Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

March 20, 2020 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Aurora, Colorado, United States, 80045
        • VA Community Living Center
      • Denver, Colorado, United States, 80247
        • Brookdale Senior Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)
Time Frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
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 Frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Survey
Time Frame: Quantification at SNF Discharge (Expected average length of stay: 21 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

University of Colorado, Denver

Investigators

  • Principal Investigator: Jennifer E. Stevens-Lapsley, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2016

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2193-P
  • I21RX002193 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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