Bedside Bike Early Mobilization Program for Inpatients
Starting soon · Not applicable
Conditions studied: Immobility Syndrome, Deep Venous Thrombosis, Delirium, Hospital Acquired Condition, Fall, Mobility Limitation
In brief
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.
Key facts
- Study ID
- NCT07281638
- Run by
- Indiana University
- People needed
- 80
- Starts
- 2026-07-05
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Anti-gravity leg strength
- Informed consent obtained from patient or legally authorized representative
You may not qualify if…
- 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
- Lower limb fracture requiring traction or immobilization
- Active deep vein thrombosis (DVT) without therapeutic anticoagulation
- Body mass index (BMI) >45 kg/m² (exceeds device reach limit)
- Current pregnancy
- Concurrent enrollment in another interventional clinical trial that would conflict with study procedures or outcomes
Full record on ClinicalTrials.gov
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