Exercise for High Blood Pressure

(XTIME Trial)

Overseen By Thomas Keiser

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Freda Patterson

Must not be taking: Sleep medications, Antihypertensives

Disqualifiers: Chronic disease, Sleep disorder, others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the timing of exercise affects blood pressure in individuals with slightly high blood pressure (between 120/80 and 140/90 mmHg). It will test exercising in the morning, afternoon, and evening to determine which time of day best lowers blood pressure over the next 24 hours. Suitable participants have slightly high blood pressure, do not have chronic diseases or sleep disorders, and are not very physically active. As an unphased trial, this study provides an opportunity to contribute to understanding how exercise timing can optimize blood pressure management.

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect blood pressure or vascular health, you will need to stop, as the trial excludes those using such medications.

What prior data suggests that this exercise protocol is safe for adults with high blood pressure?

Research has shown that exercise is generally safe for most people and can lower blood pressure while offering many health benefits. Studies indicate that a single exercise session can reduce the systolic blood pressure, regardless of the time of day. Morning exercise can lower blood pressure for up to 8 hours in older adults. Afternoon workouts might reduce blood pressure more effectively than morning ones, and evening exercise is also associated with lower blood pressure. Overall, the benefits of exercise greatly outweigh any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise to manage high blood pressure because it offers a drug-free approach that targets the body's natural processes. Unlike medications such as ACE inhibitors, beta blockers, or diuretics, exercise can improve cardiovascular health without the side effects associated with pharmaceuticals. This trial is exploring whether exercising at different times in relation to melatonin onset—morning, afternoon, or evening—can enhance these benefits. By pinpointing the most effective time of day for exercise, researchers hope to optimize its impact on blood pressure, potentially offering a personalized and accessible method for managing hypertension.

What evidence suggests that exercise might be an effective treatment for high blood pressure?

This trial will compare the effects of exercise at different times of day on high blood pressure. Studies have shown that regular exercise effectively lowers blood pressure. Research indicates that physical activity, regardless of the time of day, helps reduce both systolic (the top number) and diastolic (the bottom number) blood pressure. Participants in the morning exercise group may benefit from evidence supporting reduced heart-related risks and lowered blood pressure. Those in the afternoon exercise group may see significant reductions in diastolic pressure. Participants in the evening exercise group may experience maintained lower blood pressure over time. Overall, adding exercise to a daily routine can be a powerful way to manage high blood pressure. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for young adults with elevated or high blood pressure who are interested in how exercise timing affects their condition. Participants should have a stable schedule and be willing to undergo treadmill exercises at specific times based on their biological rhythm.

Inclusion Criteria

Resting blood pressure greater than or equal to 120/80 mmHg or less than 140/90 mmHg

I am between 18 and 39 years old.

Exclusion Criteria

Elevated risk for clinical depression

I have a chronic or autoimmune disease.

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biological Rhythm Assessment

Participants undergo an in-lab assessment of individual biological rhythm to determine the clock-time for an individual's biological night

1 week

1 visit (in-person)

Exercise Sessions

Participants complete 3 supervised treadmill exercise sessions at different times of day (morning, afternoon, evening) based on their biological night

3 weeks

3 visits (in-person)

Blood Pressure Assessment

Participants complete a 24-hour blood pressure assessment before and after each exercise session

3 weeks

Follow-up

Participants are monitored for changes in average daytime systolic blood pressure post-exercise

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study tests the effects of exercising at different times (morning, afternoon, evening) on blood pressure over 24 hours. It involves an initial assessment of each participant's biological night followed by three supervised treadmill sessions timed according to this internal clock.

How Is the Trial Designed?

Group I: Morning Experimental Treatment 1 Intervention

Exercise 10 hours after dim-light melatonin onset

Group II: Evening Experimental Treatment 1 Intervention

Exercise 20 hours after dim-light melatonin onset

Group III: Afternoon Experimental Treatment 1 Intervention

Exercise 15 hours after dim-light melatonin onset

Who Is Running the Clinical Trial?

Freda Patterson

Lead Sponsor

Citations

1. nature.com nature.com/articles/s41598-023-37149-2

Effect of leisure-time physical activity on blood pressure in ... Performing physical activity during free time probably reduces SBP and DBP (low certainty of the evidence) among adults with hypertension.

2. clinicalhypertension.biomedcentral.com clinicalhypertension.biomedcentral.com/articles/10.1186/s40885-024-00281-w

The effect of physical activity intervention on blood pressure in ... Additionally, PA was found to have a significant influence on reducing diastolic blood pressure (DBP), as indicated by a WMD of -3.60 mmHg, with ...

3. bjsm.bmj.com bjsm.bmj.com/content/57/20/1317

Exercise training and resting blood pressure: a large-scale ... Overall, isometric exercise training is the most effective mode in reducing both systolic and diastolic blood pressure. These findings provide a comprehensive ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4624627/

Influence of Physical Activity on Hypertension and Cardiac ... Regular physical activity is associated with lower blood pressure, reduced cardiovascular risk, and cardiac remodeling.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2095254624000048

The effectiveness of physical activity interventions on blood ... PA combined with nutrition and behavior change was the most effective intervention for reducing both systolic BP and diastolic BP.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37948020/

Effects of the Timing of Intense Physical Activity on ... We found that the risk of developing hypertension over time was reduced for patients who performed exercise earlier in the morning than at other times of the ...

7. nature.com nature.com/articles/s41371-024-00929-y

Exercise time of day and blood pressure Nevertheless, the health benefit may be outcome-specific as other work suggests afternoon exercise may be best for glucose regulation [13, 14].

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

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

9. sciencedirect.com sciencedirect.com/science/article/pii/S1440244023000427

Time of the day of exercise impact on cardiovascular ... Afternoon aerobic exercise decreased greater mean and systolic blood pressure compared to morning exercise. This diurnal variation was less marked following ...

10. acc.org acc.org/latest-in-cardiology/journal-scans/2019/05/16/12/40/morning-versus-evening-aerobic-training-effects-on-bp-in-treated-htn

Morning Versus Evening Aerobic Training Effects on BP ... Aerobic training performed in either morning or evening reduces SVR and increases baroreflex sensitivity, though effects are greater with ET.