Endurance Training for Physical Activity Benefits in Children

(MoTrPAC Trial)

Overseen By Cindy Stowe

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Prescription medications

Disqualifiers: Asthma, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how children's bodies change at a molecular level during endurance exercises like running or swimming. Researchers aim to observe internal changes after an intense workout and over a 12-week training period. The trial includes two parts: a one-time exercise test and a longer training program for some participants. Children aged 10-17, whether they exercise infrequently or are regular athletes, may qualify if they have been healthy without major medical issues.

As an unphased trial, this study provides a unique opportunity for participants to contribute to the scientific understanding of exercise's impact on young bodies.

Do I have to stop taking my current medications for the trial?

Yes, if you have been using any prescription medication daily or weekly in the past 3 months, you cannot participate in the trial, except for birth control.

What prior data suggests that endurance training is safe for children?

Research shows that endurance training safely and effectively boosts fitness in children and teens. Studies indicate that exercise lowers the risk of heart disease and improves overall health in young people. In children who undergo proper screening before starting, exercise programs have not caused negative effects. This suggests that endurance training is generally well-tolerated, especially when participants receive careful evaluation beforehand. Therefore, for those considering joining a clinical trial for endurance training, evidence suggests it is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endurance training for children because it emphasizes physical activity as a method to enhance health without relying on medication. Unlike traditional treatments that might focus on dietary changes or medications, endurance training directly improves cardiovascular fitness, strength, and overall well-being through sustained exercise. This approach is particularly appealing because it can instill lifelong healthy habits and potentially prevent health issues before they arise. By focusing on exercise, researchers hope to find out how much physical activity can actively contribute to better health outcomes in children, making it a proactive and sustainable health intervention.

What evidence suggests that endurance training could be effective for improving physical activity in children?

This trial will evaluate the effects of endurance training on physical activity benefits in children. Studies have shown that endurance training can significantly boost physical activity in children, increasing their energy and reducing tiredness. Being active helps kids perform better in school, improves brain health, and strengthens muscles, heart, and lungs. Research also suggests that those who engage in endurance training may have healthier hearts as they age compared to those who do not. Additionally, being active supports strong bones and muscle growth in children, promoting healthy development. Overall, evidence indicates that endurance training offers many health benefits for children. ^{6 7 8 9 10}

Who Is on the Research Team?

Mike E Miller, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 10-17 who are in good health, weigh at least 30 kg, can speak English well enough to understand the study, and either engage in regular endurance sports or have limited intense exercise experience. They must not use tobacco or drugs, be pregnant, have donated blood recently, take chronic medication (except birth control), or have serious chronic diseases.

Inclusion Criteria

I weigh at least 30 Kg.

Determined to be in good health by pre-participation medical history review performed at PERC

I exercise intensely no more than 2 days a week for up to 120 minutes.

Exclusion Criteria

Blood donation in the past 3 months (self-report)

I have high cholesterol or triglycerides based on tests or family history.

A doctor has confirmed I can't do physical activities due to my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Phase

Molecular transducers are measured in response to an acute exercise challenge

1 week

1 visit (in-person)

Intervention Phase

Participants are randomized to endurance exercise training or no exercise control for approximately 12 weeks

12 weeks

Multiple visits (in-person) for assessments and biospecimen collection

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endurance Training

Trial Overview

The MoTrPAC Pediatric Protocol examines how physical activity affects kids' bodies on a molecular level. It includes an acute exercise challenge to see immediate changes and a randomized controlled trial where participants do endurance training for about 12 weeks compared to a no-exercise group.

How Is the Trial Designed?

Group I: Cross Sectional LA Active Control 1 Intervention

Do not participate in intervention after single acute exercise test of Endurance Exercise.

Group II: Cross Sectional HA Active Control 1 Intervention

Do not participate in intervention after single acute exercise test of Endurance Exercise.

Group III: Endurance Exercise Active Control 1 Intervention

Participants randomized to EE participate in the intervention and complete the acute test and biospecimen collection following the intervention period.

Group IV: No Intervention Control Active Control 1 Intervention

The control group is randomized but does not participate in the intervention but does complete the acute test and biospecimen collection following the intervention period.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Broad Institute of MIT and Harvard

Collaborator

Trials

21

Recruited

16,300+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Children and adolescents generally have higher maximum oxygen consumption (VO2max) levels compared to older individuals, but the effectiveness of endurance training in improving aerobic fitness in prepubescent children is still debated.

