Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

NCT05492240 | Completed DMC

• 2 other identifiers: 20-3068R01AG072693
• Study Type: interventional
• Target: 4,383
• Locations: 1 country
• Sites: 2

Brief Summary

This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.

Conditions

Aging; Skilled Nursing Facility; Medically Complex; Deconditioning; Functional Recovery

Keywords

Rehabilitation; Older Adults; Physical Therapy; Occupational Therapy; RE-AIM; i-STRONGER; High-intensity Rehabilitation; Implementation Science; Post-Acute Care; Physical Function

Outcome Measures

Primary Outcomes (1)

• Change in Gait Speed

  Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch.

  From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days

Secondary Outcomes (2)

• Change in Short Physical Performance Battery (SPPB)

  From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days

• Post-discharge Rehospitalization Rate

  From date of discharge from the SNF, assessed up to 30 days

Other Outcomes (5)

• Change in Total Score Modified Barthel ADL Index (MBI)

  From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days

• RE-AIM Component: Reach

  Up to 16 months

• RE-AIM Component: Adoption

  Up to 16 months

Study Arms (2)

i-STRONGER

EXPERIMENTAL

The high-intensity rehabilitation intervention, termed i-STRONGER, relies on principles of physiologic overload using an 8-repetition max (8RM) to promote muscle strengthening and emphasizes functional carryover for independence.

Other: i-STRONGER

Usual Care

ACTIVE COMPARATOR

The Usual Care SNFs will continue clinical practice as normal, and sites will not have any overlap of personnel or training with i-STRONGER SNFs.

Other: Usual Care

Interventions

i-STRONGER OTHER

An 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Clinicians will tailor the intervention for each activity, so the patient achieves 8 repetitions with failure on the 9th repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy.

i-STRONGER

Usual Care OTHER

Usual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Furthermore, a combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials.

Usual Care

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aegis Therapies-contracted skilled nursing facility (SNF)
• Admits approximately 15 patients per month for short term rehabilitation
• At least 50 years of age
• Admitted to a SNF from the hospital
• Ambulatory upon SNF admission

You may not qualify if:

• Contraindications to high-intensity resistance training, per American College of Sports Medicine Exercise Testing and Prescription
• Lower extremity weight-bearing precautions
• Neurological diagnosis (e.g., Cerebral vascular accident, Multiple Sclerosis, Parkinson's disease)
• Subsequent SNF admission

Sponsors & Collaborators

• Aegis Therapies, Inc.: collaborator
• National Institute on Aging (NIA): collaborator
• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Aegis Therapies

Frisco, Texas, 75034, United States

Location

Study Officials

• Jennifer Stevens-Lapsley, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigators will not be blinded to the arms due to facility/clinician training required for this study design. Study sites \[i.e., skilled nursing facilities (SNFs)\] will be the unit of randomization. SNF study sites will be made broadly aware of the study initiative during the site recruitment process; however, the site will not be provided with detailed information about the intervention unless randomized to the Intervention arm. As such, clinicians, or rehabilitation care providers, at usual care sites will remain blinded to the intervention for the duration of the study. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 8, 2022
• Study Start: July 24, 2022
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available starting 6 months after primary study publication and ending 2 1/2 years after publication.
• Access Criteria: Data will be made available upon reasonable written request to the study team. The PI, Dr. Jennifer Stevens-Lapsley will review requests.

Locations

US (2)