NCT02927171

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

September 26, 2016

Results QC Date

March 20, 2020

Last Update Submit

March 20, 2020

Conditions

Keywords

Skilled Nursing FacilityPost-Acute CareOlder AdultsPhysical FunctionRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    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.

    Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)

Secondary Outcomes (1)

  • Gait Speed

    Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)

Other Outcomes (1)

  • Patient Satisfaction Survey

    Quantification at SNF Discharge (Expected average length of stay: 21 days)

Study Arms (2)

Usual Care

NO INTERVENTION

Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.

I-STRONGER

EXPERIMENTAL

IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.

Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents

Interventions

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

Also known as: I-STRONGER
I-STRONGER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 years of age who are admitted to a skilled nursing facility following hospitalization
  • Qualify to receive at least physical therapy services

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

VA Community Living Center

Aurora, Colorado, 80045, United States

Location

Brookdale Senior Living

Denver, Colorado, 80247, United States

Location

Related Publications (2)

  • Mallinson T, Deutsch A, Bateman J, Tseng HY, Manheim L, Almagor O, Heinemann AW. Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair. Arch Phys Med Rehabil. 2014 Feb;95(2):209-17. doi: 10.1016/j.apmr.2013.05.031. Epub 2013 Jul 10.

  • Peterson MJ, Crowley GM, Sullivan RJ, Morey MC. Physical function in sedentary and exercising older veterans as compared to national norms. J Rehabil Res Dev. 2004 Sep;41(5):653-8. doi: 10.1682/jrrd.2003.09.0141.

Results Point of Contact

Title
Dr. Jennifer Stevens-Lapsley
Organization
University of Colorado Denver

Study Officials

  • Jennifer E. Stevens-Lapsley, PhD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 6, 2016

Study Start

February 28, 2016

Primary Completion

October 30, 2018

Study Completion

January 1, 2019

Last Updated

April 3, 2020

Results First Posted

April 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations