Brain Care ScoreNCT06035094
An Exercise Intervention to Improve Overall Brain Health
A study testing Exercise Intervention to improve overall Brain Health in people with Brain Care Score and Exercise, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Care Score, Exercise, Hypertension
- What is being tested?
- Exercise Intervention to improve overall Brain Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- do not have hypertension
- weight over 300 lbs
- unable to pass the fitness evaluation
- BMI less than 25kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study
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.
- Conditions
- Brain Care Score, Exercise, Hypertension, BMI
- Being tested
- Exercise Intervention to improve overall Brain Health
- Keywords
- Brain health, brain care score, exercise, hypertension, overweight, obesity, BMI
- Medical subject headings
- Motor Activity, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention to improve overall Brain HealthBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Exercise Intervention to improve overall Brain Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved overall Brain Care Score metric.
The score is based on lifestyle categories on a scale of 0-21 where 21 is best.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start23 Jan 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Care ScoreStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela G Bowen PhD, CRNP, FNP-BC, BBA, University of Alabama at Birmingham
- Investigators
- Pamela G. Bowen, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035094
- Sponsor's protocol ID
- IRB-300011511
- Other IDs
- 2027708
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study
- ClinicalTrials.gov ID
- NCT06035094
- Acronym / sponsor ID
- IRB-300011511
- Conditions
- Brain Care Score, Exercise, Hypertension, BMI
- Keywords
- Brain health, brain care score, exercise, hypertension, overweight, obesity, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) exercise group, | Experimental | Behavioral: Exercise Intervention to improve overall Brain HealthParticipants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol. |
| Moderate Intensity Training (MIT) exercise group | Experimental | Behavioral: Exercise Intervention to improve overall Brain HealthParticipants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol. |
| Control exercise group | Active comparator | Behavioral: Exercise Intervention to improve overall Brain HealthParticipants will be advised to follow the American Heart Association (AHA) guidelines on exercise. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- do not have hypertension
- weight over 300 lbs
- unable to pass the fitness evaluation
- BMI less than 25kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Intervention to improve overall Brain HealthDuring 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. | Behavioural | Control exercise group, High Intensity Interval Training (HIIT) exercise group,, Moderate Intensity Training (MIT) exercise group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela G. Bowen, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention to improve overall Brain Health in people with Brain Care Score and Exercise, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved overall Brain Care Score metric. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.