Immobility SyndromeBB-STEPNCT07281638
Bedside Bike Early Mobilization Program for Inpatients
A study testing Bedside Bike in people with Immobility Syndrome and Deep Venous Thrombosis, run by Indiana University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Immobility Syndrome, Deep Venous Thrombosis, Delirium
- What is being tested?
- Bedside Bike
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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.
Read the detailed description
Background and Rationale:
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
- Immobility Syndrome, Deep Venous Thrombosis, Delirium, Hospital Acquired Condition, Fall, Mobility Limitation
- Being tested
- Bedside Bike
- Keywords
- Immobility Harm, Hospital-Acquired Disability, Falls, Deconditioning, In-bed exercise
- Medical subject headings
- Venous Thrombosis, Delirium, Iatrogenic Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside BikeDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bedside Bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From hospital admission to discharge, approximately 5-7 days on average
Secondary outcomes (21)
Change in AM-PAC 6-Clicks Mobility Score
Change in Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" Basic Mobility Inpatient Short Form score from baseline to discharge. Target: improvement of ≥2 points. Score range 6-24, with higher scores indicating better mobility function.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in AM-PAC 6-Clicks Activities of Daily Living Score
Change in Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" Activities of Daily Living (ADL) Inpatient Short Form score from baseline to discharge. Score range 6-24, with higher scores indicating better ADL function.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Discharge Disposition to Home
Percentage of participants discharged directly home (versus inpatient rehabilitation facility, skilled nursing facility, long-term acute care hospital, or death). Target: increase of ≥7% compared to 2025 unit-specific historical rate.
Measured: At hospital discharge, approximately 5-7 days after admission
Incidence of Hospital-Acquired Weakness
Percentage of participants with hospital-acquired weakness defined as Medical Research Council (MRC) sum score <48 at discharge. MRC sum score assesses strength in 12 muscle groups bilaterally (range 0-60), with scores <48 indicating clinically significant weakness. Target incidence: <30%.
Measured: At hospital discharge, approximately 5-7 days after admission
New Institutionalization at 60 Days Post-Discharge
Percentage of participants requiring new placement in skilled nursing facility, long-term care facility, or inpatient rehabilitation facility at 60 days post-discharge (among those discharged home initially).
Measured: 60 days post-hospital discharge
Change in One-Minute Sit-to-Stand Repetitions
Change in number of sit-to-stand repetitions completed in one minute from baseline to discharge. This test measures lower extremity strength and functional capacity.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Six-Minute Walk Test Distance
Change in distance walked in six minutes from baseline to discharge, measured in meters. This test assesses cardiorespiratory fitness and functional exercise capacity.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in EQ-5D Quality of Life Score
Change in EQ-5D (EuroQol 5-Dimension) health-related quality of life score from baseline to discharge. The EQ-5D assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Hospital Anxiety and Depression Scale (HADS)
Change in HADS total score from baseline to discharge. HADS consists of anxiety and depression subscales (each 0-21, total 0-42), with higher scores indicating greater symptom severity.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Berg Balance Scale Score
Change in Berg Balance Scale score from baseline to discharge. Scale ranges 0-56, with higher scores indicating better balance. Scores <45 indicate higher fall risk.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Timed Up and Go Test Duration
Change in time (seconds) required to stand from a chair, walk 3 meters, turn around, walk back, and sit down from baseline to discharge. Shorter times indicate better functional mobility.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Quadriceps Isometric Strength
Change in quadriceps muscle strength measured via handheld dynamometry from baseline to discharge, measured in kilograms of force or Newtons.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Johns Hopkins Highest Level of Mobility (JH-HLM) Score
Change in JH-HLM score from baseline to discharge. Scale ranges 1-8, with higher scores indicating greater mobility independence (1=lying in bed to 8=ambulating >250 feet).
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Estimated VO2 Max
Change in estimated maximal oxygen consumption (VO2 max) from baseline to discharge, measured in mL/kg/min. VO2 max indicates cardiorespiratory fitness.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Braden Skin Score
Change in Braden Scale for Predicting Pressure Sore Risk from baseline to discharge. Scale ranges 6-23, with lower scores indicating higher risk for pressure ulcer development.
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Morse Fall Scale Score
Change in Morse Fall Scale score from baseline to discharge. Scale ranges 0-125, with higher scores indicating greater fall risk (0-24=low risk, 25-50=moderate risk, ≥51=high risk).
Measured: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
60-Day Hospital Readmission Rate
Percentage of participants readmitted to any hospital within 60 days of discharge from index hospitalization, assessed via medical record review.
Measured: 60 days post-hospital discharge
Incidence of Falls Within 60 Days Post-Discharge
Number and percentage of participants experiencing one or more falls after hospital discharge, occurring in any setting (home, post-acute care facility, or community), assessed via medical record review and telephone follow-up.
Measured: 60 days post-hospital discharge
60-Day All-Cause Mortality
All-cause mortality within 60 days of hospital discharge, assessed via medical record review and telephone follow-up.
