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NOT YET RECRUITING
NCT07281638
NA

Bedside Bike Early Mobilization Program for Inpatients

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07-05

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

Yes

Interventions

DEVICE

Bedside Bike

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.