Aerobic Exercise only for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Attention Deficit Hyperactivity Disorder (ADHD)+2 More
Aerobic Exercise - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this project is to evaluate the effectiveness of a structured aerobic exercise intervention for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) with and without medication and compare it to medication alone. Participants will be randomly assigned to medication only + education, aerobic exercise intervention only, and combined aerobic exercise and medication groups. Participants will be evaluated at baseline, following medication optimization (for medicated groups), following 8 weeks of intervention, after 3 months of follow-up, and after 6 months of follow-up. The investigators hypothesize that the combined group will have the best outcome at all evaluation points and that treatment gains will be maintained throughout the follow-up period if the assigned treatments are continued.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Attention Deficit Hyperactivity Disorder (ADHD)

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Completed before each medication visit, every 1 - 2 weeks up to 6 weeks.

Month 6
Anxiety Symptoms (measured via the Beck Anxiety Inventory) - Change from baseline
Depression symptoms (via the Beck Depression Inventory) - Change from baseline
Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline
Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline
Motivation to exercise (measured via the Physical Activity and Leisure Motivation Scale) - Change from baseline
Self-esteem (measured via the Index of Self-Esteem) - Change from baseline
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline
Week 6
Stimulant medication side effects (measured via the Canadian ADHD Resource Alliance (CADDRA) Patient ADHD Medication Form)

Trial Safety

Safety Progress

1 of 3

Other trials for Attention Deficit Hyperactivity Disorder (ADHD)

Side Effects for

Standard Care Plus Exercise Program
1%Malignant melanoma
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT01065506) in the Standard Care Plus Exercise Program ARM group. Side effects include: Malignant melanoma with 1%.

Trial Design

3 Treatment Groups

Combination Group
1 of 3
Medication only
1 of 3
Aerobic Exercise only
1 of 3
Active Control
Experimental Treatment

70 Total Participants · 3 Treatment Groups

Primary Treatment: Aerobic Exercise only · No Placebo Group · N/A

Aerobic Exercise only
Behavioral
Experimental Group · 1 Intervention: Aerobic Exercise · Intervention Types: Behavioral
Combination GroupActiveComparator Group · 2 Interventions: Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine, Aerobic Exercise · Intervention Types: Drug, Behavioral
Medication only
Drug
ActiveComparator Group · 1 Intervention: Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2019
Completed Phase 3
~1330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completed before each medication visit, every 1 - 2 weeks up to 6 weeks.

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
397 Previous Clinical Trials
125,077 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
542 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Lily Hechtman, MD, FRCPCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
3 Previous Clinical Trials
742 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
742 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina66.7%
Ontario33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Montreal Children's Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria83.3%
Did not meet criteria16.7%
References