Moderate-Intensity Exercise for Biomarkers

Overseen By Jamie Cooper, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Georgia

Disqualifiers: Nut allergy, No transportation, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how short sessions of moderate-intensity exercise, such as using an elliptical machine, affect certain health markers and mental well-being in college students. Researchers compare students who are usually active with those who are more sedentary. The trial includes a brief exercise session and blood tests to measure changes. College students who consider themselves active (exercising 150 minutes a week or more) or sedentary (less than 30 minutes a week) and are willing to try moderate exercise could be a good fit. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to foundational knowledge.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on exercise and biomarkers, so it's likely you won't need to stop, but you should confirm with the study team.

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

Research shows that using an elliptical machine is generally safe and easy to handle. Studies have found that elliptical workouts are low-impact, meaning they are gentle on the joints. This makes them suitable for people of all fitness levels, including those with joint issues.

Benefits of using an elliptical include burning calories and improving heart health. These machines also help boost stamina and strengthen muscles. No major reports of negative effects from moderate-intensity elliptical workouts suggest they are safe for most people.

Since this study involves moderate-intensity exercise on an elliptical machine, it is likely a safe option for participants. Always consult a healthcare provider before starting any new exercise program to ensure it suits individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of moderate-intensity exercise, specifically using an elliptical, to influence biomarkers in both sedentary and active individuals. Unlike traditional treatments that might rely on medication or more invasive methods to affect biomarker levels, this exercise protocol is non-invasive and can be easily integrated into daily life. The trial hopes to uncover how just a brief session of elliptical exercise, with a total of 8 minutes at a targeted heart rate, could offer health benefits, potentially providing a simple and accessible way to improve health markers for various populations.

What evidence suggests that elliptical activity might be an effective treatment for changing biomarkers in college students?

Research has shown that using an elliptical machine can increase energy use and improve fitness. One study found that small elliptical devices burned an additional 87.9 calories while sitting. Another study demonstrated that elliptical workouts strengthened leg muscles, particularly the quadriceps. Although these studies primarily emphasize physical benefits, moderate exercise like this often links to better mental health. In this trial, both sedentary and active individuals will engage in moderate-intensity elliptical workouts, potentially enhancing both physical and mental well-being for college students. ^{4 5 6 7 8}

Who Is on the Research Team?

Jennifer L Gay, PhD

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

This trial is for healthy college students aged 18-34 who can pass a basic physical activity readiness questionnaire. Participants should either be sedentary or active, meeting exercise guidelines. They must be willing to do blood tests and a 12-minute elliptical workout, and they need to speak English.

Inclusion Criteria

Generally healthy participants answering 'no' to all 7 questions on the 2020 Physical Activity Readiness Questionnaire

Ability to speak and read English to understand study protocols

Participants in sedentary group (<30min/week of exercise) or meeting exercise guidelines group (>=150min/week of exercise)

Exclusion Criteria

Allergy to nuts

I don't have a way to get to the lab or park there if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Pre-test Data Collection

Participants complete pre-test data collection including blood draws and reporting of food and transportation methods

1 day

1 visit (in-person)

Exercise Intervention

Participants perform 12 minutes of moderate-intensity exercise on an elliptical machine, including warm-up and cool-down

1 day

1 visit (in-person)

Post-test Data Collection

Participants complete post-test data collection including blood draws and a mental health questionnaire

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate changes in biomarkers and mental health post-exercise

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Elliptical Activity

Trial Overview The study aims to compare how moderate-intensity exercise on an elliptical machine affects biomarkers in physically active versus sedentary college students. It also looks at the impact of such activity on their mental health.

How Is the Trial Designed?

Group I: Sedentary Individuals - Acute Moderate-Intensity Exercise Experimental Treatment 1 Intervention

8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.

Group II: Active Individuals - Acute Moderate-Intensity Exercise Experimental Treatment 1 Intervention

8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Published Research Related to This Trial

Regular physical activity significantly improves cardiovascular health, with effects comparable to traditional risk factors like smoking and high cholesterol, especially when engaging in intensive activities that exceed 6 METs.

