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Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

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ClinicalTrials.gov Identifier: NCT02927171
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Physical Deconditioning Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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 Name: I-STRONGER




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Barthel Index of Activities of Daily Living [ Time Frame: Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days) ]
    Index assesses the ability to perform basic activities of daily living ADL tasks such as bowels & bladder control, grooming, toilet use, feeding, transfers, mobility, dressing, stairs, and bathing.


Other Outcome Measures:
  1. 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)

  2. Saint Louis University Mental Status Exam (SLUMS) [ Time Frame: Quantification at SNF Admission (baseline/initial evaluation) ]
    SLUMS screens for cognitive impairments by assessing participant function in the areas of attention, calculation, immediate and delayed recall, animal naming, and visuospatial skills



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older adults > 55 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927171


Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
VA Community Living Center
Aurora, Colorado, United States, 80045
Brookdale Senior Living
Denver, Colorado, United States, 80247
Sponsors and Collaborators
VA Office of Research and Development
University of Colorado, Denver
Investigators
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Principal Investigator: Jennifer E. Stevens-Lapsley, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02927171     History of Changes
Other Study ID Numbers: E2193-P
I21RX002193 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Skilled Nursing Facility
Post-Acute Care
Older Adults
Physical Function
Rehabilitation