Clinical trial NCT02927171: Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Official title: Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Deconditioning
Keywords: Skilled Nursing Facility
Post-Acute Care
Older Adults
Physical Function
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
First posted: 2016-10-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adults \> 18 years of age who are admitted to a skilled nursing facility following hospitalization
2. 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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Secondary outcomes:
measure: Gait Speed
timeFrame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
Other outcomes:
measure: Patient Satisfaction Survey
timeFrame: Quantification at SNF Discharge (Expected average length of stay: 21 days)
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Aurora
country: United States
facility: VA Community Living Center
state: Colorado
city: Denver
country: United States
facility: Brookdale Senior Living
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.