Bedside Bike Early Mobilization Program for Inpatients

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.

Conditions

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

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.

Sponsors & Collaborators

• Indiana University

  lead OTHER

Principal Investigators

• Chris Gales, DPT · Indiana University

• Babar Khan, MD · Indiana University

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-05

Primary Completion

2026-09-30

Completion

2026-12-31

FDA Device

Yes