Back to results

An Exercise Intervention to Improve Overall Brain Health

Primary Purpose

Brain Care Score, Exercise, Hypertension

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention to improve overall Brain Health

About this trial

This is an interventional prevention trial for Brain Care Score focused on measuring Brain health, brain care score, exercise, hypertension, overweight, obesity, BMI

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training (HIIT) exercise group,

Moderate Intensity Training (MIT) exercise group

Control exercise group

Arm Description

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.

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

Outcomes

Primary Outcome Measures

Improved overall Brain Care Score metric.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT06035094

First Posted

September 6, 2023

Last Updated

September 15, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT06035094

Brief Title

An Exercise Intervention to Improve Overall Brain Health

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Care Score, Exercise, Hypertension, BMI

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Interval Training (HIIT) exercise group,

Arm Type

Experimental

Arm Description

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.

Arm Title

Moderate Intensity Training (MIT) exercise group

Arm Type

Experimental

Arm Description

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.

Arm Title

Control exercise group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention to improve overall Brain Health

Intervention Description

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 Outcome Measure Information:

Title

Improved overall Brain Care Score metric.

Description

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

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela G. Bowen, PhD

Phone

2054472343

pbowen@uab.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tasha Smith, PhD

Phone

2059348155

tasharsmith@uabmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela G. Bowen, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamela G. Bowen, PhD

Phone

205-934-2778

pbowen@uab.edu

First Name & Middle Initial & Last Name & Degree

Tasha Smith, PhD

Phone

2059348155

tasharsmith@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Pamela G. Bowen, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Exercise Intervention to Improve Overall Brain Health

We'll reach out to this number within 24 hrs