Physical Activity Program for Cardiovascular Risk

Overseen By Janette Watkins M Dr, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Uncontrolled hypertension, cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 28

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Lion Hearts to determine if it can boost heart health by encouraging mothers and their children to exercise together. The 12-week program takes place at local CrossFit gyms and focuses on exercises, teamwork, and health education. The study will assess whether participants become more active and healthier, and how the program influences family motivation and dynamics. Ideal participants are mothers with children aged 10-17 who can exercise safely and have transportation to the gym. The results will help refine the program for future studies. As an unphased trial, this study offers a unique opportunity to contribute to innovative health solutions for families.

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 focuses on physical activity and does not mention medication changes.

What prior data suggests that this physical activity program is safe for improving cardiovascular health?

A previous study found that the Lion Hearts Family-Based Physical Activity Program had manageable side effects for individuals at risk of heart problems. Participants generally experienced the program without serious issues. The program encourages families, especially mothers and children, to become more active to enhance heart health. It offers fun exercises and health education in a community setting. To date, no major negative effects have been reported, suggesting the program is safe for most people seeking to improve heart health through increased physical activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lion Hearts Physical Activity Program because it offers a fresh approach to improving cardiovascular health through family-based, high-intensity functional training (HIFT) in partnership with local CrossFit affiliates. Unlike standard treatments for cardiovascular risk, which often focus on medication and diet changes, this program emphasizes community support and physical activity to engage both mothers and their children. By integrating exercise into family routines, the program aims to make sustainable lifestyle changes that could lead to improved heart health.

What evidence suggests that the Lion Hearts Physical Activity Program is effective for improving cardiovascular health?

Research shows that being active can greatly improve heart health. Studies have found that more physical activity lowers the risk of heart disease and related deaths. One community program improved heart health in both the short and medium term by encouraging regular exercise. Following recommended exercise guidelines can also cut the risk of dying from heart disease by nearly half. This trial will evaluate the Lion Hearts Family-Based Physical Activity Program, which focuses on family-centered physical activity, to determine its effectiveness in enhancing heart health. Participants may either join the Lion Hearts program or be placed in a waitlist control group, continuing their usual activities before being offered the program after the trial's completion. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The Lion Hearts trial is for mother-child pairs interested in improving their heart health. Participants should be willing to engage in a physical activity program at local CrossFit gyms, attend twice-weekly fitness sessions, and complete various health assessments. Specific eligibility details are not provided.

Inclusion Criteria

I can get to the gym twice a week for CrossFit.

Both mother and child must be able to safely engage in moderate-to-vigorous physical activity, as determined by pre-participation health screening (e.g., PAR-Q+)

I am between 10 and 17 years old.

Exclusion Criteria

I don't have any health issues that make exercise unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants engage in a 12-week community-based physical activity intervention with twice-weekly fitness sessions

12 weeks

24 visits (in-person)

Mid-intervention Assessment

Participants undergo mid-intervention assessments including surveys, fitness testing, and accelerometry

1 week

1 visit (in-person)

Post-intervention Assessment

Participants complete post-intervention assessments including surveys, fitness testing, and optional lab work

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in physical activity, fitness, and cardiovascular health markers

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lion Hearts Family-Based Physical Activity Program

Trial Overview

This study tests the 'Lion Hearts' program, which involves family-based workouts and education on cardiovascular health over 12 weeks. The goal is to see if this community-driven approach can boost physical activity levels, improve fitness, enhance heart health markers, and positively affect family dynamics.

How Is the Trial Designed?

Group I: Lion Hearts Physical Activity Program Experimental Treatment 1 Intervention

Participants in this group will take part in Lion Hearts, a community-based physical activity program delivered in partnership with local CrossFit affiliates. The program uses high-intensity functional training (HIFT) and family-based co-design strategies to promote cardiovascular health and increase moderate-to-vigorous physical activity among mothers and their children.

Group II: (Control): Waitlist (Delayed Lion Hearts Program) Active Control 1 Intervention

Participants in this group will serve as a waitlist control and will not receive the intervention during the initial study period. They will continue with their usual activities and will be offered the Lion Hearts program after the completion of the trial.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07147387

Study Details | NCT07147387 | Lions Hearts: A Community ...

The Lion Hearts study is a three-phase, community-based research project designed to reduce multigenerational cardiovascular disease (CVD) risk through a family ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12316667/

Physical Activity for Cardiovascular Risk Factor Reduction

Strong evidence demonstrates a significant relationship between greater amounts of physical activity and decreased incidence of cardiovascular ...

3.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-017-4485-3

Effectiveness of a physical activity program on cardiovascular ...

This community-based physical activity program improved cardiovascular health in the short- as well as medium-term, and promoted regular physical activity in ...

4.

ehnheart.org

ehnheart.org/wp-content/uploads/2023/05/05737-Physical-activity-report-final-2.pdf

Physical activity policies for cardiovascular health

y CVD accounts for 45% of all deaths in Europe and 37% of all deaths in the EU. y The main forms of CVD are ischaemic heart disease (IHD) and stroke. IHD is the ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11057847/

Physical activity, exercise and adverse cardiovascular ...

Individuals meeting recommended physical activity guidelines had 45% lower risk of all-cause and 46% lower risk of CVD mortality compared with inactive ...

6.

withpower.com

withpower.com/trial/phase-cardiovascular-risk-8-2025-0e987

Physical Activity Program for Cardiovascular Risk

... Lion Hearts Family-Based Physical Activity Program will have tolerable side effects & efficacy for patients with Cardiovascular Risk. Learn more about the

7.

azed.gov

azed.gov/wellness/school-health-office-resources

SCHOOL HEALTH OFFICE RESOURCES

A Cardiac Emergency Action Plan is a written plan that explains the exact actions that will take place in an emergency. These actions should be very clear and ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2801902/

A Novel Family-Based Intervention Trial to Improve Heart Health

Family members of patients with cardiovascular disease (CVD) may be at increased risk due to shared genes and lifestyle. Hospitalization of a family member ...

9.

crob.ca.gov

crob.ca.gov/wp-content/uploads/2019/08/C-ROB_Annual_Report_September_14_2018.pdf

SEPTEMBER 14, 2018 C-ROB REPORT

referred to a program. The data collected should include: ▫ Pre- and post-program risk assessment scores that include dynamic risk;.