Aerobic Exercise for Vascular Health

(ELEVATE Trial)

Overseen By Claire Cox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Blood pressure, Lipid lowering

Disqualifiers: Diabetes, Hypertension, Cancer, Cardiac, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

242 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise affects blood vessel health in middle-aged and older adults, focusing on differences between men and women. Researchers aim to understand why some individuals benefit more from exercise, potentially leading to personalized exercise recommendations. Participants will either engage in a 12-week aerobic exercise program or continue their usual activities without added exercise. The trial seeks individuals who have been less active (engaging in vigorous activity less than 2 days a week) and are otherwise healthy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to personalized exercise plans for better health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that might influence cardiovascular function, such as blood pressure and lipid-lowering medications, as well as vitamins, supplements, or anti-inflammatory medications at least 1 month before joining the study and for its duration.

What prior data suggests that aerobic exercise training is safe for middle-age and older adults?

Research shows that aerobic exercise, such as walking or cycling, is generally safe for most people. Regular exercise improves heart health and lowers the risk of heart disease. Specifically, at least 150 minutes of moderate exercise each week is linked to better heart function and a reduced risk of disease. Most people can exercise without major issues.

However, paying attention to how the body feels and consulting a doctor before starting a new exercise routine is important, especially for those with health conditions. This study aims to understand how exercise benefits people of different ages and genders, potentially leading to more personalized advice in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise training for vascular health because it offers a natural, non-pharmaceutical approach to improving blood vessel function. Unlike standard treatments that might involve medications like statins or blood pressure drugs, aerobic exercise enhances vascular health by improving blood flow and reducing inflammation through regular physical activity. This method empowers individuals to actively participate in their health management, potentially reducing reliance on medication and encouraging lifestyle changes that can lead to broader health benefits.

What evidence suggests that aerobic exercise is effective for vascular health?

This trial will compare the effects of aerobic exercise training with a control group. Studies have shown that aerobic exercise, such as walking or cycling, can greatly improve heart health. Regular moderate exercise, for instance, can lower the risk of heart diseases. Research suggests that even a 12-week exercise program, similar to the one participants in this trial will undergo, can enhance heart and blood vessel function. One study found that aerobic exercise increases arterial flexibility, benefiting heart health. Overall, aerobic exercise effectively improves blood vessel health, which is crucial for a healthy heart and a longer life. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for middle-aged and older adults who want to participate in a study examining how aerobic exercise affects vascular health differently based on age and sex. Participants will be randomly assigned to either an exercise program or a no-exercise control group for 12 weeks.

Inclusion Criteria

I am willing to participate in either an exercise program or a control group.

Ability to provide consent

I am healthy based on my medical history, physical exam, blood tests, and heart tests.

Exclusion Criteria

Contraindications to aerobic exercise

I have a heart, kidney, or liver condition.

Smoking or tobacco use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including cardiorespiratory fitness, blood pressure, body composition, and collection of biospecimens

1 week

1 visit (in-person)

Treatment

Participants engage in a 12-week aerobic exercise training program or serve as a non-exercise control

12 weeks

3 visits per week (in-person for exercise group)

Follow-up

Participants are monitored for changes in cerebrovascular and endothelial function, and other secondary outcomes

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training

Trial Overview The study is testing the effects of a 12-week aerobic exercise training program compared to no exercise on vascular health in men and women as they age. It aims to understand why people respond differently to exercise due to factors like age and sex.

How Is the Trial Designed?

Group I: Aerobic Exercise Training Experimental Treatment 1 Intervention

Participants randomized to this arm will engage in moderate-intensity aerobic exercise (AE) training program consisting of treadmill walking/running and upright cycling. The training program involves 3 training sessions per week for 12 weeks. Each session will be ≈ 60 minutes in duration. During the 12-week intervention, participants will maintain their typical diet and daily physical activity, aside from the prescribed training program. Participants will periodically check in with the study team to assess any changes in weight and report any changes in their physical activity, diet, or medications.

Group II: Control Active Control 1 Intervention

Participants randomized to this arm will serve as the non-exercise control group. During the 12-week control period, participants will maintain their typical daily physical activity and diet. Participants will periodically check in with the study team to assess any changes in weight and report any changes in their physical activity, diet, or medications.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Aerobic exercise significantly improved cognitive function in a rat model of vascular cognitive impairment (VCI) by shortening the latency in the Water Maze test, indicating enhanced memory and learning capabilities.

The study revealed that exercise modulates the NF-κB/miR-503/BDNF pathway, where exercise downregulates miR-503 and NF-κB, leading to increased levels of BDNF, a protein crucial for neuron survival and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise relieved vascular cognitive impairment via NF-κB/miR-503/BDNF pathway. Niu, Y., Wan, C., Zhou, B., et al.[2020]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

High-intensity aerobic exercise training significantly improves peak oxygen consumption in heart failure patients, with a mean increase of 3.33 ml·kg(-1)·min(-1), which is a 23% improvement from baseline, compared to control groups.

No deaths were reported as directly attributable to exercise during the study, indicating that higher exercise intensity can be safely implemented in heart failure rehabilitation without increasing mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and cardiovascular responses to different exercise training intensities in patients with heart failure: a systematic review and meta-analysis. Ismail, H., McFarlane, JR., Nojoumian, AH., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6557987/

Effects of Exercise to Improve Cardiovascular Health - PMC These studies indicate that both moderate and high intensity exercise training improve cardiovascular function in heart failure patients, ...

2. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.112.123117

Cardiovascular Risk of High- Versus Moderate-Intensity ... The results of the current study indicate that the risk of a cardiovascular event is low after both high-intensity exercise and moderate-intensity exercise.

3. ama-assn.org ama-assn.org/public-health/prevention-wellness/massive-study-uncovers-how-much-exercise-needed-live-longer

Massive study uncovers how much exercise is needed to ... Meeting the minimum for moderate and vigorous activity can reduce cardiovascular disease mortality by 22% to 31%. A separate study published in JAMA Oncology ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2022.07.004

Exercise for CVD Prevention: JACC Focus Seminar 1/4 In a recent meta-analysis, aerobic exercise training (≥4 weeks duration) was associated with a significant reduction of 0.76 m/s for pulse wave velocity ( ...

5. academic.oup.com academic.oup.com/eurheartj/article/45/13/1127/7513891

Aerobic, resistance, or combined exercise & cardiovascular risk Some trials demonstrated the superior health benefits of combined resistance plus aerobic exercise than either exercise alone on frailty in ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

7. heart.org heart.org/en/healthy-living/fitness/fitness-basics/aha-recs-for-physical-activity-in-adults

AHA Physical Activity Recommendations ... Recommendations for Adults. Get at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic ...