Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Physical Deconditioning Clinical Trial

Official title:

Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927171
• Other study ID #: E2193-P
• Secondary ID: I21RX002193
• Status: Completed
• Phase: N/A
• Start date: February 28, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 1, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Deconditioning

Intervention

Other:
• IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Ar — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Survey	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)
Primary	Short Physical Performance Battery (SPPB)	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	Gait Speed	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)