Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-28

Study Completion Date

2019-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Physical Deconditioning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care

Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents

Intervention Type OTHER

Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Interventions

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IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents

Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Intervention Type OTHER

Other Intervention Names

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I-STRONGER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No