Hospital-Based Walking Program for Early Mobilization

(STRIDE Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Previous STRIDE participation

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the implementation and operation of a supervised walking program, called STRIDE, in 32 additional VA hospitals. The goal is to help hospitalized older Veterans remain active and improve their overall health through walking. The trial will compare two support methods for these hospitals: one providing basic tools and resources, and another offering more hands-on assistance if needed. Veterans aged 60 and older, staying in general medicine wards where the STRIDE program is available, are eligible to participate. As an unphased trial, it offers Veterans the chance to contribute to research that could enhance hospital care and improve health outcomes for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Hospital-Based Walking Program (STRIDE) is safe for hospitalized older Veterans?

Research has shown that hospital walking programs, such as STRIDE, are generally safe for patients. Studies have found that walking during a hospital stay can prevent loss of mobility and reduce muscle weakness. These programs are usually well-received, with few reports of serious side effects.

A thorough review found that early mobilization after illness or surgery can reduce muscle weakness and shorten hospital stays. This indicates that programs like STRIDE are not only safe but also beneficial for older patients.

Although direct data on negative effects from these programs is limited, their proven benefits and regular use in hospitals suggest they are a safe way to improve patient health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hospital-Based Walking Program, known as STRIDE, because it aims to enhance patient mobility in a hospital setting, which is a crucial factor for recovery. Unlike typical mobility treatments that might rely on physical therapy sessions alone, STRIDE incorporates a structured walking program that is integrated into daily hospital routines. The program is distinctive because it offers two levels of support: Foundational Support, which provides resources and tools to implement the program, and Enhanced Support, which intensifies assistance through personalized facilitation and problem-solving. This approach not only supports hospitals in establishing the program but also in maintaining it, potentially leading to better patient outcomes and faster recovery times.

What evidence suggests that this walking program is effective for hospitalized older Veterans?

Research has shown that early movement, such as with the Hospital-Based Walking Program (STRIDE), greatly benefits older adults in the hospital. Studies have found that walking programs reduce muscle weakness and shorten hospital stays. This leads to better recovery and lowers the risk of complications from inactivity. In this trial, participants will join either the Enhanced Support arm or the Foundational Support arm, both implementing the STRIDE program for older Veterans to keep them active during their hospital stay. This approach is linked to better health and a quicker return to daily life. Overall, STRIDE is designed to boost health by encouraging movement, which is key for maintaining strength and independence. ^{3 6 7 8 9}

Who Is on the Research Team?

Courtney H Van Houtven, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Kelli Dominick Allen, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Susan N. Hastings, MD MHSc

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for hospitals that want to implement a walking program called STRIDE for older Veterans. Hospitals must sign an agreement to participate and have not been part of the previous Function QUERI study. The clinical outcomes will focus on patients aged 60 or above admitted to medicine wards offering the STRIDE program.

Inclusion Criteria

I am 60 or older and admitted to a ward that offers the STRIDE program.

Sites not meeting benchmarks for adoption of STRIDE will receive higher-intensity implementation support (Enhanced REP).

Site inclusion criteria includes submission of a signed participation agreement.

Exclusion Criteria

The eight STRIDE sites that have previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03300336) will be excluded from enrollment in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the STRIDE program at 32 VA hospitals with either foundational or enhanced support

10 months

Ongoing hospital visits for program implementation

Evaluation

Evaluation of implementation outcomes such as penetration, adoption, and fidelity at 10 months

3 months

Follow-up

Participants are monitored for sustainability and effectiveness of the STRIDE program

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Hospital-Based Walking Program (STRIDE)
• Implementation Strategy: Enhanced REP
• Implementation Strategy: Foundational REP

Trial Overview The study aims to compare different strategies for implementing the STRIDE walking program in VA hospitals. It uses a type III hybrid design framework, assessing how well each strategy works in getting hospitals to adopt and sustain the walking program.

How Is the Trial Designed?

Group I: Enhanced Support Experimental Treatment 1 Intervention

Enhanced Support begins with the same activities as Foundational Support. Hospitals that are randomized to Enhanced Support and do not meet STRIDE initial program benchmarks within 6 months will continue with Foundational support and also receive higher intensity support for a period of 4-6 months. Hospitals that have sustained their implementation will continue low-touch activities while those that have been randomized to the enhanced support arm and met the initial program benchmark at 6-months but have not sustained (did not meet the sustainment benchmark), will begin engaging in high-touch activities. The higher intensity support will consist of facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship. Facilitation will be provided by Function QUERI team members.

Group II: Foundational Support Active Control 1 Intervention

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: STRIDE Toolkit; Online shared resources (SharePoint) access for clinical program training materials; Data dashboard to assist hospitals with tracking their own data; Diffusion Networks to promote peer-to-peer sharing and implementation support; and Microsoft TEAMS Channels.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790254/

protocol for a type III effectiveness-implementation hybrid trial Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11069628/

Mobilizing Progress: A Comprehensive Review of the ... Key findings indicate that early mobilization is associated with numerous benefits, including reduced muscle weakness, a shorter duration of ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1475-6773.14307

The business case for hospital mobility programs in ... To conduct a business case analysis for Department of Veterans Affairs (VA) program STRIDE (ASsisTed EaRly MobIlization for hospitalizeD older VEterans)

4. withpower.com withpower.com/trial/phase-5-2021-7927f

Hospital-Based Walking Program for Early Mobilization ... Trial Overview The study aims to compare different strategies for implementing the STRIDE walking program in VA hospitals. It uses a type III hybrid design ...

5. ctv.veeva.com ctv.veeva.com/study/implementing-a-hospital-based-walking-program-stride-function-queri20

Implementing a Hospital-Based Walking Program (STRIDE) Function QUERI 2.0 aims to compare implementation strategies for large-scale spread of STRIDE, a supervised walking program for hospitalized older Veterans.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6371091/

Early Mobility in the Hospital: Lessons Learned from ... Previous studies have demonstrated the potential of inpatient walking to prevent declines in mobility during hospital stays and to reduce ...

7. implementationsciencecomms.biomedcentral.com implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-024-00544-5

protocol for a type III effectiveness-implementation hybrid trial Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/nop2.1496

A systematic review and meta‐analysis: Assessment of ... The aim of this study is to assess effect of hospital walking programs on outcomes for older inpatients and to characterize hospital walking dose reported ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209083

Early Active Mobilization during Mechanical Ventilation in ... Early active mobilization may mitigate ICU-acquired weakness, increase survival, and reduce disability.