Hoosier Sport for Heart Health in Kids

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Medical conditions, Physical limitations

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Hoosier Sport is a sport-based youth development program that uses the power of sport to teach children and adolescents sport and leadership skills while promoting health education. Conducted in rural middle and high schools, the program aims to enhance health and wellness by incorporating unique sports such as volleyball and flag football, along with leadership activities like goal setting and health education on the importance of exercise and a healthy lifestyle. The program runs for eight weeks each semester (Fall and Spring), with sessions twice a week during PE class, where college service-learning students lead the curriculum. Data on physical activity and psychosocial factors are collected to assess changes in health, ensuring confidentiality through strict IRB protocols.

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 participation in sports and health education activities.

What data supports the effectiveness of the treatment Hoosier Sport for heart health in kids?

Research shows that regular physical activity in children can improve fitness and reduce risk factors for heart disease, similar to benefits seen in adults. Programs that promote physical activity in schools have been shown to improve children's fitness and health profiles, suggesting that treatments like Hoosier Sport could be effective in enhancing heart health in kids. ^{1 2 3 4 5}

Is Hoosier Sport safe for children with heart conditions?

Participating in sports can be beneficial for children with heart conditions, but there are risks like sudden death and rhythm disturbances. Safety depends on individual assessments, and it's important to have regular heart check-ups and screenings. ^{6 7 8 9 10}

How is the Hoosier Sport treatment different from other treatments for heart health in kids?

Hoosier Sport is unique because it focuses on organized sports and physical activities to improve heart health in children, rather than using medication or traditional medical treatments. This approach emphasizes the benefits of physical activity for both physical and psychological health, especially for children with heart conditions. ^{5 11 12 13 14}

Eligibility Criteria

This trial is for middle and high school students in rural Indiana. It's designed to promote health education through sport and leadership activities. Participants should be interested in learning about exercise, healthy living, and willing to engage in sports like volleyball and flag football.

Inclusion Criteria

Must provide parental consent and student assent

Enrollment in a physical education class

Exclusion Criteria

Presence of medical conditions or physical limitations that prevent safe participation in physical activity, as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or a medical professional.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Intervention

Participants engage in an 8-week curriculum that includes unique sports activities, leadership exercises, and health education sessions designed to promote physical activity and well-being.

8 weeks

16 sessions (in-person, twice a week)

Follow-up

Participants are monitored for changes in physical activity and psychosocial factors after the intervention.

1 week

Data collection via accelerometers and questionnaires

Treatment Details

Interventions

• Hoosier Sport

Trial Overview The Hoosier Sport program is being tested for its effectiveness in improving health and wellness among youth. The intervention includes sports training, leadership skills development, and health education over an eight-week period during PE classes led by college students.

Participant Groups

Group I: Test group - Hoosier Sport Participants Experimental Treatment 1 Intervention

The intervention group in the Hoosier Sport study consists of students enrolled in the PE class who actively participate in the Hoosier Sport program. These students engage in an 8-week curriculum that includes unique sports activities, leadership exercises, and health education sessions designed to promote physical activity and well-being.

Group II: Control group Active Control 1 Intervention

The control group in the Hoosier Sport study consists of students who are not enrolled in the PE class and therefore do not participate in the Hoosier Sport program. These students continue with their regular school activities without the added sport, leadership, and health education components provided in the intervention.

Hoosier Sport is already approved in United States for the following indications:

Approved in United States as Hoosier Sport for:

• Physical activity promotion
• Health education
• Leadership skills development

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

The ACTIV'HOP study is a randomized controlled trial assessing the impact of adapted physical activity on health-related quality of life (HRQoL) and satisfaction with care in hospitalized children aged 5 to 18 years, aiming to improve their overall hospital experience.

