An Exercise Intervention to Improve Overall Brain Health

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question[s] it aims to answer are: To test the effect of moderate vs intensive exercise on Brain Care Score outcomes. To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.

Official Title
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An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study

Conditions
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BMI, Brain Care Score, Exercise, Hypertension

Intervention / Treatment
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* Behavioral: Exercise Intervention to improve overall Brain Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with hypertension have a body mass index ≥ 25 kg/m2 are between the ages of 35-65 years old access to a smart phone that allows installation of 2 two applications that record your workouts pass a fitness evaluation. Exclusion Criteria: do not have hypertension weight over 300 lbs unable to pass the fitness evaluation BMI less than 25kg/m2

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training (HIIT) exercise group,<br>Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol. | Behavioral: Exercise Intervention to improve overall Brain Health<br>* During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity zones. The participant will receive training on how to use the outlined schedule during the initial supervised training session.<br>|
| Experimental: Moderate Intensity Training (MIT) exercise group<br>Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol. | Behavioral: Exercise Intervention to improve overall Brain Health<br>* During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity zones. The participant will receive training on how to use the outlined schedule during the initial supervised training session.<br>|
| Active Comparator: Control exercise group<br>Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise. | Behavioral: Exercise Intervention to improve overall Brain Health<br>* During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity zones. The participant will receive training on how to use the outlined schedule during the initial supervised training session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved overall Brain Care Score metric. | The score is based on lifestyle categories on a scale of 0-21 where 21 is best. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, hypertension, overweight, obesity, BMI, Brain health, brain care score