Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Conditions
-----------------
Physical Deconditioning

Intervention / Treatment
-----------------
* Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 years of age who are admitted to a skilled nursing facility following hospitalization Qualify to receive at least physical therapy services 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: Parkinson's Disease Traumatic Brain Injury Recent Cerebral Vascular Accident Alzheimer's Disease 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): Recent unstable fracture Advanced congestive heart failure Bone metastasis sites Tumors in strengthening target areas Acute Illness Recent myocardial infarction (within 3-6 weeks) Weight bearing restrictions on graft or fracture sites Exposed tendon or muscle Absence of pedal pulses Presence of fistula Platelet levels <50,000/ L

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care. | |
| Experimental: I-STRONGER<br>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. | Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents<br>* Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.<br>* Other names: I-STRONGER;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-Acute Care, Older Adults, Physical Function, Rehabilitation, Skilled Nursing Facility