The study hypothesizes that engaging in adapted physical activity during hospitalization will lead to better HRQoL at discharge and increased satisfaction with hospital care, with outcomes measured using validated questionnaires sent to families after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of adapted physical activity on health-related quality of life among hospitalized children and adolescents (the ACTIV'HOP randomized controlled trial): design and methods. Speyer, E., Vuillemin, A., Herbinet, A., et al.[2015]

Participation in sports and physical activities is crucial for children as it helps build strong bones and reduces the risk of obesity and insulin resistance.

Regular physical activity not only lowers cardiovascular risks in adults but also plays a significant role in improving overall health and longevity, especially in patients with heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7. Sport for special groups. Broderick, CR., Winter, GJ., Allan, RM.[2020]

Participation in school sports among adolescents with juvenile idiopathic arthritis (JIA) significantly increased from 31% in 2000 to 64% in 2015, indicating improved engagement in physical activity over time.

The decrease in exemption rates from school sports, from 44% to 16%, suggests that advancements in treatment options have likely enhanced the functional abilities of these patients, allowing for greater participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in school sports among children and adolescents with juvenile idiopathic arthritis in the German National Paediatric Rheumatologic Database, 2000-2015: results from a prospective observational cohort study. Milatz, F., Klotsche, J., Niewerth, M., et al.[2020]

Regular exercise significantly reduces the risk of chronic diseases, especially cardiovascular disease, and current research indicates that children today are less fit and more sedentary than those 20 years ago.

Programs like the Heart Smart Superkids/Superfit exercise initiative demonstrate that school-based health promotion can effectively improve children's fitness and positively influence their cardiovascular risk factors, suggesting that early lifestyle changes are crucial for long-term health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of physical activity in childhood. Harsha, DW.[2019]

Children with congenital heart disease should engage in daily physical activity, as it is crucial for their development and can be beneficial for their health.

After a thorough cardiological assessment to identify any risks, a sports medical examination is recommended to tailor advice on appropriate activity levels, helping these children improve both physically and psychologically through participation in sports with peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Congenital Heart Diseases and Sports]. Wippermann, F., Oberhoffer, R., Hager, A.[2017]

A review of 15 studies on sport eligibility for children with congenital heart disease (CHD) revealed inconsistencies between US and European guidelines, particularly for borderline conditions and severe defects that were not thoroughly evaluated.

Current recommendations primarily focus on competitive sports, neglecting recreational activities and the psychosocial impacts of activity restrictions, highlighting the need for comprehensive guidelines that address all types of CHD and include both competitive and recreational considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengths, Limitations, and Geographical Discrepancies in the Eligibility Criteria for Sport Participation in Young Patients With Congenital Heart Disease. Cantinotti, M., Giordano, R., Assanta, N., et al.[2019]

Physical training can significantly lower the risk of death from all causes in the general population, highlighting its importance for overall health.

While the risk of sudden cardiac death in young athletes is low (0.5 to 2 per 100,000 athletes per year), certain heart conditions pose risks, and regular cardiovascular screenings, including ECGs, are recommended to ensure safety in competitive sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac disease at risk in the young athlete]. Massoure, PL., Camus, O., Chenilleau, MC., et al.[2016]

The BOOSTH exergame, which uses a wrist-worn activity tracker to encourage physical activity among primary school children, is being tested in a cluster randomized controlled trial across 16 schools in the Netherlands to see if it can effectively increase moderate-to-vigorous physical activity (MVPA).

The study will also assess the feasibility of BOOSTH and its impact on cardiovascular health and health-related quality of life (HRQOL), with results expected to inform future recommendations for implementing exergames in children's health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effect of the Exergame BOOSTH Introduced to Improve Physical Activity and Health in Children: Protocol for a Randomized Controlled Trial. Ten Velde, G., Plasqui, G., Willeboordse, M., et al.[2020]

Children with congenital heart defects (CHD) have a significantly higher prevalence of being non-swimmers (16%) compared to healthy peers (4.3%), indicating a need for targeted interventions.

