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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine
Aerobic Exercise
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Stimulant Medication, Exercise, Functional Outcome, Effectiveness, Symptoms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Medication only

Aerobic Exercise only

Combination Group

Arm Description

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.

Participants attend a structured aerobic exercise class, twice a week for 8 weeks.

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.

Outcomes

Primary Outcome Measures

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2016
Last Updated
August 13, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02788851
Brief Title
The Effectiveness of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
Stimulant Medication, Exercise, Functional Outcome, Effectiveness, Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medication only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic Exercise only
Arm Type
Experimental
Arm Description
Participants attend a structured aerobic exercise class, twice a week for 8 weeks.
Arm Title
Combination Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine
Other Intervention Name(s)
Ritalin, Concerta, Biphentin, Dexedrine, Adderall XR, Vyvanse, Strattera, Guanfacine, Intuniv
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Participants will attend a structured aerobic exercise class twice a week for 8 weeks. Each class will last 60 minutes.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; 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; 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; Between 18 and 60 years old Be able to give informed consent and comply with study procedures; I.Q. of 85 or above on Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) by three verbal and three nonverbal subtests Adequate command of English to be able to participate in the group treatment. Written permission from a family physician to participate in aerobic exercise and no contra-indications for stimulant medication. Exclusion Criteria: Psychotic symptoms, past or current; 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); Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette syndrome, etc. Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis. Pregnant or breastfeeding women. Patients currently involved in intensive aerobic exercise, two hours per week or more. Patients who are currently effectively treated for ADHD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lily Hechtman, MD, FRCPC
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effectiveness of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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