Bedside Bike Early Mobilization Program for Inpatients

NCT07281638 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 28224
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Immobility Harm; Hospital-Acquired Disability; Falls; Deconditioning; In-bed exercise

Outcome Measures

Primary Outcomes (3)

• Device Utilization Feasibility

  Percentage of enrolled participants who achieve at least 75 cumulative minutes of Bedside Bike use during their first 5 hospital days. Success criterion: ≥80% of participants meet this threshold.

  First 5 hospital days (or until discharge if sooner)

• Incidence of Device-Related Adverse Events

  Rate of device-related adverse events (AEs) and serious adverse events (SAEs). Safety success criteria: zero device-related SAEs and ≤5% rate of minor device-related AEs. Device-related events are defined as any adverse outcome directly attributable to the Bedside Bike device itself or its use.

  From enrollment through hospital discharge, approximately 5-7 days on average

• Hospital Length of Stay

  Duration of index hospitalization in days, compared to 2025 unit-specific median length of stay. Target: reduction of ≥0.2 days versus historical benchmark.

  From hospital admission to discharge, approximately 5-7 days on average

Secondary Outcomes (21)

• Change in AM-PAC 6-Clicks Mobility Score

  Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)

• Change in AM-PAC 6-Clicks Activities of Daily Living Score

  Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)

• Discharge Disposition to Home

  At hospital discharge, approximately 5-7 days after admission

• Incidence of Hospital-Acquired Weakness

  At hospital discharge, approximately 5-7 days after admission

• New Institutionalization at 60 Days Post-Discharge

  60 days post-hospital discharge

Study Arms (1)

Intervention Group (receiving Bedside Bike + Usual Care)

EXPERIMENTAL

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.

Device: Bedside Bike

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.

Intervention Group (receiving Bedside Bike + Usual Care)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead

Related Publications (20)

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MeSH Terms

Conditions

Venous Thrombosis; Delirium; Iatrogenic Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Chris Gales, DPT

  Indiana University

  PRINCIPAL INVESTIGATOR

• Babar Khan, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Joyce

CONTACT

317-278-1882; tajoyce@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share