Clinical Trials Directory

Trials / Completed

CompletedNCT02927171

Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
104 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERIntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home ResidentsProgressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Timeline

Start date
2016-02-28
Primary completion
2018-10-30
Completion
2019-01-01
First posted
2016-10-06
Last updated
2020-04-03
Results posted
2020-04-03

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02927171. Inclusion in this directory is not an endorsement.