An Exercise Intervention to Improve Overall Brain Health

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.

Completed

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Key information

Conditions

Brain Care Score BMI Behavior Body Weight Cardiovascular Diseases Exercise Hypertension Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention to improve overall Brain Health

Behavioral

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.

Primary outcomes

Improved overall Brain Care Score metric.

Time frame: 10 weeks

The score is based on lifestyle categories on a scale of 0-21 where 21 is best.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 13, 2023
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed