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i-STRONGER for Functional Recovery in Aging

N/A
Recruiting
Led By Jennifer Stevens-Lapsley, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aegis Therapies-contracted skilled nursing facility (SNF)
Admits approximately 15 patients per month for short term rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from 16 months up to 22 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test whether high-intensity rehabilitation can improve outcomes for patients in skilled nursing facilities. It will also explore what predicts success in implementing this rehabilitation.

Who is the study for?
This trial is for adults aged 50 or older who can walk when they enter a skilled nursing facility (SNF) from the hospital. They must be in an SNF that works with Aegis Therapies and sees about 15 patients a month for short-term rehab. People with weight-bearing issues, multiple SNF stays, contraindications to intense exercise, or neurological conditions like stroke or Parkinson's cannot join.Check my eligibility
What is being tested?
The study compares high-intensity rehabilitation called i-STRONGER against usual care in improving recovery for older adults after hospitalization. It's set up so different facilities are randomly chosen to use either the new approach or stick with standard treatment.See study design
What are the potential side effects?
Since this trial involves high-intensity physical training, potential side effects may include muscle soreness, fatigue, and increased risk of falls or injuries related to exercise. The specific risks will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am staying at a skilled nursing facility contracted with Aegis Therapies.
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My facility admits around 15 patients monthly for short-term rehab.
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I am 50 years old or older.
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I was admitted to a skilled nursing facility from the hospital.
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I was able to walk when I was admitted to the nursing facility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from 16 months up to 22 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from 16 months up to 22 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gait
Secondary outcome measures
Change in Short Physical Performance Battery (SPPB)
Post-discharge Rehospitalization Rate
Other outcome measures
Change in Total Score Modified Barthel ADL Index (MBI)
RE-AIM Component: Adoption
RE-AIM Component: Implementation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: i-STRONGERExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,711 Previous Clinical Trials
1,926,834 Total Patients Enrolled
Aegis Therapies, Inc.UNKNOWN
National Institute on Aging (NIA)NIH
1,644 Previous Clinical Trials
28,000,153 Total Patients Enrolled

Media Library

i-STRONGER Clinical Trial Eligibility Overview. Trial Name: NCT05492240 — N/A
Functional Recovery Research Study Groups: i-STRONGER, Usual Care
Functional Recovery Clinical Trial 2023: i-STRONGER Highlights & Side Effects. Trial Name: NCT05492240 — N/A
i-STRONGER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492240 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial open to those younger than fifty years old?

"Patients aged between 50 and 120 years old may participate in this medical trial."

Answered by AI

Who is eligible to partake in this clinical exploration?

"This clinical trial is inviting 2880 people with functional recovery to take part, provided they fall within the age range of 50 and 120. Those who qualify should meet specific requirements: involvement in rehabilitation staff research activities as indicated by group assignment; being a patient at an Aegis Therapies-contracted skilled nursing facility that admits around 15 individuals per month for short term rehab; ambulatory upon admission to said SNF; and at least fifty years old when admitted from hospital."

Answered by AI

What is the upper limit of participants for this research endeavor?

"Affirmative. Evidenced by clinicaltrials.gov, this research project is actively endeavouring to source 2880 participants between two sites. It was originally advertised on July 24th 2022 and the last update was made on August 4th 2022."

Answered by AI

Is this experiment actively recruiting participants?

"Affirmative. The clinical trials website indicates that this research is actively seeking out volunteers, which was initially posted on July 24th 2022 and updated lastly on August 4th of the same year. In total, 2880 individuals need to be recruited between two sites."

Answered by AI
~1115 spots leftby Feb 2025