Physical Activity Program for Sedentary Lifestyle

(SPLASH Trial)

Overseen By Breanne Wilhite, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Not in 3rd-5th grade, others

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

Compensation: Varies

Number of Visits: 3

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test if a multilevel (school, home) physical activity intervention for school-aged (3rd-5th grade) children can increase physical activity levels. The main question\[s\] it aims to answer are: * The impact of the multilevel program on children's physical literacy and physical activity over one school year. Hypothesis: * Whether the program effects are different by children's gender or weight status * Whether changes in children's ability, confidence and motivation for physical activity are related to changes in physical activity levels. Schools will be randomly assigned to receive the multilevel intervention or a control group. Participants in the intervention group will receive a new school curriculum during regular physical education classes and information for families on what school activities can be done at home. Researchers will compare outcomes according to intervention and control group assignments.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment The Rising New York Road Runners program for a sedentary lifestyle?

Research shows that physical activity is linked to lower death rates from heart disease and other causes, and even moderate activity can significantly improve health. Exercise programs have been shown to improve fitness and quality of life, suggesting that similar programs like The Rising New York Road Runners could help reduce sedentary lifestyles. ^{1 2 3 4 5}

Is the Physical Activity Program for Sedentary Lifestyle generally safe for humans?

Research on physical activity programs, including those for sedentary individuals, shows that while minor injuries like muscle strains can occur, serious adverse events are rare. Programs often recommend starting slowly and gradually increasing intensity to ensure safety. ^{6 7 8 9 10}

How does the Rising New York Road Runners program differ from other treatments for a sedentary lifestyle?

The Rising New York Road Runners program is unique because it focuses on promoting a generally active lifestyle rather than just structured exercise, which aligns with the new paradigm of physical activity for health improvement. This approach is different from traditional exercise programs that emphasize specific regimens for fitness, as it encourages simple, everyday activities to enhance overall health and longevity. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for children in the 3rd to 5th grade who attend a school participating in the intervention and take part in physical education classes. There are no specific exclusion criteria provided.

Inclusion Criteria

Child attends school participating in the intervention

In the 3rd, 4th or 5th grade

Participates in the school's physical education class

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline Assessment

Children will wear an Actigraph accelerometer for 7 days to measure baseline physical activity levels and fundamental movement skills will be assessed

1 week

1 visit (in-person)

Intervention

Participants receive the Rising New York Road Runners program, a school-based physical education curriculum with a family engagement component

One school year

Follow-up

Participants are monitored for changes in physical literacy and physical activity levels

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• The Rising New York Road Runners program

Trial Overview The trial tests a multilevel physical activity program called Rising New York Road Runners, comparing its impact on kids' physical literacy and activity levels over one year against schools not receiving it.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component.

Group II: Control Active Control 1 Intervention

Standard school operating procedures

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Findings from Research

Cardiac rehabilitation, which includes exercise training and potentially other interventions, is effective for patients with coronary heart disease, leading to significant reductions in all-cause and cardiac mortality, nonfatal reinfarction, and hospitalization rates, based on a review of 71 trials involving 13,824 patients.

Despite its effectiveness, certain groups such as the elderly, women, and those with comorbidities are underrepresented in clinical trials, highlighting the need for broader inclusion in future research and the promotion of cardiac rehabilitation by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Oldridge, N.[2022]

Regular exercise significantly increases markers of exercise capacity, such as VO2max and ventilatory threshold (VT), which can enhance overall quality of life, especially for patients with health limitations.

Exercise serves as a positive health recommendation that not only improves physical fitness but may also indirectly encourage patients to adopt healthier behaviors, contrasting with traditional negative health advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. Foster, C., Cadwell, K., Crenshaw, B., et al.[2019]

A 24-week behavioral modification program using pedometers and telephone support significantly increased physical activity by an average of 2744 steps per day and reduced sedentary behavior by 23 minutes per day in type 2 diabetes patients.

These positive changes in physical activity and reduced sedentary time were still evident one year later, with an increase of 1872 steps per day and a decrease of 12 minutes in sedentary behavior, demonstrating the program's lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. De Greef, KP., Deforche, BI., Ruige, JB., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A study analyzing data from the 1996 Behavioral Risk Factor Surveillance System found that individuals who perceive their neighborhoods as unsafe are more likely to be physically inactive.

Addressing concerns about neighborhood safety could be crucial in promoting physical activity, especially among high-risk populations such as older adults and racial/ethnic minorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neighborhood safety and the prevalence of physical inactivity--selected states, 1996. [2022]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

The American College of Sports Medicine's guidelines for exercise training have historically focused on enhancing aerobic capacity and body composition, but recent research suggests they may not fully address the health needs of sedentary adults.

A new approach emphasizes promoting general physical activity over strict exercise training, as studies show that a more active lifestyle is linked to better health outcomes, longevity, and performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

J.B. Wolffe Memorial Lecture. Health consequences of physical activity: understanding and challenges regarding dose-response. Haskell, WL.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. [2022]

2. Austria pubmed.ncbi.nlm.nih.gov

[Physical activity for decreasing cardiovascular mortality and total mortality. A public health perspective]. [2006]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. [2019]

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

Children with cancer and their cardiorespiratory fitness and physical function-the long-term effects of a physical activity program during treatment: a multicenter non-randomized controlled trial. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

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

Neighborhood safety and the prevalence of physical inactivity--selected states, 1996. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

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

Perceptions of neighborhood characteristics and leisure-time physical inactivity--Austin/Travis County, Texas, 2004. [2008]

10. Brazil pubmed.ncbi.nlm.nih.gov

[Behavioral risk factors and readiness in amateur marathon runners 18-64 years of age in Bogotá, Colombia, 2014]. [2017]

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

J.B. Wolffe Memorial Lecture. Health consequences of physical activity: understanding and challenges regarding dose-response. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Physical fitness gains following simple environmental change. [2015]

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

Aging and Physiological Lessons from Master Athletes. [2020]

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

Modifications to the Active Living Every Day (ALED) course for adults with arthritis. [2023]

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

The relationship between expectations for aging and physical activity among older adults. [2022]