The risk of being unable to swim is particularly high in children with complex CHD, where nearly one in five are non-swimmers, highlighting the importance of swim learning programs to support their development and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide Survey Reveals High Prevalence of Non-Swimmers among Children with Congenital Heart Defects. Apitz, C., Tobias, D., Helm, P., et al.[2023]

Children with congenital heart disease are generally advised to participate in dynamic sports rather than static ones, as the type of sport can influence their safety and health outcomes.

Recommendations for sports participation should be individualized based on specific medical assessments, including exercise electrocardiograms and echocardiograms, rather than relying on invasive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Points of departure in sports counseling of children with congenital heart defects]. Rohmer, J., de Knecht, S.[2008]

The study found that levels of cholesterol and body fat in children aged 8 to 10 vary significantly by gender, ethnicity, and geographic location, indicating that these factors should be considered in health interventions.

Black males had higher total and high-density lipoprotein (HDL) cholesterol levels compared to white and Hispanic males, while white and black males had higher HDL levels than their female counterparts, highlighting the need for targeted health strategies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid and lipoprotein distributions in children by ethnic group, gender, and geographic location--preliminary findings of the Child and Adolescent Trial for Cardiovascular Health (CATCH). Belcher, JD., Ellison, RC., Shepard, WE., et al.[2022]

A study of 100 homeschool children aged 10-17 found that participation in organized sports or physical activities did not lead to higher levels of upper body or abdominal fitness, as measured by push-up and curl-up tests.

Additionally, the amount of time spent in these organized activities did not correlate with improved cardiorespiratory fitness, suggesting that homeschool children may require more unstructured physical activity to meet fitness recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organized Sports and Physical Activities as Sole Influencers of Fitness: The Homeschool Population. Kabiri, LS., Rodriguez, AX., Perkins-Ball, AM., et al.[2021]

Declining physical activity levels in children and youth are linked to serious health issues like obesity, diabetes, and heart disease, highlighting the need for intervention.

Governmental and non-governmental programs promoting sports and physical activity have successfully increased participation and improved health outcomes, demonstrating their effectiveness in enhancing overall well-being beyond just physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitness and health of children through sport: the context for action. Micheli, L., Mountjoy, M., Engebretsen, L., et al.[2011]

A review of 26 school sports policies revealed that most lack robust, evidence-based strategies for preventing injuries, particularly beyond concussions, which were the primary focus of many guidelines.

Existing policies often apply adult injury management evidence to children without considering their unique developmental needs, indicating a gap in tailored safety measures for young athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of sports injuries in children at school: a systematic review of policies. Göpfert, A., Van Hove, M., Emond, A., et al.[2022]

References

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

Effect of adapted physical activity on health-related quality of life among hospitalized children and adolescents (the ACTIV'HOP randomized controlled trial): design and methods. [2015]

2. Australia pubmed.ncbi.nlm.nih.gov

7. Sport for special groups. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Participation in school sports among children and adolescents with juvenile idiopathic arthritis in the German National Paediatric Rheumatologic Database, 2000-2015: results from a prospective observational cohort study. [2020]

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

The benefits of physical activity in childhood. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Congenital Heart Diseases and Sports]. [2017]

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

Strengths, Limitations, and Geographical Discrepancies in the Eligibility Criteria for Sport Participation in Young Patients With Congenital Heart Disease. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Cardiac disease at risk in the young athlete]. [2016]

8. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Effect of the Exergame BOOSTH Introduced to Improve Physical Activity and Health in Children: Protocol for a Randomized Controlled Trial. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nationwide Survey Reveals High Prevalence of Non-Swimmers among Children with Congenital Heart Defects. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Points of departure in sports counseling of children with congenital heart defects]. [2008]

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

Lipid and lipoprotein distributions in children by ethnic group, gender, and geographic location--preliminary findings of the Child and Adolescent Trial for Cardiovascular Health (CATCH). [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Organized Sports and Physical Activities as Sole Influencers of Fitness: The Homeschool Population. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Fitness and health of children through sport: the context for action. [2011]

14. England pubmed.ncbi.nlm.nih.gov

Prevention of sports injuries in children at school: a systematic review of policies. [2022]