Measured: 60 days post-hospital discharge
Living Setting at 60 Days Post-Discharge
Participant's living arrangement at 60 days post-discharge, categorized as: home (independent), home (with assistance), skilled nursing facility, long-term care facility, inpatient rehabilitation, other, or deceased.
Measured: 60 days post-hospital discharge
Total Healthcare Costs Through 60 Days
Total direct healthcare costs including index hospitalization and all healthcare utilization within 60 days post-discharge, obtained from de-identified aggregated claims data. Costs measured in US dollars.
Measured: From hospital admission through 60 days post-discharge (approximately 65-75 days total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start5 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Unable to open up the site for recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Immobility SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babar Khan, MD, MS, Indiana University
- Investigators
- Chris Gales, DPT, Principal investigator, Indiana UniversityBabar Khan, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281638
- Sponsor's protocol ID
- 28224
- Acronym
- BB-STEP
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31479364Brown 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.
PubMed 15271112Brown 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.
PubMed 19682121Pasina 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.
PubMed 29121542Cao 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.
PubMed 31995622Yang 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.
PubMed 23827625English 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.
PubMed 19898232Krumholz 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.
PubMed 23301730Drummond 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.
PubMed 22338078Chizhikov 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.
PubMed 15215291Jencks 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.
PubMed 19339721Heit 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.
PubMed 11702898Heit 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.
PubMed 12038942Cohen 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.
PubMed 18242412Zhan 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.
PubMed 14532315
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Bike Early Mobilization Program for Inpatients
- ClinicalTrials.gov ID
- NCT07281638
- Acronym / sponsor ID
- BB-STEP / 28224
- Conditions
- Immobility Syndrome, Deep Venous Thrombosis, Delirium, Hospital Acquired Condition, Fall, Mobility Limitation
- Keywords
- Immobility Harm, Hospital-Acquired Disability, Falls, Deconditioning, In-bed exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to open up the site for recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (receiving Bedside Bike + Usual Care) | Experimental | Device: Bedside BikeAll 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside BikeThe 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. | Device | Intervention Group (receiving Bedside Bike + Usual Care) |
Primary outcome
Device Utilization Feasibility
Time frame: First 5 hospital days (or until discharge if sooner)
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.
Incidence of Device-Related Adverse Events
Time frame: From enrollment through hospital discharge, approximately 5-7 days on average
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.
Hospital Length of Stay
Time frame: From hospital admission to discharge, approximately 5-7 days on average
Duration of index hospitalization in days, compared to 2025 unit-specific median length of stay. Target: reduction of ≥0.2 days versus historical benchmark.
21 secondary outcomes
Change in AM-PAC 6-Clicks Mobility Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in AM-PAC 6-Clicks Activities of Daily Living Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Discharge Disposition to Home
Time frame: At hospital discharge, approximately 5-7 days after admission
Incidence of Hospital-Acquired Weakness
Time frame: At hospital discharge, approximately 5-7 days after admission
New Institutionalization at 60 Days Post-Discharge
Time frame: 60 days post-hospital discharge
Change in One-Minute Sit-to-Stand Repetitions
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Six-Minute Walk Test Distance
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in EQ-5D Quality of Life Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Berg Balance Scale Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Timed Up and Go Test Duration
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Quadriceps Isometric Strength
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Johns Hopkins Highest Level of Mobility (JH-HLM) Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Estimated VO2 Max
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Braden Skin Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
Change in Morse Fall Scale Score
Time frame: Baseline (within 24 hours of admission) to discharge (approximately 5-7 days)
60-Day Hospital Readmission Rate
Time frame: 60 days post-hospital discharge
Incidence of Falls Within 60 Days Post-Discharge
Time frame: 60 days post-hospital discharge
60-Day All-Cause Mortality
Time frame: 60 days post-hospital discharge
Living Setting at 60 Days Post-Discharge
Time frame: 60 days post-hospital discharge
Total Healthcare Costs Through 60 Days
Time frame: From hospital admission through 60 days post-discharge (approximately 65-75 days total)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 31479364Regenbogen 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.
- Background: PubMed 15271112Brown 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.
- Background: PubMed 19682121Brown 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.
- Background: PubMed 29121542Pasina 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.
- Background: PubMed 31995622Cao 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.
- Background: PubMed 23827625Yang 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.
- Background: PubMed 19898232English 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.
- Background: PubMed 23301730Krumholz 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.
- Background: PubMed 22338078Drummond 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.
- Background: PubMed 15215291Chizhikov 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.
- Background: PubMed 19339721Jencks 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.
- Background: PubMed 11702898Heit 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.
- Individual participant dataSharing planned: No
Related trials for Immobility Syndrome
Active, not recruiting
Mechanisms of Disuse Atrophy in Human Skeletal Muscle (iMOB)
Muscular Atrophy, Immobility Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Gales, DPT principal investigator
Indiana University
Babar Khan, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Bedside Bike in people with Immobility Syndrome and Deep Venous Thrombosis, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Utilization Feasibility (time frame: First 5 hospital days (or until discharge if sooner)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07281638, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.