NCT06035094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

September 6, 2023

Last Update Submit

January 12, 2026

Conditions

Brain Care ScoreExerciseHypertensionBMI

Keywords

Brain healthbrain care scoreexercisehypertensionoverweightobesityBMI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

High Intensity Interval Training (HIIT) exercise group,

EXPERIMENTAL

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

Moderate Intensity Training (MIT) exercise group

EXPERIMENTAL

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

Control exercise group

ACTIVE COMPARATOR

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

Behavioral: Exercise Intervention to improve overall Brain Health

Interventions

Exercise Intervention to improve overall Brain HealthBEHAVIORAL

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 groupHigh Intensity Interval Training (HIIT) exercise group,Moderate Intensity Training (MIT) exercise group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • do not have hypertension
  • weight over 300 lbs
  • unable to pass the fitness evaluation
  • BMI less than 25kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor ActivityHypertensionOverweightObesity

Condition Hierarchy (Ancestors)

BehaviorVascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela G. Bowen, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

January 23, 2024

Primary Completion

January 12, 2026

Study Completion

January 12, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)