Skip to main content
OpenTrials
Completed

NCT Number: NCT02927171

Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 18 years of age who are admitted to a skilled nursing facility following hospitalization
  • 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

Treatment and study plan

IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents

Other

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

Other names: I-STRONGER

Primary outcomes

  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. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.

Secondary outcomes

  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. Lower scores indicate better function.

Other outcomes

  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). Higher scores indicate higher satisfaction.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Colorado, Denver

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.