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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from 16 months up to 22 months
Awards & highlights

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.

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

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
1,758 Previous Clinical Trials
2,163,380 Total Patients Enrolled
Aegis Therapies, Inc.UNKNOWN
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,030,377 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
~1061 spots leftby Sep 2025
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