Attention Deficit Disorder with HyperactivityNCT06753253
Effects of Exercise Intensity on ADHD Symptoms
A study testing Cycling Exercise in people with Attention Deficit Disorder with Hyperactivity and Attention Deficit Hyperactivity Disorder, run by Kent State University at 1 site in United States.
Trial summary
This project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (ADHD) in college students. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder, ADHD
- What is being tested?
- Cycling Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2024to 25 Nov 2024
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University
Who cannot join
- seizures/epilepsy syncope asthma chronic obstructive pulmonary disease (COPD) restrictive lung disease adult respiratory distress syndrome (ARDS) heart problems/defects/heart failure/valve problems liver/kidney disease diabetes mellitus current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low, Moderate, and High Intensity Exercise on Executive Function, Functional Impairment, and Symptom Severity in ADHD
This project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (ADHD) in college students. Specifically, the outcomes of interest in this study are self-reported executive functioning, self-reported functional impairment, and ADHD symptom severity. The hypothesis is that exercise will improve executive functioning, while reducing functional impairment and ADHD symptom severity, and that this response will be most pronounced in the high-intensity exercise group.
- Conditions
- Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder, ADHD
- Being tested
- Cycling Exercise
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling ExerciseBehavioural
Each arm will perform a 20-minute cycling intervention on an airdyne bike at different exercise intensity levels. Participants will perform the intervention three times over the course of one week.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity | Experimental | The low intensity arm will perform 20 minutes of steady-state cycling on an airdyne bike. Intensity will be confirmed with continuous heart rate measurement, and heart rate should not exceed 65% of maximal heart rate (220-age) in this arm. Receives: Behavioral: Cycling Exercise |
| Moderate Intensity | Experimental | The moderate intensity arm will perform 20 minutes of steady-state cycling on an airdyne bike, maintaining heart rate between 65-85% of maximal heart rate. Receives: Behavioral: Cycling Exercise |
| High-Intensity | Experimental | The high-intensity arm will perform a 3-minute steady-state cycling warm up on an airdyne bike, followed by 16 minutes of high intensity interval training (HIIT) cycling. The HIIT protocol consists of alternating periods of 20 seconds of high-intensity effort and 120 seconds of return to low-intensity steady-state cycling. The heart rate goal to ensure high-intensity effort is to maintain heart rate > 85% maximal heart rate during the 20 second high-intensity bursts. Receives: Behavioral: Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Executive Function
Self-reported executive function will be measured using a modified version of the Barkley Executive Function Scale (BDEFS)
Measured: The BDEFS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Self-Reported Functional Impairment
Self-Reported Functional Impairment will be measured using a modified version of the Barkley Functional Impairment Scale (BFIS)
Measured: The BFIS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Self-Reported ADHD Symptom Severity
Self-Reported ADHD Symptom Severity will be measured using the Barkley Adult ADHD Rating Scale IV (BAARS-IV)
Measured: The BAARS-IV will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start6 Aug 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder with HyperactivityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753253
- Sponsor's protocol ID
- 1265
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edmondson ME, Ridgel AL. Effects of Low, Moderate, and High Intensity Exercise on Functional Impairment and ADHD Symptoms: A Randomized Pilot Study. West J Nurs Res. 2026 Sep;48(9):980-987. doi: 10.1177/01939459261458869. Epub 2026 Jul 12.
PubMed 42437494
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low, Moderate, and High Intensity Exercise on Executive Function, Functional Impairment, and Symptom Severity in ADHD
- ClinicalTrials.gov ID
- NCT06753253
- Acronym / sponsor ID
- 1265
- Conditions
- Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 31 Dec 2024 (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.
This project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (ADHD) in college students. Specifically, the outcomes of interest in this study are self-reported executive functioning, self-reported functional impairment, and ADHD symptom severity. The hypothesis is that exercise will improve executive functioning, while reducing functional impairment and ADHD symptom severity, and that this response will be most pronounced in the high-intensity exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Intensity | Experimental | Behavioral: Cycling ExerciseThe low intensity arm will perform 20 minutes of steady-state cycling on an airdyne bike. Intensity will be confirmed with continuous heart rate measurement, and heart rate should not exceed 65% of maximal heart rate (220-age) in this arm. |
| Moderate Intensity | Experimental | Behavioral: Cycling ExerciseThe moderate intensity arm will perform 20 minutes of steady-state cycling on an airdyne bike, maintaining heart rate between 65-85% of maximal heart rate. |
| High-Intensity | Experimental | Behavioral: Cycling ExerciseThe high-intensity arm will perform a 3-minute steady-state cycling warm up on an airdyne bike, followed by 16 minutes of high intensity interval training (HIIT) cycling. The HIIT protocol consists of alternating periods of 20 seconds of high-intensity effort and 120 seconds of return to low-intensity steady-state cycling. The heart rate goal to ensure high-intensity effort is to maintain heart rate > 85% maximal heart rate during the 20 second high-intensity bursts. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University
Key exclusion criteria (1 listed)
- seizures/epilepsy syncope asthma chronic obstructive pulmonary disease (COPD) restrictive lung disease adult respiratory distress syndrome (ARDS) heart problems/defects/heart failure/valve problems liver/kidney disease diabetes mellitus current pregnancy
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 |
|---|---|---|
| Cycling ExerciseEach arm will perform a 20-minute cycling intervention on an airdyne bike at different exercise intensity levels. Participants will perform the intervention three times over the course of one week. | Behavioural | High-Intensity, Low Intensity, Moderate Intensity |
Primary outcome
Self-Reported Executive Function
Time frame: The BDEFS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Self-reported executive function will be measured using a modified version of the Barkley Executive Function Scale (BDEFS)
Self-Reported Functional Impairment
Time frame: The BFIS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Self-Reported Functional Impairment will be measured using a modified version of the Barkley Functional Impairment Scale (BFIS)
Self-Reported ADHD Symptom Severity
Time frame: The BAARS-IV will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Self-Reported ADHD Symptom Severity will be measured using the Barkley Adult ADHD Rating Scale IV (BAARS-IV)
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 31 Dec 2024.
- Derived from this study: PubMed 42437494Edmondson ME, Ridgel AL. Effects of Low, Moderate, and High Intensity Exercise on Functional Impairment and ADHD Symptoms: A Randomized Pilot Study. West J Nurs Res. 2026 Sep;48(9):980-987. doi: 10.1177/01939459261458869. Epub 2026 Jul 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling Exercise in people with Attention Deficit Disorder with Hyperactivity and Attention Deficit Hyperactivity Disorder, run by Kent State University 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 1 inclusion and 1 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 31 Dec 2024. 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?
Self-Reported Executive Function (time frame: The BDEFS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753253, which also lists 1 linked publication.
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 31 Dec 2024.