An Exercise Intervention to Improve Overall Brain Health

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06035094

Enrollment

Registered

2023-09-13

Start date

2024-01-23

Completion date

2026-01-12

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BMI, Brain Care Score, Exercise, Hypertension

Keywords

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

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.

Interventions

BEHAVIORALExercise 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Improved overall Brain Care Score metric.	10 weeks	The score is based on lifestyle categories on a scale of 0-21 where 21 is best.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026