StrongPeople StrongHearts for Stroke

Overseen By Hannah Wilson, PhD, RDN, LD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clemson University

Must not be taking: Anti-seizure medications

Disqualifiers: Unstable arrhythmias, Dementia, Severe hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors in South Carolina improve their health and quality of life by testing a program called StrongPeople StrongHearts. The program encourages healthy habits, such as increased exercise and better nutrition, and is delivered online to reach rural participants. One group will also receive a weekly grocery box with healthy food to support these changes. The program supports stroke survivors who struggle with activities like walking or daily tasks. Those who had a stroke over six months ago, have a higher body weight, and can use a computer or smartphone to participate online might be a good fit for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to research that could significantly enhance the quality of life for stroke survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-seizure medications, you cannot participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the StrongPeople StrongHearts and Strong SC programs are generally easy for participants to handle. These programs aim to improve health habits like exercise and healthy eating, which are known to be safe and beneficial. Previous studies on similar community programs have not found any major negative effects, indicating safety. However, as with any new program, participants might feel some discomfort while adjusting to new routines. Overall, these programs are designed to promote healthy living and are expected to be safe for stroke survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StrongPeople StrongHearts and Strong SC programs because they take a unique approach to supporting stroke survivors. Unlike traditional treatments that might focus on medication or physical therapy alone, the StrongPeople StrongHearts program is a 12-week group initiative tailored specifically to the needs and abilities of community-dwelling, chronic stroke survivors. The Strong SC variant adds an innovative twist by including a medically tailored grocery program, potentially addressing nutritional needs alongside physical rehabilitation. This holistic approach might offer a new way to enhance recovery and improve quality of life for stroke survivors, making it a promising area of study.

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

Research shows that the StrongPeople StrongHearts program can improve health in people who have had a stroke. Studies have found that similar programs enhance heart health and overall well-being, particularly for those in rural areas. Participants in these studies became more physically active and showed better heart health indicators. The program also increased their self-confidence and social support, crucial for making lasting healthy changes. In this trial, participants in the Strong SC arm will receive the StrongPeople StrongHearts program combined with a supplemental medically tailored grocery (MTG) program, which could simplify healthy eating. Overall, these strategies have shown promise in helping people adopt healthier habits and improve their quality of life. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for stroke survivors in South Carolina, particularly those who have completed hospital treatment and therapies but still struggle with daily tasks. It aims to help them form healthy habits like exercising and eating well, even if they live in rural areas with limited access to resources.

Inclusion Criteria

BMI > 25 kg/m2

Access to computer or smart phone with internet to participate in a virtual intervention

I was diagnosed with a stroke over 6 months ago.

Exclusion Criteria

My blood pressure is not higher than 200/110 mmHg at rest.

I am currently participating in a trial focused on improving my physical or mental recovery.

I have had a blood clot in my leg or lung in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the StrongPeople StrongHearts program, with some receiving a supplemental medically tailored grocery program

12 weeks

Virtual sessions

Follow-up

Participants are monitored for lifestyle behaviors and health outcomes after the intervention

12 weeks

Open-label extension (optional)

Control group participants receive the Strong SC intervention after the follow-up period

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StrongPeople StrongHearts
• Strong SC

Trial Overview The 'StrongPeople StrongHearts' program is being tested to see if it can improve the health choices and quality of life for stroke survivors. The program will be delivered online, making it accessible for participants in remote locations. Additionally, one group will receive a weekly grocery box to enhance their diet.

How Is the Trial Designed?

Group I: StrongSC Experimental Treatment 1 Intervention

The Strong SC arm combines the StrongPeople StrongHearts program with a supplemental medically tailored grocery (MTG) program.

Group II: StrongPeople StrongHearts Experimental Treatment 1 Intervention

The StrongPeople StrongHearts arm follows the standard 12-week StrongPeople StrongHearts group program, systematically adapted to the needs and abilities of community-dwelling, chronic stroke survivors.

Group III: Control Active Control 1 Intervention

No intervention will be administered during the wait-list control period.

Who Is Running the Clinical Trial?

Clemson University

Lead Sponsor

Trials

38

Recruited

8,200+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. withpower.com withpower.com/trial/phase-stroke-5-2025-d0c7d

StrongPeople StrongHearts for Stroke The goal of this research project is to test StrongPeople StrongHearts, a health program, to see if it helps stroke survivors in South Carolina make better ...

2. scresearch.org scresearch.org/studies/browse/by_keyword/exercise

Browsing 13 studies for Exercise The goal of this research project is to test StrongPeople StrongHearts, a health program, to see if it helps stroke survivors in South Carolina make better ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009333

Strong Hearts, Healthy Communities-2.0 Cluster ... The SHHC-2.0 intervention demonstrated significant, clinically meaningful improvements in multiple CVD risk factors among at-risk rural midlife ...

4. researchgate.net researchgate.net/publication/365423802_Improvements_and_Maintenance_of_Clinical_and_Functional_Measures_Among_Rural_Women_Strong_Hearts_Healthy_Communities-2_0_Cluster_Randomized_Trial

Improvements and Maintenance of Clinical and Functional ... The within-group analysis strongly suggests maintenance or further improvement in outcomes at 48 weeks. Conclusions This cardiovascular disease ...

5. strongpeopleprogram.org strongpeopleprogram.org/wp-content/uploads/2021/04/strong-people-publications_4.12.2021.pdf

TBM - StrongPeople We investigated the direct and indirect effects of the SHHC intervention through changes to self-efficacy, social support, and built environment perception, on ...

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. sc.edu sc.edu/about/signature_events/discover_uofsc/find_presenter/

Find a Presenter - Discover USC Use the Find a Presenter form to search for Presentations, Presenters or Mentors, with a variety of search criteria for each.