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WithdrawnNo phase

Bedside Bike Early Mobilization Program for Inpatients

Key facts

Who runs it
Indiana University
Trial code
Status
Withdrawn
Started
5 Jul 2026
Expected to end
31 Dec 2026
Type of study
Interventional
Treatments tested
  • Bedside Bike
Record updated
24 August 2026
Why it stopped
Unable to open up the site for recruitment.

Who can take part

Age
18 years to 110 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Concurrent enrollment in another interventional clinical trial that would conflict with study procedures or outcomes
  • Uncontrolled cardiac arrhythmia
  • Active deep vein thrombosis (DVT) without therapeutic anticoagulation
  • 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
  • Open lower extremity wounds within the pedal arc area
  • Lower limb fracture requiring traction or immobilization
  • Body mass index (BMI) >45 kg/m² (exceeds device reach limit)
  • Current pregnancy

About the trial

What the trial wants to find out

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.

The group in the trial

  • Intervention Group (receiving Bedside Bike + Usual Care)Treatment being tested

    All enrolled participants receive the Bedside Bike device plus standard hospital care. Installed within 24 hours of admission, patients are trained on device operation and safety. Setup takes \<1 minute. Patients use the device daily throughout hospitalization, targeting ≥15 minutes per session. Exercise is self-paced with adjustable resistance via patient-controlled dial. Recumbent (in-bed) cycling allows unsupervised, patient-initiated use without staff presence. Average duration is 5-7 days (enrollment to discharge). Participants continue all standard care including physical/occupational therapy, ambulation, medications, and nutrition.

    Treatment: Bedside Bike

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
24 August 2026