Physical Activity for Health

(MoTrPAC Trial)

No longer recruiting at 10 trial locations

Overseen By Cindy Stowe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Beta blockers, Anticoagulants, Antipsychotics, others

Disqualifiers: Diabetes, Thyroid disease, COPD, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of physical activity—endurance and resistance exercises—affect the body's molecules and how these changes might lead to health benefits. Participants will be divided into groups: some will focus on endurance exercises, others on resistance training, and some will not exercise. The goal is to map the body's molecular responses to exercise, potentially helping scientists understand and improve the health benefits of physical activity in the future. The trial seeks adults who are either very active or consider themselves sedentary, meaning they don't engage in structured exercise more than once a week. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding of exercise and health.

Will I have to stop taking my current medications?

The trial requires that participants do not have any changes in their chronic-use medications in the last 3 months and excludes those using certain medications like beta blockers, anticoagulants, and chronic oral steroids. If you're on any of these medications, you may need to stop or adjust them before participating.

What prior data suggests that these exercise protocols are safe?

Research has shown that both endurance and resistance training are generally safe and well-tolerated. For endurance training, studies indicate that moderate exercise benefits heart health and is safe when performed for about 30 minutes, 4 to 5 times a week. However, very intense endurance exercise might temporarily strain the heart, especially on the right side, though it usually recovers quickly.

Resistance training is also safe and effective, helping to build muscle and improve strength for both young people and older adults. Research has shown it can enhance heart health and physical ability. To ensure safety, proper form and the right amount of weight are important.

In summary, both types of exercise are safe when done correctly. Starting slowly and gradually increasing intensity helps avoid injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore how different types of physical activity can impact health, particularly in contrast to a sedentary lifestyle. Unlike many common approaches that often focus on pharmaceuticals or dietary changes, this trial highlights endurance and resistance training as direct interventions. By comparing highly active individuals with those who are sedentary, the study hopes to uncover more about the immediate and long-term benefits of physical activity. This could lead to a better understanding of how exercise routines can be optimized for health improvements, offering a natural and accessible alternative to traditional treatments.

What evidence suggests that this trial's treatments could be effective?

This trial will compare different exercise regimens. Studies have shown that endurance exercises, such as cycling or running, improve heart health, increase stamina, and lower the risk of diseases like heart disease and diabetes. Research also suggests these activities help maintain a healthy weight and boost overall fitness. Participants in this trial may engage in endurance exercises as part of the study.

Conversely, resistance exercises, like weight lifting, strengthen muscles and bones, improve joint function, and help control blood sugar levels. They can also reduce the risk of long-term conditions such as arthritis and heart disease. Some participants in this trial will engage in resistance exercises. Both types of exercise benefit overall health and can enhance physical performance and independence in daily activities. ^{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?

Adults aged 18+ who can read and speak English, are willing to consent, and have a BMI between 19-35 kg/m2. Participants should be either sedentary (exercising no more than once a week) or highly active in endurance or resistance training for over a year. Those with certain chronic diseases, recent drug use that affects exercise response, or planning significant weight changes are excluded.

Inclusion Criteria

Only one member of a household can participate

Willingness to include de-identified individual-level data at low risk of re-identification in the MoTrPAC open-access database

Persons bicycling as a mode of transportation to and from work >1 day/week etc. are not considered sedentary

Exclusion Criteria

I have reported lung problems.

I have a bone condition that affects how my bones use minerals.

Other (clinician judgement)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to endurance exercise, resistance exercise, or no exercise control for approximately 12 weeks. Assessments include cardiorespiratory fitness, muscular strength, and body composition.

12 weeks

Multiple visits for assessments and biospecimen collection

Follow-up

Participants are monitored for changes in CPET VO2 Peak, isometric knee peak torque, and various blood markers.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endurance Training
• Restistance Training

Trial Overview

The MoTrPAC study is testing how the body's molecules respond to different types of physical activity. Adults will do endurance training (like running), resistance training (like lifting weights), or no exercise at all for about 12 weeks while scientists observe molecular changes.

How Is the Trial Designed?

Group I: Highly Active EE Active Control 1 Intervention

A comparison group of highly active EE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants are tested on a cycle ergometer.

Group II: Sedentary RE Active Control 1 Intervention

Participants randomized to RE first engage in a single acute exercise test of Resistance Exerciser, consistent with their random assignment.

Group III: Highly Active RE Active Control 1 Intervention

A comparison group of highly active RE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants are tested via a bout of resistance exercise.

Group IV: Sedentary control Active Control 1 Intervention

The control group does not engage in any acute exercise testing protocol, but biospecimens are collected prior to and following a period of rest.

Group V: Sedentary EE Active Control 1 Intervention

Participants randomized to EE first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.

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+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Broad Institute

Collaborator

Trials

21

Recruited

16,300+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Dynamic resistance training can be safely included in cardiac rehabilitation for selected patients, as it does not pose a higher risk than aerobic training when properly supervised and tailored to individual needs.

Low-intensity resistance training (40-60% of maximum voluntary contraction) with controlled repetitions leads to only modest increases in blood pressure, similar to moderate endurance training, making it a viable option for improving muscle strength and cardiovascular health in patients with good cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. Bjarnason-Wehrens, B., Mayer-Berger, W., Meister, ER., et al.[2019]

The recent deaths of two healthy Canadian physicians during running highlight the need to reassess the risks of major cardiovascular events in fit individuals engaging in long-distance running.

Physicians must inform patients about the rare but serious risks associated with running, as mandated by a Supreme Court ruling, emphasizing the importance of further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MACE in the Race: A Canadian Perspective on Major Adverse Cardiac Events (MACE) During Running. Abrahim, M.[2022]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

Strength training is beneficial for patients with various cardiovascular and metabolic diseases, showing improvements in muscle strength, quality of life, and mobility, especially in older individuals.

Resistance training is considered safe and can be recommended for a broad range of patients, including those with reduced left ventricular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Resistance training for patients with cardiovascular diseases]. Wonisch, M., Marko, C., Niebauer, J., et al.[2021]

In a review of 121 trials involving 6700 older adults, most adverse events related to progressive resistance strength training were musculoskeletal issues like muscle strains and joint pain, particularly in participants with pre-existing health conditions or those engaging in high-intensity training.

Adverse events were often underreported, highlighting the need for clearer definitions and consistent reporting in future studies to better inform practitioners about the risks and benefits of strength training in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Liu, CJ., Latham, N.[2010]

Recent studies indicate that resistance exercise, when performed at low intensities (40-60% of maximum voluntary contraction) and with high repetitions (15-20), can lead to only moderate increases in blood pressure, similar to those seen with moderate aerobic training.

Resistance training can be beneficial for certain cardiac patients, improving muscle strength, cardiovascular function, and overall quality of life, but it should be tailored to individual clinical statuses, particularly for those with high physical capacity and good myocardial function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The stakes of force perseverance training and muscle structure training in rehabilitation. Recommendations of the German Federation for Prevention and Rehabilitation of Heart-Circulatory Diseases e.v]. Bjarnason-Wehrens, B., Mayer-Berger, W., Meister, ER., et al.[2007]

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]

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]

Engaging in just 30 minutes of moderate-intensity physical activity daily can lead to significant health benefits, highlighting the importance of regular exercise for overall health.

The 'Physical Activity Pyramid' suggests that while moderate exercise is foundational, incorporating cardiorespiratory fitness, strength training, and stretching can provide even greater health advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise and sports: an undervalued health resource]. Martin, BW., Marti, B.[2008]

Regular exercise can significantly enhance fitness levels for individuals of all ages, contributing to better weight management, improved lipid profiles, and enhanced carbohydrate tolerance.

While exercise is generally beneficial, it is important to prescribe it carefully to minimize risks, particularly the potential for cardiovascular events during intense physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy exercise. Oberman, A.[2018]

In a study of 75 heart failure patients post-PCI, both combined endurance-resistance training (CT) and endurance training (ET) significantly improved functional capacity and reduced NT-pro BNP levels, indicating enhanced heart function.

CT and ET were equally effective in improving cardiovascular markers, demonstrating that exercise training is safe and beneficial for heart failure patients, even those with reduced ejection fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of combined endurance-resistance training versus endurance training in patients with heart failure after percutaneous coronary intervention: A randomized controlled trial. Abolahrari-Shirazi, S., Kojuri, J., Bagheri, Z., et al.[2022]

Endurance training is crucial for heart health as it leads to metabolic and hemodynamic adaptations that lower the heart's oxygen demand and improve blood flow properties, which can help prevent cardiovascular issues.

The training also positively affects lipoprotein metabolism, potentially offering protection against arteriosclerosis, and the paper suggests a minimum training program based on practical experience to achieve these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in the prevention of ischaemic heart disease. Hollmann, W.[2008]

Endurance exercise training leads to significant metabolic adaptations, such as increased mitochondrial size and number in skeletal muscles, improved fatty acid oxidation, and higher glycogen storage, enhancing overall energy production.

Cardiovascular benefits include lower resting heart rates, increased stroke volume, and improved VO2max, which collectively reduce the risk of coronary artery disease and improve overall cardiovascular fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise physiology and cardiovascular fitness. Braun, LT.[2008]

Physical inactivity, often linked to malnutrition, is a significant risk factor for various diseases, particularly affecting children and adolescents, highlighting the urgent need for preventive strategies.

Regular physical activity, especially moderate endurance exercises like walking or cycling for 30-60 minutes at least twice a week, is crucial for maintaining both physical and psychological health throughout life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of physical activity on human health]. Predel, HG., Tokarski, W.[2016]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

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