Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-01-05
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients
NCT02757131
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
NCT02185989
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
NCT07294131
Redesigning Patient Handling Tasks to Prevent Nursing Back Injuries
NCT00012844
Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients
NCT05868070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Immobility during hospitalization is a widespread and often preventable cause of disability, particularly among older adults and patients recovering from critical illness. Research demonstrates that very modest activity confers significant benefits: walking just 275 steps per day reduces 30-day readmissions by 10% in older inpatients, and a single 20-minute cycling session on weekdays shortens length of stay and improves functional recovery in ventilated ICU patients. However, most patients remain largely immobile despite being physiologically capable of low-intensity exercise.
The Bedside Bike addresses key barriers to inpatient mobility by eliminating the need to transfer out of bed (reducing fall risk), requiring less than 1 minute of staff setup time (addressing staffing constraints), providing adjustable resistance for progressive exercise, and allowing patients to exercise independently without navigating hallways with IV lines and catheters. The device is FDA-cleared (Class I, product code ION, 21 CFR §890.5370) and has been tested with healthcare providers and healthy volunteers without safety concerns.
Study Design and Implementation:
This is a prospective, single-arm quality improvement implementation study conducted across three Indiana University Health hospital units: IU Methodist Post-ICU step-down unit, IU Bloomington ortho/neuro and medical/surgical units, and IU North medical/surgical unit. The study uses a pragmatic design embedded within routine clinical care, with contemporaneous historical unit-level metrics from 2025 serving as comparison benchmarks.
Device Setup and Operation:
After informed consent, the Bedside Bike is installed at the bedside and patients receive training on its use. The device clamps securely to the bed frame with pedals positioned approximately 10 cm above the mattress. Patients can adjust resistance via a dial and exercise at their own pace, targeting at least one 15-minute session daily. A quick-release lever allows the device to be disengaged in under 2 seconds if needed for patient transfers or clinical procedures.
The Bedside Bike includes a Bluetooth-enabled telemetry module that automatically records exercise metrics including duration, revolutions per minute, and resistance level. Data is encrypted and uploaded nightly to a secure REDCap database at Indiana University. Between patients, the device is cleaned with standard hospital disinfectant, and Clinical Engineering performs weekly quality assurance checks.
Integration with Standard Care:
Patients continue all standard medical care without restrictions. Physical therapy, occupational therapy, and progressive ambulation programs proceed as usual. The Bedside Bike is designed to augment-not replace-skilled therapy sessions. There are no restrictions on pain medications, sleep aids, or nutritional support. Cycling is temporarily paused during hemodialysis or when telemetry alarms require clinical attention.
Data Safety Monitoring:
The Principal Investigator leads weekly data safety monitoring huddles to review enrollment progress, device utilization patterns, and adverse events. Any unanticipated serious adverse event triggers immediate IRB notification within 48 hours. The study protocol includes automatic pause criteria: enrollment halts if any device-related serious adverse event occurs or if feasibility drops below 40% for two consecutive weeks, pending comprehensive safety review.
Duration and Follow-up:
The enrollment period spans 3 months (February through April 2026) with approximately 16 patients enrolled monthly across all sites. Each participant is followed through hospital discharge plus 60 days post-discharge. The final 60-day follow-up is completed by the end of June 2026, with database lock and analysis extending through September 2026.
Statistical Design:
With N=80 participants, the study provides 90% power (α=0.05, two-tailed, assuming SD of 2 days) to detect a clinically meaningful 0.2-day reduction in length of stay compared to historical unit averages. This sample size accounts for potential dropouts and incomplete data. Missing data under 5% will be handled using multiple imputation (m=5 iterations); higher rates of missingness will default to complete-case analysis.
This pragmatic feasibility study will provide critical data on device utilization, safety profile, and preliminary effectiveness signals to inform the design of larger randomized controlled trials and guide clinical implementation strategies for in-bed cycling technology across diverse inpatient populations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
110 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Babar Khan, MD, MS
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chris Gales, DPT
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Babar Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Heit JA, Melton LJ 3rd, Lohse CM, Petterson TM, Silverstein MD, Mohr DN, O'Fallon WM. Incidence of venous thromboembolism in hospitalized patients vs community residents. Mayo Clin Proc. 2001 Nov;76(11):1102-10. doi: 10.4065/76.11.1102.
