Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Not Applicable

Completed

• Conditions: Physical Deconditioning
• Interventions: Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents

• Registration Number: NCT02927171
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study Start: 2016-02-28
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2018-10-30
• Study Completion: 2019-01-01
• Status Verified: 2020-03
• Results First Submitted: 2020-03-20
• Results First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-20
• Results First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I-STRONGER	IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents	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.

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	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.

Secondary Outcome Measures

Name	Time	Method
Gait Speed	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.

Trial Locations

Locations (3)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States

VA Community Living Center; 🇺🇸 Aurora, Colorado, United States

Brookdale Senior Living; 🇺🇸 Denver, Colorado, United States