Increasing cardiorespiratory fitness by just 1 MET can reduce cardiovascular risk by about 20%, and while exercise can pose a risk of sudden cardiac death, this risk is greatly mitigated by consistent training, making the overall benefits of exercise very favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiorespiratory fitness. Importance of sports for health]. Schmermund, A.[2006]

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

Indoor cycling classes can reach high exercise intensities, with participants spending significant time (52% and 35% of class duration) above the ventilatory threshold, indicating a high level of exertion.

Despite a moderate average intensity (74% and 66% of Vo2max), there were instances where the exercise intensity exceeded Vo2max, suggesting that indoor cycling can be classified as a high-intensity workout, which may enhance its effectiveness but also increase the risk of overexertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic responses during indoor cycling. Battista, RA., Foster, C., Andrew, J., et al.[2022]

Regular physical activity is a crucial intervention for preventing coronary artery disease, significantly reducing cardiovascular morbidity and mortality through various biochemical pathways, unlike conventional drug therapies.

While moderate exercise is beneficial, higher intensity workouts may offer superior effects; however, excessive training can lead to negative outcomes like atrial fibrillation, indicating a threshold for optimal exercise benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of cardiovascular diseases through sport and physical activity: A question of intensity?]. Wernhart, S., Dinic, M., Pressler, A., et al.[2018]

Engaging in both moderate endurance exercise and specific strength training programs significantly enhances physical performance and improves cardiovascular health, making them essential for managing cardiovascular risk factors and diseases.

Higher-intensity interval training is now recommended alongside traditional exercise methods, with a focus on personalized load control to optimize recovery and performance, emphasizing that increasing daily activity, such as achieving over 7500 to 10,000 steps, also contributes positively to cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sport and exercise in prevention and therapy of cardiovascular diseases]. Hacke, C., Weisser, B.[2021]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

Incorporating lifestyle interventions, particularly moderate-intensity exercise, alongside pharmacological therapy is crucial for preventing further cardiovascular diseases, as recommended by the American Heart Association and American College of Sports Medicine.

Regular exercise (30-40 minutes, four to five times a week) can significantly improve cardiovascular health by enhancing risk factors like dyslipoproteinemia and insulin resistance, normalizing endothelial function, and slowing down atherosclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical exercise in secondary prevention of coronary heart disease]. Shutt, A., Bolotova, EV., Khalle, M.[2017]

Exercising in reverse on a modified elliptical trainer at lower inclines (6° and 12°) resulted in greater peak knee valgus and hip abduction, which may be important for individuals with knee issues, but also led to decreased peak knee flexion angles.

For individuals looking to strengthen their quadriceps safely, exercising in the forward direction or increasing the incline on the elliptical trainer may be more beneficial, despite the potential risks associated with knee joint kinematics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement direction impacts knee joint kinematics during elliptical exercise at varying incline angles. Hummer, ET., Murphy, EN., Suprak, DN., et al.[2021]

Eccentrically-focused resistance exercise (ECC RX) resulted in significantly higher heart rates and oxygen consumption compared to concentrically-focused resistance exercise (CON RX), indicating a greater metabolic and cardiopulmonary demand during ECC RX.

Participants reported higher levels of soreness and increased inflammatory cytokine TNFα after ECC RX, suggesting that while it may be more effective for muscle engagement, it could also pose a higher risk of discomfort and inflammation, especially for untrained individuals or those with cardiovascular concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Enhanced Eccentric and Concentric Resistance Exercise on Metabolism and Inflammation. Vincent, HK., Percival, S., Creasy, R., et al.[2020]

When exercising at the same perceived exertion level, both treadmills and elliptical devices result in similar oxygen consumption and energy expenditure, making them comparable for cardiovascular workouts.

Despite a higher heart rate observed on the elliptical, the overall effectiveness in terms of oxygen use and energy burned is similar to that of the treadmill, suggesting that ellipticals can be a suitable alternative for cross-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of energy expenditure on a treadmill vs. an elliptical device at a self-selected exercise intensity. Brown, GA., Cook, CM., Krueger, RD., et al.[2016]

Sitting on a stability ball during arm ergometry resulted in a significantly higher peak VO2 (8% to 12% increase) compared to sitting on a chair, indicating a greater metabolic response during exercise.

