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Clinical Trials/NCT06035094
NCT06035094
Completed
N/A

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

University of Alabama at Birmingham1 site in 1 country35 target enrollmentJanuary 23, 2024

Overview

Phase
N/A
Intervention
Exercise Intervention to improve overall Brain Health
Conditions
Brain Care Score
Sponsor
University of Alabama at Birmingham
Enrollment
35
Locations
1
Primary Endpoint
Improved overall Brain Care Score metric.
Status
Completed
Last Updated
3 months ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 23, 2024
End Date
January 12, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Associate Professor

University of Alabama at Birmingham

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Exercise Intervention to improve overall Brain Health

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.

Intervention: Exercise Intervention to improve overall Brain Health

Control exercise group

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

Intervention: Exercise Intervention to improve overall Brain Health

Outcomes

Primary Outcomes

Improved overall Brain Care Score metric.

Time Frame: 10 weeks

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

Study Sites (1)

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