[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659927":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":61,"studyPopulation":52,"armGroups":62,"interventions":80,"overallOfficials":91,"centralContacts":52,"locations":95,"responsibleParty":129,"collaborators":131,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":52,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":52,"enrollmentInfo":147,"targetDuration":52,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":160,"overallStatus":171,"whyStopped":52,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Usual Gait Speed","Gait speed will be measured in meters\u002Fsecond using the time it takes to walk a 4-meter path at usual speed using a stopwatch. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher gait speed indicates better outcome.","Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days",[14,18,22,25,29,32,36,40,43,46,49],{"measure":15,"description":16,"timeFrame":17},"Feasibility of Intervention Measure (FIM)","Feasibility of Intervention (FIM) will be collected from SNF Providers to assess feasibility. The FIM is a 4-item survey rated on a 5-point Likert scale (1=completely disagree to 5=completely agree), with higher average scores indicating greater feasibility.","At end of STAMP phase, approximately 8 months",{"measure":19,"description":20,"timeFrame":21},"STAMP Session Adherence Rate","Of all enrolled patients, percent completing ≥ 80% of sessions attempted by mobility aide","Beginning of STAMP phase to end of STAMP phase, approximately 8 months",{"measure":23,"description":24,"timeFrame":12},"Modified 30 Second Sit to Stand","The Modified 30 second sit to stand test (m30STS) counts the number of stands from a chair completed in 30 seconds, which allows for upper extremity use on the armrests of a chair. The score is the total number of stands completed in 30 seconds; more than halfway up at the end of 30 seconds counts as a stand. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher scores indicate better outcomes.",{"measure":26,"description":27,"timeFrame":28},"Number of Rehospitalizations","Number of re-hospitalizations during SNF stay.","Up to 8 months of Pre-STAMP phase and 8 months of STAMP phase",{"measure":30,"description":31,"timeFrame":21},"STAMP Intervention Fidelity","Percent of mobility aides achieving an average of ≥80% fidelity across study assessments. A formally trained site champion or research team member will measure STAMP fidelity on at least 2 patients per mobility aide each quarter.",{"measure":33,"description":34,"timeFrame":35},"Theoretical Framework of Acceptability (TFA)","Theoretical Framework of Acceptability (TFA) will be collected from SNF Providers to assess acceptability of the STAMP intervention. The TFA is a survey, which includes 8 items rated 1-5 on a Likert scale and summed (higher scores indicate greater acceptability).","At month 8 of STAMP phase",{"measure":37,"description":38,"timeFrame":39},"Pittsburgh Rehabilitation Participation Scale (PRPS)","Patient acceptability of the STAMP intervention will be assessed by mobility aides using the PRPS. The PRPS is a validated, single question, 6-point Likert-scale, rated by the mobility aide, that measures effort and participation. Higher score indicates more acceptability.","Every patient encounter during STAMP phase",{"measure":41,"description":42,"timeFrame":12},"Change in Step Count","Change in daily step count from admission to discharge.",{"measure":44,"description":45,"timeFrame":12},"Proportion of Patients with Increased Step Count","Of all enrolled patients, proportion achieving ≥20% increase in daily step count from admission to discharge.",{"measure":47,"description":48,"timeFrame":12},"Change in Short Physical Performance Battery (SPPB)","The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance. Completion rates and within site pre- to post-STAMP differences will be assessed.",{"measure":50,"description":51,"timeFrame":12},"Change in Modified Barthel ADL Index (MBI)","The MBI assesses the ability to perform basic Activities of Daily Living (ADL) tasks. Total score range is 0-100. Total score is commuted by summing dependence across 10 ADL tasks: chair\u002Fbed transfers, ambulation, stair climbing, toilet transfers, bowel control, bladder control, bathing, dressing, personal hygiene (grooming), and feeding. Higher scores indicate increased independence. Completion rates and within site pre- to post-STAMP differences will be assessed.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"NON_RANDOMIZED","PARALLEL","The study model uses pretest-posttest design, with each facility serving as its own control. Two facilities will go through a pre-STAMP phase and a STAMP phase, creating four conditions.","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":52},"NONE","Investigators will not be blinded to the arms due to facility\u002Fclinician training required for this study design. Each study site \\[i.e., skilled nursing facility (SNFs)\\] will serve as its own control in a pretest-posttest design. As such, clinicians, mobility aides, and nursing staff will remain blinded to the intervention during the first phase of the trial until trained on the intervention. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.","A substantial portion of older adults receiving care in skilled nursing facilities (SNFs) do not achieve successful outcomes, with nearly 40% unable to return home and up to 29% experiencing hospital readmission an outcome strongly associated with mortality. A major, modifiable contributor to these poor outcomes is reduced physical function. Although SNFs offer structured rehabilitation to address mobility impairments, its effectiveness is undermined by pervasive sedentary behavior. Up to 96% of patients receiving care in SNFs require assistance with mobility, and despite participating in daily rehabilitation, patients average less than 1,000 steps per day.\n\nOur team conducted an NIH-funded pragmatic cluster randomized trial (R01, AG072693) evaluating high-intensity rehabilitation (HIR) to improve functional recovery. This trial provided a strong foundation and highlighted that high-intensity rehabilitation alone may be insufficient if patients remain inactive outside of scheduled sessions.\n\nThe purpose of this study is to determine the feasibility of an interdisciplinary, patient-centered mobility program (STAMP) to address common barriers in SNFs (e.g., staff shortages, safety concerns, limited training) and increase daily activity with support from a mobility aide. This aide will support patients in walking and functional transfers outside of formal therapy sessions, targeting 45 minutes of additional physical activity to complement structured rehabilitation. This study will explore whether STAMP alone or in combination with HIR offers a scalable strategy to improve function. The study will evaluate STAMP implemented in two settings: one with HIR + STAMP and one with usual care + STAMP. Investigators will determine feasibility, acceptability, and safety of STAMP through a convergent parallel mixed methods approach. Secondarily, investigators will evaluate the feasibility and variability of patient physical function outcome measures to inform outcome selection for future trials.",[63,68,73,77],{"label":64,"type":65,"description":52,"interventionNames":66},"Usual Care","ACTIVE_COMPARATOR",[67],"Other: Usual Care",{"label":69,"type":70,"description":52,"interventionNames":71},"High Intensity Rehabilitation","EXPERIMENTAL",[72],"Other: High Intensity Rehabilitation",{"label":74,"type":70,"description":52,"interventionNames":75},"Usual Care and STAMP",[76,67],"Other: Safe Transfers and Mobility Program",{"label":78,"type":70,"description":52,"interventionNames":79},"High Intensity Rehabilitation and STAMP",[72,76],[81,84,88],{"type":6,"name":69,"description":82,"armGroupLabels":83,"otherNames":52},"An 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Activities will include strength training, transfer practice, balance training, advanced ADLs. Clinicians will tailor the intervention for each activity to target overload using 8-repetition maximum for resistance training. Other interventions will be performed to muscle failure or inability to complete the final repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy.",[69,78],{"type":6,"name":85,"description":86,"armGroupLabels":87,"otherNames":52},"Safe Transfers and Mobility Program","The Safe Transfers and Mobility Program (STAMP) embeds a mobility aide into daily care. STAMP is a patient-centered, scalable approach to extend the benefits of rehabilitation sessions by increasing mobility throughout the day and reinforcing activity between therapy sessions. Core components are: (1) targeting 45 minutes of additional daily physical activity through support with walking and functional mobility tasks; (2) establishing individualized mobility goals collaboratively set by the therapist and patient, based on functional level; (3) delivering progressive activities with walking distances increased by \\~30% weekly, adjusted for patient tolerance; and (4) interdisciplinary coordination to incorporate STAMP sessions into routine care with minimal disruption to clinical workflow. Prior work suggests that 45 minutes of STAMP can at least double daily step counts, and increasing walking distance by 30% per week is feasible even for individuals with low baseline function.",[78,74],{"type":6,"name":64,"description":89,"armGroupLabels":90,"otherNames":52},"Usual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials.",[64,74],[92],{"name":93,"affiliation":5,"role":94},"Jennifer Stevens-Lapsley, PT, PhD","PRINCIPAL_INVESTIGATOR",[96,114],{"facility":97,"status":52,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"University of Colorado Denver, Anschutz Medical Campus","Aurora","Colorado","80045","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-104.83192,39.72943,{"lat":107,"lon":106},[110],{"name":93,"role":111,"phone":112,"phoneExt":52,"email":113},"CONTACT","303-724-9590","jennifer.stevens-lapsley@cuanschutz.edu",{"facility":115,"status":52,"city":116,"state":117,"zip":118,"country":101,"countryCode":102,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Aegis Therapies","Frisco","Texas","75034",{"type":104,"coordinates":120},[121,122],-96.82361,33.15067,{"lat":122,"lon":121},[125],{"name":126,"role":111,"phone":127,"phoneExt":52,"email":128},"Dawn Greaves","317-513-9116","Dawn.Greaves@aegistherapies.com",{"type":130,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[132,135],{"name":133,"class":134},"National Institute on Aging (NIA)","NIH",{"name":136,"class":137},"Aegis Therapies, Inc.","INDUSTRY","100659927","supplemental-mobility-100659927",false,"NCT07872384","Supplemental Mobility","Improving Functional Recovery in Skilled Nursing Facilities Through Supplemental Mobility","Inclusion Criteria:\n\n* At least 50 years old\n* Admitted to SNF from the hospital\n* Ambulatory at admission with minimal assistance or less\n\nExclusion Criteria:\n\n* Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)\n* Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)\n* Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation\n* Subsequent SNF admission","ALL","50 Years",{"count":148,"type":149},192,"ESTIMATED","INTERVENTIONAL",[152],"NA","This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. STAMP will be administered by a mobility aide who will support patients in increasing physical activity through walking and transfers outside of structured rehabilitation. Participants will either receive high-intensity rehabilitation (HIR) or usual care rehabilitation, combined with STAMP. The two main aims are: 1) determine the feasibility, acceptability, and safety of STAMP, and 2) evaluate the feasibility and variability of patient physical function outcome measures. The study will provide preliminary data on program delivery and safety to inform the design of a larger trial aimed at identifying the most effective strategies to optimize functional recovery in SNFs.",[155,156,157,158,159],"Aging","Functional Recovery","Skilled Nursing Facility","Medically Complex","Deconditioning",[161,162,163,164,165,166,167,168,85,169,170],"Rehabilitation","Older Adults","Physical Therapy","Occupational Therapy","i-STRONGER","High-Intensity Rehabilitation","Post-Acute Care","Physical Function","Feasibility","Implementation Science","NOT_YET_RECRUITING","2026-10-08",{"date":174,"type":175},"2026-10-13","ACTUAL",{"date":177,"type":149},"2026-09",{"date":179,"type":149},"2028-05",{"name":5,"class":6},2]