Bedside Bike Early Mobilization Program for Inpatients

Sponsor
Indiana University
Study ID
NCT07281638
Status
Not Yet Recruiting

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Conditions

  • Deep Venous Thrombosis
  • Delirium
  • Fall
  • Hospital Acquired Condition
  • Immobility Syndrome
  • Mobility Limitation

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • Bedside Bike — DEVICE
    The 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.

Study Details

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 Dates

First listed
Dec 15, 2025
Start date
Jul 5, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group (receiving Bedside Bike + Usual Care)
    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.

Primary Outcome Measure

Device Utilization Feasibility [ Time Frame: First 5 hospital days (or until discharge if sooner) ]

Central Contacts

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