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
| Type | Name | Description |
|---|---|---|
| OTHER | IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents | Progressive, 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.