While heart rate was also higher when using the stability ball at peak exercise levels, the overall impact on heart rate was minimal, suggesting that exercise intensity prescriptions should focus on absolute metabolic levels rather than percentages of maximum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability Ball Sitting Elevates Peak Arm Ergometry Oxygen Consumption and Heart Rate. Marks, CR., Dupuie, L., Patros, J.[2019]

During maximal elliptical crosstrainer (ECT) exercise, heart rate reserve (%HRR) is more closely aligned with the reserve of oxygen uptake (%VO2R) rather than the maximum oxygen uptake (%VO2max), indicating a more accurate measure of exercise intensity.

The relationships between %HRR vs. %VO2R and %HRR vs. %VO2max were found to be equivalent for both ECT and treadmill exercise, suggesting that both modes of exercise yield similar maximal physiological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between %Heart Rate Reserve And %VO2 Reserve During Elliptical Crosstrainer Exercise. Dalleck, LC., Kravitz, L.[2021]

Epidemiologic studies indicate that engaging in vigorous intensity exercise (≥6 METs) significantly reduces the risk of cardiovascular disease more than moderate intensity exercise, suggesting a stronger cardioprotective effect.

Clinical trials show that vigorous intensity exercise (≥60% aerobic capacity) leads to greater improvements in diastolic blood pressure, glucose control, and aerobic capacity compared to moderate intensity exercise, although both intensities have similar effects on systolic blood pressure, lipid profiles, and body fat loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of cardioprotective benefits of vigorous versus moderate intensity aerobic exercise. Swain, DP., Franklin, BA.[2022]

A low-volume resistive exercise protocol significantly increased lactate levels, peaking at 8.54 mM, indicating a strong metabolic response to the exercise.

Despite the rise in lactate, the exercise did not lead to significant changes in peripheral beta-endorphin (B-EN) or cortisol concentrations, suggesting that lactate elevation does not directly influence these hormones in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low-volume resistive exercise on beta-endorphin and cortisol concentrations. Kraemer, RR., Acevedo, EO., Dzewaltowski, D., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3926902/

Feasibility of using a compact elliptical device to increase ... The study found that compact elliptical devices could increase energy expenditure during sedentary activities, with participants expending 87.9 more ...

2. researchgate.net researchgate.net/publication/265055768_Effect_of_Elliptical_High_Intensity_Interval_Training_on_Metabolic_Risk_Factor_in_Pre-_and_Type_2_Diabetes_Patients_A_Pilot_Study

(PDF) Effect of Elliptical High Intensity Interval Training on ... Conclusion: The present study indicates that elliptical HIIT seems to improve metabolic risk factors and body composition in pre- and type 2 ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.008243

Comparative Efficacy of 5 Exercise Types on ... Regarding physical fitness, HYB and CT showed the most advantageous changes in CRF in males (77.4%) and females (77.9%), respectively. CT ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3299003/

Comparison of elliptical training, stationary cycling ... Elliptical training demonstrated greater quadriceps activity and greater quadriceps/hamstrings coactivation than all other conditions.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/21679169.2021.2022756

Metabolic syndrome components response to the ... This randomised-controlled training trial aimed to explore the effect of combined CT + HIIT – conducted on ET – on body mass index (BMI) and MetSyndrome ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3367158/

Impact of Elliptical Trainer Ergonomic Modifications on ... The purpose of this study was to compare, for people with disabilities and chronic conditions, perceptions of safety, comfort, workout, and usability of 4 ...

7. health.clevelandclinic.org health.clevelandclinic.org/elliptical-machine-benefits

10 Elliptical Machine Benefits Elliptical machine benefits include burning calories and improving cardio fitness, while being low-impact and gentle on your joints.

8. healthline.com healthline.com/health/fitness-exercise/elliptical-benefits

Elliptical Benefits: 10 Reasons to Use This Cardio Machine An elliptical machine provides a low impact cardio workout. It can benefit your overall fitness, including increasing your stamina and strengthening your upper ...