To enhance VO2max in children, exercise training programs should follow adult standards for intensity and duration, as those that do often show improvements similar to those seen in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic response to endurance training in prepubescent children: a critical analysis. Rowland, TW.[2004]

Exercise training is safe for children and adolescents with congenital heart disease, with no reported adverse events linked to the interventions across 6 trials involving 642 participants.

The training showed efficacy in improving physical fitness, with significant enhancements in exercise capacity and cardiorespiratory fitness in several studies, although the evidence quality is considered low to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. Anderson, CAJ., Suna, JM., Keating, SE., et al.[2023]

A 12-week endurance training program significantly improved the aerobic capacity (Vo2 max) of prepubertal children, with an average increase of 7% in the trained group of 26 children, compared to controls.

The training led to a decrease in heart rate during submaximal workloads, indicating improved cardiovascular efficiency, although maximum heart rate and other cardiac output measures did not change significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an endurance training regimen on assessment of work capacity in prepubertal children. Lussier, L., Buskirk, ER.[2019]

High-intensity interval training (HIIT) significantly improves cardiorespiratory fitness in children and adolescents, as evidenced by better VO2max and heart rate indicators, based on a meta-analysis of 47 studies involving 2995 participants.

However, HIIT does not show significant effects on body shape or certain cardiovascular disease biomarkers, indicating that while it enhances fitness, it may not lead to changes in physical appearance or all metabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on physical morphology, cardiorespiratory fitness and metabolic risk factors of cardiovascular disease in children and adolescents: A systematic review and meta-analysis. Men, J., Zou, S., Ma, J., et al.[2023]

In a study involving 80 obese children, a 40-minute treadmill training session at 100% of the first ventilatory threshold (VT1) significantly improved cardiovascular risk factors, including a notable drop in total cholesterol and low-density lipoprotein levels.

The same group also showed a significant increase in maximum oxygen uptake (VO2max) and a decrease in perceived exertion (RPE), highlighting that longer and higher intensity exercise is more effective for improving health outcomes in obese children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk profile, oxygen uptake, and perceived exertion rate in children with obesity: the interactive effect of exercise intensity and duration. Elnaggar, RK., Elshazly, FA., Abdelbasset, WK., et al.[2022]

Trained children have higher VO2max values compared to untrained children, with these differences becoming more pronounced as children get older.

While exercise programs of sufficient intensity, frequency, and duration improve cardiorespiratory capacity in children, the optimal levels for these factors have not yet been determined, and more research is needed to understand how children's responses to endurance training compare to adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory responses to endurance training in children. Vaccaro, P., Mahon, A.[2018]

An 8-week endurance training program significantly improved ventilatory threshold (VT) by 19.4% and VO2max by 7.5% in eight previously untrained male children aged 10 to 14 years.

The training involved running four times a week, with a mix of continuous and interval running, demonstrating that structured endurance training can effectively enhance aerobic capacity in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilatory threshold and VO2max changes in children following endurance training. Mahon, AD., Vaccaro, P.[2007]

High-Intensity Interval Training (HIIT) improved peak oxygen uptake (V̇O2) in boys compared to a control group, but it was not superior to Constant-Intensity Endurance Training (CIET) for enhancing aerobic or anaerobic performance after three months of training.

Both pre- and post-pubertal boys showed similar improvements in fitness levels, indicating that maturity does not significantly influence the effectiveness of these training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of constant-intensity endurance training and high-intensity interval training on aerobic and anaerobic parameters in youth. Runacres, A., Mackintosh, KA., McNarry, MA.[2019]

A 12-week home exercise program combining aerobic and strength training significantly improved exercise endurance and strength in 11 pediatric heart transplant recipients, indicating that regular exercise can enhance physical performance in this population.

The intervention was safe, cost-effective, and led to measurable improvements in endurance and strength without adverse effects on heart rate or blood pressure, suggesting it could be a beneficial routine for children post-heart transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved exercise performance in pediatric heart transplant recipients after home exercise training. Patel, JN., Kavey, RE., Pophal, SG., et al.[2008]

Resistance training is increasingly recognized as a vital component of physical education and fitness programs for youth, addressing health issues related to inactivity and obesity.

The updated policy statement from the American Academy of Pediatrics emphasizes the safety and benefits of resistance training for both athletes and nonathletes, highlighting the need for effective implementation in youth fitness regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Training for Children and Adolescents. Stricker, PR., Faigenbaum, AD., McCambridge, TM.[2020]

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