia
Open lower extremity wounds within the pedal arc area
Single group
Bedside Bike
DeviceThe Bedside Bike is a Class I medical device (21 CFR §890.5370, product code ION) featuring a magnetic resistance mechanism powering arm and leg pedal systems with a universal clamp for standard hospital bed frames. Key safety features include smooth surfaces without sharp edges, immediate stop mechanism with no momentum carry-over, cushioned pedals supporting single-pedal operation for hemiparesis, self-retracting tether cable preventing entanglement, battery-powered operation eliminating tripping hazards, nearly silent operation, lightweight construction, and soft-start/soft-stop resistance adjustment.
Device Utilization Feasibility
Percentage of enrolled participants who achieve at least 75 cumulative minutes of Bedside Bike use during their first 5 hospital days. Success criterion: ≥80% of participants meet this threshold.
Incidence of Device-Related Adverse Events
Rate of device-related adverse events (AEs) and serious adverse events (SAEs). Safety success criteria: zero device-related SAEs and ≤5% rate of minor device-related AEs. Device-related events are defined as any adverse outcome directly attributable to the Bedside Bike device itself or its use.
Hospital Length of Stay
Duration of index hospitalization in days, compared to 2025 unit-specific median length of stay. Target: reduction of ≥0.2 days versus historical benchmark.
Change in AM-PAC 6-Clicks Mobility Score
Change in Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" Basic Mobility Inpatient Short Form score from baseline to discharge. Target: improvement of ≥2 points. Score range 6-24, with higher scores indicating better mobility function.
Change in AM-PAC 6-Clicks Activities of Daily Living Score
Change in Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" Activities of Daily Living (ADL) Inpatient Short Form score from baseline to discharge. Score range 6-24, with higher scores indicating better ADL function.
Discharge Disposition to Home
Percentage of participants discharged directly home (versus inpatient rehabilitation facility, skilled nursing facility, long-term acute care hospital, or death). Target: increase of ≥7% compared to 2025 unit-specific historical rate.
Incidence of Hospital-Acquired Weakness
Percentage of participants with hospital-acquired weakness defined as Medical Research Council (MRC) sum score \<48 at discharge. MRC sum score assesses strength in 12 muscle groups bilaterally (range 0-60), with scores \<48 indicating clinically significant weakness. Target incidence: \<30%.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
