i-STRONGER for Functional Recovery in Aging

Recruiting at 1 trial location

Overseen By Maggie Givan, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neurological diagnosis, Weight-bearing precautions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

2880 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehabilitation program called i-STRONGER, designed to improve recovery after hospitalization. It emphasizes high-intensity exercises to strengthen muscles and enhance independence for patients in skilled nursing facilities. Participants will either receive this new treatment or continue with their usual care to determine which is more effective. Individuals aged 50 or older, admitted to a skilled nursing facility from a hospital, and able to walk upon admission are suitable candidates for this trial. As an unphased trial, participants contribute to pioneering research that may enhance recovery methods for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this high-intensity rehabilitation is safe for older skilled nursing home residents?

Research shows that the i-STRONGER program, which involves high-intensity strength training, is safe for older adults in nursing homes. Studies have found that this exercise is not only safe but also well-received by older adults with medical conditions. Reports of serious side effects are rare. The training aims to build muscle strength to improve independence in daily activities. Overall, evidence suggests that i-STRONGER is a safe choice for those interested in this type of rehabilitation program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about i-STRONGER because it introduces a high-intensity rehabilitation approach specifically designed for aging individuals to promote muscle strengthening. Unlike standard care, which typically involves routine physical therapy, i-STRONGER uses the principle of physiologic overload with an 8-repetition max (8RM) to effectively enhance strength and independence. This method emphasizes functional carryover, aiming to improve not just muscle power but also daily life activities, potentially offering a more impactful recovery for older adults.

What evidence suggests that i-STRONGER is effective for functional recovery in aging?

Research has shown that high-intensity rehabilitation programs, such as i-STRONGER, can help older adults in nursing homes enhance their physical abilities. One study found that patients using i-STRONGER walked faster, increasing their speed by 0.13 meters per second more than those receiving regular care. Another study demonstrated that high-intensity resistance training was safe and practical, resulting in faster walking and shorter hospital stays. Overall, this type of rehabilitation has produced promising results in aiding recovery after hospitalization. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer E Stevens-Lapsley, PT, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Site Inclusion Criteria: Aegis Therapies-contracted skilled nursing facility (SNF)

I was able to walk when I was admitted to the nursing facility.

I am at least 50 years old.

Exclusion Criteria

I do not have a neurological condition like stroke, MS, or Parkinson's.

Patient Exclusion Criteria: Contraindications to high-intensity resistance training, per American College of Sports Medicine Exercise Testing and Prescription

I do not have restrictions on putting weight on my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-intensity rehabilitation (i-STRONGER) or usual care in skilled nursing facilities

3 weeks

Continuous care during SNF stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rehospitalization rates

4 weeks

1 visit (in-person or virtual)

Implementation Evaluation

Evaluation of the implementation success of high-intensity rehabilitation using the RE-AIM framework

16-22 months

What Are the Treatments Tested in This Trial?

Interventions

• i-STRONGER
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: i-STRONGER Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aegis Therapies, Inc.

Collaborator

Trials

1

Recruited

2,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A pilot study showed that high-intensity resistance training (i-STRONGER) significantly improved physical function in older adults in skilled nursing facilities compared to standard low-intensity rehabilitation.

This upcoming cluster-randomized trial will evaluate the effectiveness of i-STRONGER across 32 skilled nursing facilities over 12 months, aiming to enhance patient outcomes and inform best practices for rehabilitation in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities: An Effectiveness-Implementation Hybrid Type 1 Clinical Trial Protocol. Beisheim-Ryan, EH., Butera, KA., Hinrichs, LA., et al.[2023]

In a retrospective study of 60 nursing home patients, primarily elderly individuals with a median age of 75.5 years, the Barthel index showed a significant improvement of 17.9 points from admission to discharge, indicating effective rehabilitation outcomes.

The study found that 47% of patients were discharged after a median rehabilitation time of 15 weeks, with those living alone showing better initial functional status compared to those living with a partner, suggesting that living arrangements may influence rehabilitation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Geriatric rehabilitation in a nursing home and the Barthel Index as a parameter]. Zijp, EM., van den Bosch, JS., van Hezik, S.[2019]

In a study of 23,824 stroke patients aged 65 and over in skilled nursing facilities, rehabilitation therapy (RT) significantly increased the likelihood of discharge to home, especially for those with uncertain discharge outcomes.

The strongest benefits of RT were observed in patients who were not expected to be discharged within 30 days, highlighting the importance of providing intensive rehabilitation for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skilled nursing facility rehabilitation and discharge to home after stroke. Wodchis, WP., Teare, GF., Naglie, G., et al.[2016]

In a study of 2085 stroke patients over 4 years, 78.2% were discharged home, while 21.8% went to skilled nursing facilities (SNF), highlighting the significant proportion of patients needing further care after rehabilitation.

