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The Effectiveness of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT02788851
Recruitment Status : Active, not recruiting
First Posted : June 2, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Lily Hechtman, McGill University Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Drug: Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine Behavioral: Aerobic Exercise Not Applicable

Detailed Description:

Background: Several interventional studies have shown improvement in core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with aerobic exercise as an add-on therapy for children with ADHD treated with stimulants. Studies in the general population have shown that aerobic exercise in adults may improve cognitive function in general and executive function in particular. Although non-medication treatment for ADHD has focused on cognitive training in addition to medication, some evidence indicate that intense aerobic exercise impacts brain structure, improves brain function, and has effects similar to stimulant medication.

Objectives: To assess the effectiveness, regarding ADHD symptoms, of an eight week aerobic exercise intervention, medication, and the combination of both aerobic exercise and medication treatments for adults with ADHD. The secondary objectives are to determine the effectiveness of these treatments on social skills, as measured by functioning in work, social, and family situations; anxiety symptoms; depressive symptoms; self-esteem; and the effect of motivation for exercise on adherence to exercise treatment.

Hypothesis: Investigators hypothesize that the combined group which receives aerobic exercise and medication intervention will have the greatest improvement in both primary and secondary outcome measures; that treatment gains will be maintained at follow-up only if treatments are continued.

Methods: Participants will be randomly assigned to one of three groups:

  1. Aerobic exercise intervention only. Participants of this group will meet twice a week for 8 consecutive weeks. Each meeting will involve 1 hour of moderate-vigorous intensity aerobic exercise.
  2. Medication treatment only. Participants of this group will receive optimal medication for them and will gradually be titrated up to their optimal dose. Once they are optimally titrated, they will attend 8 weekly sessions of an education class, which will focus on different topics of adult ADHD. These meetings will last 1 hour each week. Educational meetings are meant to control for group effects of the exercise group intervention.
  3. Medication combined with aerobic-exercise intervention. Participants of this group will receive optimal medication for them and will gradually be titrated up to their optimal dose. When the participants of this group will be at their optimal medication dose, they will begin the aerobic exercise classes twice a week for 8 weeks. They will not receive the educational sessions.

Randomization will be stratified by sex, age and the degree of physical activity per week. Power analyses indicate that 23 participants are needed per each treatment arm, accounting for a dropout rate of 20%. Therefore initial enrollments should be at minimum 69 patients for all three arms, at least 23 patients per arm. There will 2 groups in each arm of the study, accounting for 10-15 participants per group at any one time.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Relative Efficacy of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD) Versus Medication Only and the Combination of the Two: A Pilot Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Medication only
Stimulant or non-stimulant medication only - Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine. Investigators will be using a product approved for clinical use in Canada), with dose optimized for each participant based on report of efficacy and side effects. Once on an optimal dose of stimulant or non-stimulant medication they will attend 8 weekly education sessions about ADHD.
Drug: Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine
Medication is titrated over a 4-week period with stepwise increments each week. Participants and their significant others will complete ADHD symptom scales at baseline and before each medication visit. Participants also complete a side effects scale at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the participant will remain on this dose for the remainder of the study. Additionally, once the optimal dose is reached participants will attend 8 weekly educational sessions about ADHD in adulthood.
Other Names:
  • Ritalin
  • Concerta
  • Biphentin
  • Dexedrine
  • Adderall XR
  • Vyvanse
  • Strattera
  • Guanfacine
  • Intuniv

Experimental: Aerobic Exercise only
Participants attend a structured aerobic exercise class, twice a week for 8 weeks.
Behavioral: Aerobic Exercise
Participants will attend a structured aerobic exercise class twice a week for 8 weeks. Each class will last 60 minutes.

Active Comparator: Combination Group
Participants assigned to this group will be optimally medicated (either stimulant or non-stimulant medication - approved for clinical use in Canada) and will attend a structured aerobic exercise class, twice a week for 8 weeks.
Drug: Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine
Medication is titrated over a 4-week period with stepwise increments each week. Participants and their significant others will complete ADHD symptom scales at baseline and before each medication visit. Participants also complete a side effects scale at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the participant will remain on this dose for the remainder of the study. Additionally, once the optimal dose is reached participants will attend 8 weekly educational sessions about ADHD in adulthood.
Other Names:
  • Ritalin
  • Concerta
  • Biphentin
  • Dexedrine
  • Adderall XR
  • Vyvanse
  • Strattera
  • Guanfacine
  • Intuniv

Behavioral: Aerobic Exercise
Participants will attend a structured aerobic exercise class twice a week for 8 weeks. Each class will last 60 minutes.




Primary Outcome Measures :
  1. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]

Secondary Outcome Measures :
  1. Depression symptoms (via the Beck Depression Inventory) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  2. Anxiety Symptoms (measured via the Beck Anxiety Inventory) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  3. Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  4. Self-esteem (measured via the Index of Self-Esteem) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  5. Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  6. Motivation to exercise (measured via the Physical Activity and Leisure Motivation Scale) - Change from baseline [ Time Frame: At baseline; once optimally titrated (about 5 weeks to reach this dose for medication groups); after 8 weeks of intervention (aerobic exercise or educational sessions); 3 months after the end of intervention; 6 months after the end of intervention ]
  7. Stimulant medication side effects (measured via the Canadian ADHD Resource Alliance (CADDRA) Patient ADHD Medication Form) [ Time Frame: Completed before each medication visit, every 1 - 2 weeks up to 6 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for adult ADHD of any of three presentations (inattentive, hyperactive impulsive, combined) via Conners Adult ADHD Diagnostic Interview for the DSM-5 (CAARD-D) and clinician's assessment;
  2. Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants (parents or siblings for childhood symptoms, spouses or co-workers for current symptoms). Required cut off on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
  3. Conners Adult ADHD Rating Scale (1999) completed by self and informants, such as spouses or co-workers for current ADHD symptoms. Required cut off on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
  4. Between 18 and 60 years old
  5. Be able to give informed consent and comply with study procedures;
  6. I.Q. of 85 or above on Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) by three verbal and three nonverbal subtests
  7. Adequate command of English to be able to participate in the group treatment.
  8. Written permission from a family physician to participate in aerobic exercise and no contra-indications for stimulant medication.

Exclusion Criteria:

  1. Psychotic symptoms, past or current;
  2. Current psychiatric comorbidity, which needs ongoing medication treatment e.g. bipolar disorder, major depression, suicidality, anxiety, current substance use disorder (must be free of substance abuse for 12 months);
  3. Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette syndrome, etc.
  4. Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis.
  5. Pregnant or breastfeeding women.
  6. Patients currently involved in intensive aerobic exercise, two hours per week or more.
  7. Patients who are currently effectively treated for ADHD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788851


Locations
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Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Center
Investigators
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Principal Investigator: Lily Hechtman, MD, FRCPC McGill University Health Center

Publications:

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Responsible Party: Lily Hechtman, Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02788851     History of Changes
Other Study ID Numbers: MUHC-15-226
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lily Hechtman, McGill University Health Center:
Stimulant Medication
Exercise
Functional Outcome
Effectiveness
Symptoms

Additional relevant MeSH terms:
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Amphetamine
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine Hydrochloride
Guanfacine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists