An Exercise Intervention to Improve Overall Brain Health

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; BMI; Exercise; Brain Care Score
• Intervention / Treatment: Behavioral: Exercise Intervention to improve overall Brain Health

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Interval Training (HIIT) exercise group,; 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; 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.
Experimental: Moderate Intensity Training (MIT) exercise group; 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; 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.
Active Comparator: Control exercise group; Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.	Behavioral: Exercise Intervention to improve overall Brain Health; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Pamela G. Bowen, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: exercise; obesity; overweight; hypertension; BMI; Brain health; brain care score
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Motor Activity
• Other Study ID Numbers: IRB-300011511; 2027708 (Other Grant/Funding Number: McCance/ UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No