Factors such as older age, being separated or divorced, having Medicare insurance, dysphagia, and cognitive deficits were associated with a lower likelihood of being discharged home, while higher motor function scores increased the chances of home discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with discharge to home versus discharge to institutional care after inpatient stroke rehabilitation. Nguyen, VQ., PrvuBettger, J., Guerrier, T., et al.[2022]

Higher intensity therapy in skilled nursing facilities (SNFs) is associated with better patient outcomes, including increased rates of community discharge and shorter lengths of stay, based on a systematic review of eight observational studies.

There is moderate evidence supporting the benefits of higher therapy intensity, while future research is needed to strengthen the understanding of its impact on functional improvement and hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Intensity and Patient Outcomes in Skilled Nursing Facilities in the United States: A Systematic Review. Prusynski, RA., Gustavson, AM., Shrivastav, SR., et al.[2021]

The i-STRONGER program, which focuses on high-intensity functional resistance training, was found to be safe and feasible for older adults in skilled nursing facilities, with no adverse events reported and high treatment fidelity over 99%.

Patients participating in the i-STRONGER program showed a greater improvement in gait speed (0.13 m/s) and a trend towards better performance on the Short Physical Performance Battery compared to those receiving usual care, along with higher patient satisfaction and a shorter average length of stay by 3.5 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of High-Intensity Functional Resistance Training in a Skilled Nursing Facility: An Implementation Study. Gustavson, AM., Malone, DJ., Boxer, RS., et al.[2023]

In a study of 245 older adults undergoing inpatient rehabilitation, it was found that sleep disturbances are common, with participants averaging only 52.2% nighttime sleep and 15.8% daytime sleep during their stay.

More daytime sleep was linked to poorer functional recovery both at discharge and three months later, suggesting that excessive daytime sleeping may hinder rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More daytime sleeping predicts less functional recovery among older people undergoing inpatient post-acute rehabilitation. Alessi, CA., Martin, JL., Webber, AP., et al.[2021]

In a study of 698 older adults in skilled nursing facilities, higher cognitive scores and greater independence in activities of daily living (ADL) at admission were associated with better recovery in physical function, as measured by the Short Physical Performance Battery (SPPB).

Interestingly, higher initial SPPB scores and faster gait speeds at admission predicted smaller improvements in these measures, indicating that those who are already more mobile may not see as much functional recovery, highlighting the complexity of rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Admission Cognition and Function Predict Change in Physical Function Following Skilled Nursing Rehabilitation. Butera, KA., Gustavson, AM., Forster, JE., et al.[2023]

In a study of 4,988 patients in skilled nursing facilities, higher intensity of physical therapy (PT) and occupational therapy (OT) was linked to shorter hospital stays and better functional independence outcomes, as measured by the FIM instrument.

Specifically, increased PT and OT intensity improved mobility and activities of daily living for patients with various conditions, while speech and language therapy (SLT) also enhanced motor and executive control for stroke patients, indicating that more intensive therapy leads to better recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Jette, DU., Warren, RL., Wirtalla, C.[2022]

Over 33% of older adults admitted to skilled nursing facilities (SNFs) experience adverse events, such as falls, within the first 35 days of their stay, highlighting a significant safety concern for this population.

Key factors contributing to these adverse events include intrinsic factors like frailty and reduced muscle strength, as well as extrinsic factors such as inappropriate medication use, environmental hazards, and poor communication among staff, indicating areas for potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events and Their Contributors Among Older Adults During Skilled Nursing Stays for Rehabilitation: A Scoping Review. Okpalauwaekwe, U., Tzeng, HM.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32750132/

Application of High-Intensity Functional Resistance Training in ... Patients in i-STRONGER exhibited a 0.13 m/s greater change in gait speed than in the usual care group. Although not significant, i-STRONGER ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7530575/

Application of High-Intensity Functional Resistance ... This study evaluated high-intensity resistance training in SNFs, finding it safe and feasible, with improved gait speed and shorter length of stay.

3. academic.oup.com academic.oup.com/ptj/article/103/9/pzad053/7187087

An Effectiveness-Implementation Hybrid Type 1 Clinical Trial ... IntenSive Therapeutic Rehabilitation for Older skilled NursinG homE Residents (i-STRONGER) is a progressive, high-intensity rehabilitation ...

4. providermagazine.com providermagazine.com/Articles/Pages/High-intensity-Resistance-Training-in-Post-Acute-Care-Produces-Better-Outcomes.aspx

High-intensity Resistance Training in Post-Acute Care ... However, research has shown the trajectory of functional recovery following hospitalization and skilled nursing stay care is generally poor, ...

5. withpower.com withpower.com/trial/phase-functional-recovery-6-2022-2b244

i-STRONGER for Functional Recovery in Aging A high-intensity resistance training approach like i-STRONGER has shown better physical function in older adults in skilled nursing facilities, according to a ...