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During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.
HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Rehabilitation plus Mobility (HeRo) | Experimental | The HeRo group will receive a behavior-change intervention based in the principals of behavioral economics to improve mobility. Physical and occupational therapists have been trained to deliver a high-intensity, functional intervention as the standard of care in this skilled nursing facility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Rehabilitation plus Mobility (HeRo) | Other | Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | Time it takes to walk 4 meters (meters per second) | Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests | Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey | 8 question survey on patient satisfaction, scoring each question on a 1-10 scale (1=not at all and 10=extremely) | At date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission). |
| Physical Activity (upright time) |
Inclusion Criteria:
Exclusion Criteria:
Patients with neurological disorders such as acute stroke or acute traumatic brain injury
Patients on hospice care
Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
Weight-bearing precautions and inability to ambulate prior to hospitalization
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Stevens-Lapsley, PT, PhD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Community Living Center at Fitzsimmons | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23850612 | Background | Mallinson T, Deutsch A, Bateman J, Tseng HY, Manheim L, Almagor O, Heinemann AW. Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair. Arch Phys Med Rehabil. 2014 Feb;95(2):209-17. doi: 10.1016/j.apmr.2013.05.031. Epub 2013 Jul 10. | |
| 30056009 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2020 | Jul 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2020 | Jul 11, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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This is a single arm study but will use two historical cohorts as comparison groups to assess outcomes: 1) usual care and 2) high-intensity, functionally based resistance training alone. The historical cohorts were included in a previous study (Clinical Trials Registry identifier: E2193-P). This design will include independent cohorts of patients within a single SNF, using the facility as its own control. This design optimally controls for facility-level variables that vary widely between SNFs and may influence care delivery, such as staffing levels, staff experience, and productivity standards.
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Percent waking hours spent upright measured using ActivPAL devices |
| Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days). |
| Physical Activity (sedentary time) | Time spent in sedentary bouts measured using ActivPAL devices | Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days). |
| Treatment fidelity | Provider intervention compliance with high-intensity rehabilitation (PT and OT) and mobility (nursing staff) using a fidelity checklist | At least 2 observations per provider per year throughout duration of study (approximately 2 years), 2 additional observations scheduled if compliance is <80% on objective fidelity checklist. |
| Simning A, Caprio TV, Seplaki CL, Temkin-Greener H, Szanton SL, Conwell Y. Patient-Reported Outcomes in Functioning Following Nursing Home or Inpatient Rehabilitation. J Am Med Dir Assoc. 2018 Oct;19(10):864-870. doi: 10.1016/j.jamda.2018.06.014. Epub 2018 Jul 25. |
| 20440029 | Background | Grant PM, Granat MH, Thow MK, Maclaren WM. Analyzing free-living physical activity of older adults in different environments using body-worn activity monitors. J Aging Phys Act. 2010 Apr;18(2):171-84. doi: 10.1123/japa.18.2.171. |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |