An Exercise Intervention to Improve Overall Brain Health

NCT ID: NCT06035094

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2026-01-12

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.

Detailed Description

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Conditions

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Brain Care Score Exercise Hypertension BMI

Keywords

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Brain health brain care score exercise hypertension overweight obesity BMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Intervention to improve overall Brain Health

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Exercise Intervention to improve overall Brain Health

Intervention Type 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.

Control exercise group

Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.

Group Type ACTIVE_COMPARATOR

Exercise Intervention to improve overall Brain Health

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Pamela G Bowen PhD, CRNP, FNP-BC, BBA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela G. Bowen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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2027708

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300011511

Identifier Type: -

Identifier Source: org_study_id