Education + Coaching for Stroke

(U4S Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas, El Paso

Disqualifiers: Unable to consent, No transportation, others

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

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors become more active and reduce sitting time through education, movement activities, and personalized coaching. Participants will attend group sessions on physical activity, balance, and daily living activities. Some will also receive one-on-one coaching to further encourage physical activity. Eligibility requires having had a stroke at least six months ago and the ability to travel to the UTEP Rehabilitation Sciences Complex. The ultimate goal is to support stroke survivors in living healthier, more independent lives. As an unphased trial, this study provides a unique opportunity for stroke survivors to actively participate in research that could enhance their quality of life.

Will I have to stop taking my current medications?

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 this program is safe for stroke survivors?

A previous study demonstrated that stroke rehabilitation programs like United4Stroke (U4S) improve patient outcomes. The U4S program encourages participants to be more physically active and spend less time sitting. These programs typically achieve high attendance and satisfaction rates, indicating that participants generally find them easy to follow.

Research on similar programs has shown that increased activity and reduced sitting time can be safe and beneficial for stroke survivors. These programs prioritize participants' safety, and serious issues are rare. The combination of learning and coaching in these programs often helps participants lead healthier, more active lives without significant risks.

This study includes group learning sessions and optional one-on-one coaching, both focusing on safe and supported physical activity. Given the program's design, it is expected to be very safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the United4Stroke (U4S) program because it takes a unique approach to stroke recovery by combining education with personalized coaching. Unlike standard treatments that may focus solely on medical management or physical therapy, the U4S program emphasizes group-based learning on important lifestyle changes, such as increasing physical activity and preventing falls, while also offering individualized coaching to boost daily activity levels. Participants are equipped with Fitbits to track their progress, allowing for a more interactive and engaging recovery process. This holistic and personalized method could lead to better long-term outcomes for stroke survivors by encouraging active participation in their own recovery journey.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

Research has shown that stroke survivors who join rehab programs with both learning and personal coaching make significant strides in becoming active and recovering. This trial will compare two approaches: one group will participate in the United4Stroke program, which includes both group-based education and individualized coaching, while the other group will receive group-based education only. A study found that patients who adhere to rehab therapy within six months after a stroke tend to live longer. Additionally, engaging in more physical therapy can greatly improve skills like moving and balancing. For those in the United4Stroke program, combining learning sessions with personal coaching, especially using tools like a Fitbit, is expected to increase daily activity and reduce sitting time. These methods help stroke survivors become more independent and improve their quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Camila Torriani-Pasin, PhD, PT

Principal Investigator

The University of Texas at El Paso

Are You a Good Fit for This Trial?

The United4Stroke program is for individuals aged 18 or older who have experienced a stroke at least six months ago. Family caregivers are also welcome to participate. The program takes place in El Paso, TX and includes group education on physical activity and individual coaching sessions.

Inclusion Criteria

I had a stroke more than 6 months ago.

I can travel to the UTEP physical therapy building for visits.

My health condition is stable and not worsening quickly.

Exclusion Criteria

Individuals who attend less than 60% of the group-based educational sessions

I don't have a way to get to the study visits.

I need a caregiver who cannot attend with me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Participants undergo initial assessments including cognitive and physical evaluations, and are fitted with movement sensors

1 week

1 visit (in-person)

Intervention

Participants attend group-based education sessions and receive individualized coaching to increase physical activity and reduce sedentary behavior

12 weeks

12 visits (in-person)

Post-Intervention Assessment

Participants undergo post-intervention assessments to evaluate progress and provide feedback

1 week

2 visits (in-person)

Follow-up

Participants are monitored for retention of physical activity improvements and quality of life one month after the program concludes

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• United4Stroke (U4S)

Trial Overview This study tests a combination of group-based education and personalized coaching aimed at increasing physical activity and reducing sedentary time among stroke survivors. Participants will attend sessions over several months, including evaluations before, during, and after the program.

How Is the Trial Designed?

Group I: Group-Based Education plus Individualized Coaching Experimental Treatment 2 Interventions

Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will receive individualized coaching aimed at increasing daily step count, reducing sedentary behavior, and engaging in physical activities. They will also receive a Fitbit to be worn during the program.

Group II: Group-Based Education Only Active Control 1 Intervention

Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will not receive individualized coaching aimed at increasing daily step count, but will receive a Fitbit to be worn during the program.

Who Is Running the Clinical Trial?

University of Texas, El Paso

Lead Sponsor

Trials

17

Recruited

3,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06970210

United4Stroke (U4S) - El Paso Network Stroke Community ... Expected Results: In the short term, the U4S project is expected to yield measurable improvements in the adherence, attendance, and satisfaction rates of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X24004775

Upper-extremity motor recovery after stroke: A systematic ... Improvements in movement time, smoothness, velocities and trunk and shoulder movements,were reported during the first 2–3 months post-stroke ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10608684/

Stroke Recovery Is a Journey: Prediction and Potentials of ... However, after successful treatments and health optimization, more than 40% recover to good outcomes within 1 year [51]. These factors could ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.046008

Association Between Frequency of Rehabilitation Therapy ... We found a positive association between rehabilitation therapy within 6 months after stroke onset and long-term mortality in patients with stroke.

5. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Patients receiving higher doses of rehabilitation—ranging from 20 to 300 hours—experience significant improvements in motor impairment and ...

6. reporter.nih.gov reporter.nih.gov/search/10EECF0E478CC1DE7598B8961CAA4A01A2FFCEB861BF/project-details/10977033

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000388

Clinical Performance Measures for Stroke Rehabilitation These 13 performance measures are reported here and contain inclusion and exclusion criteria to allow calculation of rates of compliance in a variety of ...

8. medrxiv.org medrxiv.org/content/10.1101/2023.12.05.23299564v1.full-text

Association between frequency of rehabilitation therapy ... The results showed that the mortality rate was lower in non-disabled patients who received <40 rehabilitation therapy sessions after stroke (HR ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1423517/full

Efficacy and safety of very early rehabilitation for acute ... This meta-analysis proved that VER could elevate the risk of death after stroke and stroke severity during hospitalization. However, it significantly lowered ...