i-STRONGER for Functional Recovery in Aging

Recruiting at1 trial location

Overseen by Jennifer E Stevens-Lapsley, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Neurological diagnosis, Weight-bearing precautions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the i-STRONGER treatment 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 single-site pilot study. This suggests that more intense rehabilitation can lead to improved outcomes compared to standard low-intensity care. ^{1 2 3 4 5}

Is the i-STRONGER rehabilitation program safe for older adults in skilled nursing facilities?

The i-STRONGER program, which involves high-intensity resistance training, has been studied for its safety and feasibility in skilled nursing facilities. While high-intensity training can improve physical function, it is important to monitor for potential adverse events, such as falls, which are common among older adults in these settings. ^{3 4 6 7 8}

How is the i-STRONGER treatment different from other treatments for functional recovery in aging?

The i-STRONGER treatment is unique because it uses high-intensity resistance training specifically designed to challenge skeletal muscles, which is different from the low-intensity interventions typically used in skilled nursing facilities. This approach has shown better physical function improvements in older adults compared to standard care. ^{3 4 6 9 10}

Research Team

Jennifer E Stevens-Lapsley, PT, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• i-STRONGER (Behavioural Intervention)
• Usual Care (Other)

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.

Participant Groups

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+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Aegis Therapies, Inc.

Collaborator

Trials

1

Recruited

2,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation Intensity and Patient Outcomes in Skilled Nursing Facilities in the United States: A Systematic Review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Skilled nursing facility rehabilitation and discharge to home after stroke. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities: An Effectiveness-Implementation Hybrid Type 1 Clinical Trial Protocol. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Geriatric rehabilitation in a nursing home and the Barthel Index as a parameter]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Application of High-Intensity Functional Resistance Training in a Skilled Nursing Facility: An Implementation Study. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Factors associated with discharge to home versus discharge to institutional care after inpatient stroke rehabilitation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Admission Cognition and Function Predict Change in Physical Function Following Skilled Nursing Rehabilitation. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

More daytime sleeping predicts less functional recovery among older people undergoing inpatient post-acute rehabilitation. [2021]