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Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Aging
Medically Complex
Deconditioning
Functional Recovery
Skilled Nursing Facility

Treatments

Other: Usual Care
Other: i-STRONGER

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05492240
20-3068
R01AG072693 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

In the U.S., 8.37 million adults over 65 will experience a hospital stay over the next year, which often has serious and long-lasting consequences including profound deterioration in physical function. Following a hospital stay, around 1.35 million patients with deconditioning require rehabilitation in a skilled nursing facility (SNF) each year to address the deleterious musculoskeletal and functional deficits from deconditioning. More than 64% of patients discharge from SNFs at functional levels that predispose them to adverse events, including rehospitalization, failing health, disability, institutionalization, or death. Physical function is a known modifiable predictor of these deleterious events, which can be addressed with rehabilitation. Therefore, more progressive and targeted musculoskeletal rehabilitation strategies that optimize physical function more effectively are needed.

Therefore, the purpose of this study is to determine the effectiveness of a high-intensity rehabilitation approach (also referred to as i-STRONGER) at multiple skilled nursing facilities (SNFs), while evaluating characteristics of successful implementation through a rigorous, pragmatic cluster randomized controlled trial (16 Intervention SNFs vs 16 Usual Care SNFs). The investigators will promote high-intensity rehabilitation delivery to patients in an effort to address poor physical function outcomes. Specifically, the investigators will train rehabilitation clinicians at Intervention sites using distance-based instruction and collect study outcomes via the electronic medical record. Additionally, the investigators will gather quantitative and qualitative data (mixed methods) to evaluate processes, clinician-specific characteristics, and facility-specific contexts of implementation. The study methods seek to maximize successful reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) across Intervention sites. The implementation strategy is informed by the RE-AIM framework and integrated with educational and behavioral theories to facilitate clinical adoption of high-intensity rehabilitation.

Enrollment

4,383 patients

Sex

All

Ages

50 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Rehabilitation staff at enrolled sites will participate in research activities, as indicated by group assignment.

Site Inclusion Criteria:

  • Aegis Therapies-contracted skilled nursing facility (SNF)
  • Admits approximately 15 patients per month for short term rehabilitation

Patient Inclusion Criteria:

  • At least 50 years of age
  • Admitted to a SNF from the hospital
  • Ambulatory upon SNF admission

Patient Exclusion Criteria:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4,383 participants in 2 patient groups

i-STRONGER
Experimental group
Description:
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.
Treatment:
Other: i-STRONGER
Usual Care
Active Comparator group
Description:
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.
Treatment:
Other: Usual Care

Trial contacts and locations

2

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Central trial contact

Maggie Givan, MA

Data sourced from clinicaltrials.gov

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