Title {1}	Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients (AMBULATE): Study Protocol for a Randomized Controlled Trial
Trial registration {2a and 2b}.	Registered in the United States National Library of Medicine clinicaltrials.gov (# NCT05725928).
Protocol version {3}	1.0
Funding {4}	This study is funded by the National Institute on Aging (1R01AG073278-01A1).
Author details {5a}	Joshua K. Johnson1,2, Aaron C. Hamilton3, Bo Hu4, Quinn R. Pack5, Peter K. Lindenauer5, Robert J. Fox6, Ardeshir Hashmi7, Lee Anne Siegmund8, Christian N. Burchill9, Glen B. Taksler2,4,10, Toyomi Goto2, Mary Stilphen11, Michael B. Rothberg2 1. Department of Physical Medicine and Rehabilitation, Neurological Institute, Cleveland Clinic, Cleveland, OH 2. Center for Value-Based Care Research, Cleveland Clinic, Cleveland, OH 3. Department of Hospital Medicine, Cleveland Clinic, Cleveland, OH 4. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH 5. Department of Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield 6. Mellen Center for Treatment and Research in Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, OH 7. Center for Geriatric Medicine, Cleveland Clinic, Cleveland, Ohio 8. Office of Nursing Research and Innovation, and Consultant Staff, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 9. Penn Medicine Lancaster General Hospital, Lancaster, PA 10. Population Health Research Institute, Case Western Reserve University at MetroHealth System, Cleveland, OH 11. Rehabilitation and Sports Therapy, Neurological Institute, Cleveland Clinic, Cleveland, OH
Name and contact information for the trial sponsor {5b}	Trial sponsor: National Institute on Aging Contact Name: Barbara Radziszewska (Program Official) Address: PO Box 8057, Gaithersburg, MD 20898 Phone: 800-222-2225 Email: radziszb@mail.nih.gov
Role of sponsor {5c}	NIA will monitor progress of the study and will convene the Data Safety Monitoring Board (DSMB). The PI will provide NIA with interval reports of study progress with enrollment, dropouts and safety events. If there are unexpected delays, NIA may offer advice or support. NIA will convene the DSMB and ensure it has regular meetings as determined by their charter. Data will be provided to the DSMB by the study statistician. NIA may stop the study at any point if it determines there are serious safety concerns or for evidence of futility. The study statistician will prepare an analysis for futility once 40% of the patients have reached Time 2.