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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX002193 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care.
There is growing recognition that acute hospitalization contributes to marked functional decline in older adults. Nearly 20% of all hospitalized older adults are discharged to a skilled nursing facility (SNF) to address these functional deficits. However, rehabilitation in SNFs may not adequately restore physical function, which potentially contributes to poor community discharge rates. Strikingly, only 37% of all patients admitted to SNFs are discharged to a community setting, which suggests a paradigm shift is required to optimize rehabilitation within SNFs. Currently, usual care rehabilitation in SNFs consists of low-intensity rehabilitation interventions, which are physiologically inadequate to induce meaningful changes in skeletal muscle strength and physical function. Therefore, the investigators propose a novel "IntenSive Therapeutic Rehabilitation for Older skilled NursinG HomE Residents" (I-STRONGER) program, which integrates principles of physiologic tissue overload into combined strengthening and functional interventions for greater gains in physical function. The overall goals of this investigation are to 1) demonstrate feasibility of I-STRONGER in SNF settings and 2) determine the effectiveness of I-STRONGER in improving physical function. A comparison of usual care (UC) with I-STRONGER will occur using a staged, 2 group design (independent cohorts), with a single SNF serving as its own control. The first cohort of SNF patients will participate in UC (Stage 1) and after therapist training on ISTRONGER is completed, a second cohort of patients entering the same facility will participate in I-STRONGER (Stage 2). The feasibility of I-STRONGER will be evaluated by patient acceptability and therapist compliance measures. Sample size estimates (using patients with mobility deficits in home health settings) suggest at least 86 participants are necessary to be adequately powered. Heterogeneity of the sample will be re-evaluated during the study period using SNF data and sample size estimates may be adjusted as appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. | |
| I-STRONGER | Experimental | IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents | Other | Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. |
| 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. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function. | Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | Time it takes to walk a 4 meter path. Lower scores indicate better function. | Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey | 8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction. | Quantification at SNF Discharge (Expected average length of stay: 21 days) |
Inclusion Criteria:
Exclusion Criteria:
Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor control approach rather than the proposed high-intensity approach. Such patient populations include:
Patients on hospice care will be excluded as the approach is based on palliative principles.
Other patients to be excluded will include those with conditions where strength training is contraindicated (as indicated by the American College of
Sports Medicine Guidelines for Exercise Testing and Prescription):
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E. Stevens-Lapsley, PhD | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States | ||
| VA Community Living Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23850612 | Result | 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. | |
| 15558394 | Result | Peterson MJ, Crowley GM, Sullivan RJ, Morey MC. Physical function in sedentary and exercising older veterans as compared to national norms. J Rehabil Res Dev. 2004 Sep;41(5):653-8. doi: 10.1682/jrrd.2003.09.0141. |
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There were no exclusions of participants. All eligible, willing participants were allocated to one of two arms.
Participants were recruited from a skilled nursing facility between the dates of 02.28.2016 and 10.30.2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. |
| FG001 | I-STRONGER | IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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1 participant in the I-STRONGER arm was lost to follow-up. They were discharged home early, and discharge outcomes were not assessed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. |
| BG001 | I-STRONGER | IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Physical Performance Battery (SPPB) | Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function. | Posted | Mean | Standard Deviation | score on a scale | Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) |
|
Baseline through discharge from Skilled Nursing Facility (average 21 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Stevens-Lapsley | University of Colorado Denver | 303.724.9170 | jennifer.stevens-lapsley@cuanschutz.edu |
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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 | Dec 6, 2018 | Mar 11, 2020 | Prot_SAP_000.pdf |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Brookdale Senior Living | Denver | Colorado | 80247 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Gait Speed | Time it takes to walk a 4 meter path. Lower scores indicate better function. | Posted | Mean | Standard Deviation | seconds | Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) |
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| Other Pre-specified | Patient Satisfaction Survey | 8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Quantification at SNF Discharge (Expected average length of stay: 21 days) |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | I-STRONGER | IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. | 0 | 50 | 0 | 50 | 0 | 50 |
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