An Exercise Intervention to Improve Overall Brain Health

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06035094

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Care Score, Exercise, Hypertension, BMI	Behavioral: Exercise Intervention to improve overall Brain Health	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

Improved overall Brain Care Score metric. [10 consecutive weeks of exercise training]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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, and pass a fitness evaluation.

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pamela G Bowen PhD, CRNP, FNP-BC, BBA, Associate Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT06035094

Other Study ID Numbers:

IRB-300011511
2027708

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pamela G Bowen PhD, CRNP, FNP-BC, BBA, Associate Professor, University of Alabama at Birmingham

Brain health, brain care score. exercise. hypertension, overweight, obesity, BMI

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Sep 13, 2023