Physical Activity for Health

(MoTrPAC Trial)

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

2280 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess molecular changes that occur in response to physical activity (PA). To achieve this aim, a mechanistic randomized controlled trial (RCT) is conducted, in which adult study participants are randomized to endurance exercise (EE) training, resistance exercise (RE) training, or no exercise Control for a period of approximately 12 weeks. The overarching hypothesis is that there are discoverable molecular transducers that communicate and coordinate the effects of exercise on cells, tissues, and organs, which may initiate processes ultimately leading to the health benefits of exercise. Because this is a mechanistic trial, the main goal is not a single health-related outcome. Rather, the goal is to generate a resource leading to the generation of a map of the molecular responses to exercise that will be used by the Consortium and by the scientific community at large to generate hypotheses for future investigations of the health benefits of PA.

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 evidence supports the effectiveness of the treatment involving endurance and resistance training for cardiovascular health?

Research shows that both endurance and resistance training can improve heart health by increasing physical performance, enhancing quality of life, and reducing risk factors for heart disease. These exercises are safe and beneficial for many patients, including those with heart conditions, when tailored to individual needs and supervised by professionals. ^{1 2 3 4 5}

Is physical activity, like resistance and endurance training, generally safe for humans?

Physical activity, including resistance and endurance training, is generally safe for most people, but there are some risks, especially for those with certain health conditions. Resistance training can cause adverse events, particularly in people with chronic health issues, and may lead to increased blood pressure in cardiac patients if not properly supervised. However, when done correctly and under medical supervision, it can be as safe as aerobic exercise and beneficial for muscle strength and cardiovascular health. ^{6 7 8 9 10}

How does the treatment of endurance and resistance training differ from other treatments for improving cardiovascular health?

Endurance and resistance training are unique because they improve cardiovascular health by enhancing the heart's efficiency and increasing the body's ability to use oxygen, unlike other treatments that may focus solely on medication. This type of exercise also helps reduce risk factors like high blood pressure and cholesterol, offering a holistic approach to heart health. ^{11 12 13 14 15}

Research Team

Mike E Miller, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Sport and exercise in prevention and therapy of cardiovascular diseases]. [2021]

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

[Resistance training for patients with cardiovascular diseases]. [2021]

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

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. [2019]

4. India 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. [2008]

6. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

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

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

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

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

9. Germany 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]. [2007]

10. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

11. Finland pubmed.ncbi.nlm.nih.gov

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

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

Exercise physiology and cardiovascular fitness. [2008]

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Exercise and sports: an undervalued health resource]. [2008]

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

Healthy exercise. [2018]

15. Germany pubmed.ncbi.nlm.nih.gov

[Influence of physical activity on human health]. [2016]