Regenbogen SE, Cain-Nielsen AH, Syrjamaki JD, Chen LM, Norton EC. Spending On Postacute Care After Hospitalization In Commercial Insurance And Medicare Around Age Sixty-Five. Health Aff (Millwood). 2019 Sep;38(9):1505-1513. doi: 10.1377/hlthaff.2018.05445.
Brown CJ, Friedkin RJ, Inouye SK. Prevalence and outcomes of low mobility in hospitalized older patients. J Am Geriatr Soc. 2004 Aug;52(8):1263-70. doi: 10.1111/j.1532-5415.2004.52354.x.
Brown CJ, Redden DT, Flood KL, Allman RM. The underrecognized epidemic of low mobility during hospitalization of older adults. J Am Geriatr Soc. 2009 Sep;57(9):1660-5. doi: 10.1111/j.1532-5415.2009.02393.x. Epub 2009 Aug 4.
Pasina L, Cortesi L, Tiraboschi M, Nobili A, Lanzo G, Tettamanti M, Franchi C, Mannucci PM, Ghidoni S, Assolari A, Brucato A; REPOSI Investigators. Risk factors for three-month mortality after discharge in a cohort of non-oncologic hospitalized elderly patients: Results from the REPOSI study. Arch Gerontol Geriatr. 2018 Jan;74:169-173. doi: 10.1016/j.archger.2017.10.016.
Cao J, Wang T, Li Z, Liu G, Liu Y, Zhu C, Jiao J, Li J, Li F, Liu H, Liu H, Song B, Jin J, Liu Y, Wen X, Cheng S, Wan X, Wu X. Factors associated with death in bedridden patients in China: A longitudinal study. PLoS One. 2020 Jan 29;15(1):e0228423. doi: 10.1371/journal.pone.0228423. eCollection 2020.
Yang SY, Kim ES, Jeon G, Choi KY, Kim JK. Enhanced adhesion of osteoblastic cells on polystyrene films by independent control of surface topography and wettability. Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1689-95. doi: 10.1016/j.msec.2012.12.081. Epub 2013 Jan 2.
English KL, Paddon-Jones D. Protecting muscle mass and function in older adults during bed rest. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):34-9. doi: 10.1097/MCO.0b013e328333aa66.
Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med. 2013 Jan 10;368(2):100-2. doi: 10.1056/NEJMp1212324. No abstract available.
Drummond MJ, Dickinson JM, Fry CS, Walker DK, Gundermann DM, Reidy PT, Timmerman KL, Markofski MM, Paddon-Jones D, Rasmussen BB, Volpi E. Bed rest impairs skeletal muscle amino acid transporter expression, mTORC1 signaling, and protein synthesis in response to essential amino acids in older adults. Am J Physiol Endocrinol Metab. 2012 May 15;302(9):E1113-22. doi: 10.1152/ajpendo.00603.2011. Epub 2012 Feb 14.
Chizhikov VV, Millen KJ. Control of roof plate development and signaling by Lmx1b in the caudal vertebrate CNS. J Neurosci. 2004 Jun 23;24(25):5694-703. doi: 10.1523/JNEUROSCI.0758-04.2004.
Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
Heit JA, O'Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, Melton LJ 3rd. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002 Jun 10;162(11):1245-8. doi: 10.1001/archinte.162.11.1245.
Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, Huang W, Zayaruzny M, Emery L, Anderson FA Jr; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 Feb 2;371(9610):387-94. doi: 10.1016/S0140-6736(08)60202-0.
Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003 Oct 8;290(14):1868-74. doi: 10.1001/jama.290.14.1868.
Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov;62(11):2180-4. doi: 10.1111/jgs.13095. Epub 2014 Oct 30.
Agmon M, Zisberg A, Gil E, Rand D, Gur-Yaish N, Azriel M. Association Between 900 Steps a Day and Functional Decline in Older Hospitalized Patients. JAMA Intern Med. 2017 Feb 1;177(2):272-274. doi: 10.1001/jamainternmed.2016.7266. No abstract available.
Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8. doi: 10.1046/j.1532-5415.2002.50601.x.
Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
28224
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.