- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06753253
Effects of Exercise Intensity on ADHD Symptoms
December 20, 2024 updated by: Kent State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Kent, Ohio, United States, 44242
- Kent State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Intensity
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.
|
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.
|
|
Experimental: Moderate Intensity
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.
|
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.
|
|
Experimental: High-Intensity
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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)
|
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
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)
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2024
Primary Completion (Actual)
November 25, 2024
Study Completion (Actual)
November 25, 2024
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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