NCT06753253

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 5, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self-Reported Executive Function

    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

    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

    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.

Study Arms (3)

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.

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.

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.

Behavioral: Cycling Exercise

Interventions

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.

High-IntensityLow IntensityModerate Intensity

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 31, 2024

Study Start

August 6, 2024

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations