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

NCT02788851 | Unknown

• 1 other identifier: MUHC-15-226
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Stimulant Medication; Exercise; Functional Outcome; Effectiveness; Symptoms

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (7)

• Depression symptoms (via the Beck Depression Inventory) - Change from baseline

  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

• Anxiety Symptoms (measured via the Beck Anxiety Inventory) - Change from baseline

  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

• Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline

  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

• Self-esteem (measured via the Index of Self-Esteem) - Change from baseline

  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

• Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline

  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

Study Arms (3)

Medication only

ACTIVE COMPARATOR

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

Aerobic Exercise only

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Combination Group

ACTIVE COMPARATOR

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; Behavioral: Aerobic Exercise

Interventions

Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine DRUG

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.

Also known as: Ritalin, Concerta, Biphentin, Dexedrine, Adderall XR, Vyvanse, Strattera, Guanfacine, Intuniv

Combination Group; Medication only

Aerobic Exercise BEHAVIORAL

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

Aerobic Exercise only; Combination Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (15)

• Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.

  PMID: 21299297 BACKGROUND

• Kang KD, Choi JW, Kang SG, Han DH. Sports therapy for attention, cognitions and sociality. Int J Sports Med. 2011 Dec;32(12):953-9. doi: 10.1055/s-0031-1283175. Epub 2011 Nov 8.

  PMID: 22068930 BACKGROUND

• Smith AL, Hoza B, Linnea K, McQuade JD, Tomb M, Vaughn AJ, Shoulberg EK, Hook H. Pilot physical activity intervention reduces severity of ADHD symptoms in young children. J Atten Disord. 2013 Jan;17(1):70-82. doi: 10.1177/1087054711417395. Epub 2011 Aug 25.

  PMID: 21868587 BACKGROUND

• Tantillo M, Kesick CM, Hynd GW, Dishman RK. The effects of exercise on children with attention-deficit hyperactivity disorder. Med Sci Sports Exerc. 2002 Feb;34(2):203-12. doi: 10.1097/00005768-200202000-00004.

  PMID: 11828226 BACKGROUND

• Kramer AF, Hahn S, Cohen NJ, Banich MT, McAuley E, Harrison CR, Chason J, Vakil E, Bardell L, Boileau RA, Colcombe A. Ageing, fitness and neurocognitive function. Nature. 1999 Jul 29;400(6743):418-9. doi: 10.1038/22682. No abstract available.

  PMID: 10440369 BACKGROUND

• Fiatarone Singh MA, Gates N, Saigal N, Wilson GC, Meiklejohn J, Brodaty H, Wen W, Singh N, Baune BT, Suo C, Baker MK, Foroughi N, Wang Y, Sachdev PS, Valenzuela M. The Study of Mental and Resistance Training (SMART) study-resistance training and/or cognitive training in mild cognitive impairment: a randomized, double-blind, double-sham controlled trial. J Am Med Dir Assoc. 2014 Dec;15(12):873-80. doi: 10.1016/j.jamda.2014.09.010. Epub 2014 Oct 23.

  PMID: 25444575 BACKGROUND

• Verret C, Guay MC, Berthiaume C, Gardiner P, Beliveau L. A physical activity program improves behavior and cognitive functions in children with ADHD: an exploratory study. J Atten Disord. 2012 Jan;16(1):71-80. doi: 10.1177/1087054710379735. Epub 2010 Sep 13.

  PMID: 20837978 BACKGROUND

• Robinson AM, Bucci DJ. Individual and combined effects of physical exercise and methylphenidate on orienting behavior and social interaction in spontaneously hypertensive rats. Behav Neurosci. 2014 Dec;128(6):703-12. doi: 10.1037/bne0000015. Epub 2014 Aug 25.

  PMID: 25150541 BACKGROUND

• Freeman MP. ADHD and pregnancy. Am J Psychiatry. 2014 Jul;171(7):723-8. doi: 10.1176/appi.ajp.2013.13050680.

  PMID: 24980168 BACKGROUND

• Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.

  PMID: 10536127 BACKGROUND

• Nishime EO, Cole CR, Blackstone EH, Pashkow FJ, Lauer MS. Heart rate recovery and treadmill exercise score as predictors of mortality in patients referred for exercise ECG. JAMA. 2000 Sep 20;284(11):1392-8. doi: 10.1001/jama.284.11.1392.

  PMID: 10989401 BACKGROUND

• Gajria K, Lu M, Sikirica V, Greven P, Zhong Y, Qin P, Xie J. Adherence, persistence, and medication discontinuation in patients with attention-deficit/hyperactivity disorder - a systematic literature review. Neuropsychiatr Dis Treat. 2014 Aug 22;10:1543-69. doi: 10.2147/NDT.S65721. eCollection 2014.

  PMID: 25187718 BACKGROUND

• Joseph A, Cloutier M, Guerin A, Nitulescu R, Sikirica V. Treatment outcomes after methylphenidate in adults with attention-deficit/hyperactivity disorder treated with lisdexamfetamine dimesylate or atomoxetine. Patient Prefer Adherence. 2016 Mar 24;10:391-405. doi: 10.2147/PPA.S98498. eCollection 2016.

  PMID: 27069357 BACKGROUND

• Barnes DE, Santos-Modesitt W, Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189.

  PMID: 23545598 BACKGROUND

• Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.

  PMID: 20736471 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Motor Activity

Interventions

Guanfacine; Methylphenidate; Dextroamphetamine; SLI381; Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride; Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Propylamines; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lily Hechtman, MD, FRCPC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 2, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)