NCT03666416

Brief Summary

The overall objective of this study is to examine physical exercise as an intervention for ADHD. The rationale for the proposed study is that physical exercise could serve as an effective treatment for college students with ADHD that has low costs, low risks, and ancillary health benefits and may address the limitations of existing treatments. The central hypothesis is that college students with ADHD will exhibit greater degrees of improvement in executive functioning (i.e., sustained attention, working memory) immediately following sprint interval training (SIT), relative to non-ADHD peers. This hypothesis was formulated based on preliminary studies demonstrating reduced ADHD symptoms and improved executive functioning following physical exercise. Multiple 2 (ADHD vs. control) x 2 (male vs. female) x 2 (exercise vs. none) repeated measures ANOVAs will be conducted to compare students with ADHD (n = 24) to controls (n = 24). The expected outcomes are to confirm this hypothesis and demonstrate the need for further study of physical exercise. If confirmed, the results will provide pilot data for a larger NIH grant proposal aimed at further examining the acute effects of physical exercise (i.e., improved cognitive functioning immediately following exercise) and also the chronic effects of physical exercise (i.e., improved functioning after engaging in regular exercise for an extended period). This outcome is expected to have an important positive impact because physical exercise may serve as an effective treatment for college students with ADHD that is less risky than stimulants, less time-consuming than therapy, and provides ancillary health benefits (i.e., increasing physical fitness, decreasing obesity).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

6.7 years

First QC Date

August 31, 2018

Last Update Submit

June 7, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Continuous Performance Test (CPT) from appointment 1 to 2

    The CPT is a standardized computer-administered test consisting of four-digit numbers that are presented for 200ms on a white screen with 1500ms between the presentation of each number. Participants must press the spacebar as quickly as possible when the preceding four-digit number matches the current four-digit number Participants will complete the CPT as a measure of sustained attention at each experimental appointment. For the SIT appointment, participants will complete the CPT 15 minutes after exercise termination.

    Completed at each experimental appointment over a period of two weeks

  • Change in Digit Span from appointment 1 to 2

    The Digit Span (Wechsler, 2008) subtest of the Wechsler Adult Intelligence Scale (WAIS-IV) is an auditory working memory task. The researcher will say numbers aloud at a rate of one number per second. The participant will be tasked with remembering and repeating the numbers in a prescribed (forward, backward, sequencing) order. Participants will complete the Digit Span (forward, backward and sequencing) auditory working memory task at each experimental appointment. For the SIT appointment, participants will complete the Digit Span (forward, backward and sequencing) tasks approximately 15 minutes after exercise termination.

    Completed at each experimental appointment over a period of two weeks

  • Change in Letter-Number Sequencing from appointment 1 to 2

    The Letter-Number Sequencing (Wechsler, 2008) task is a supplemental subtest of the Wechsler Adult Intelligence Scale (WAIS-IV) that measures auditory working memory. Researchers will read a sequence of letters and numbers, and the participant will attempt to recall the numbers in ascending order and the letters in alphabetical order. Participants will complete the Letter-Number Sequencing auditory working memory task at each experimental appointment. For the SIT appointment, participants will complete the Letter-Number Sequencing task approximately 15 minutes after exercise termination.

    Completed at each experimental appointment over a period of two weeks

  • Change in Spatial Span (SS) from appointment 1 to 2

    The Spatial Span (SS) is a computer-administered task assessing visuospatial working memory. Participants will be tasked with remembering the order of stimuli that are presented in forward and backward sequences. Participants will complete the SS visuospatial working memory task at each experimental appointment. For the SIT appointment, participants will complete the SS task approximately 15 minutes after exercise termination.

    Completed at each experimental appointment over a period of two weeks

Secondary Outcomes (2)

  • Depression, Anxiety, and Stress Scale-Modified (DASS-M)

    Completed the day after each experimental appointment over a period of two weeks

  • Barkley Adult ADHD Rating Scale-Modified (BAARS-M)

    Completed the day after each experimental appointment over a period of two weeks

Study Arms (1)

Sprint Interval Training

EXPERIMENTAL

Participants will be scheduled for two in-lab experimental appointments: sprint interval training (SIT) and Non-SIT. During the SIT appointment, the researcher will lead the participant through a set of stretches and three minutes of low-intensity cycling on a Schwinn AD2 Airdyne leg-cycling and arm-cranking ergometer to warm up and increase blood flow to active muscles. Participants will then complete 16 minutes of SIT, consisting of eight bouts of 20 seconds of cycling followed by 100 seconds of rest. Participants will complete computer-based tests of sustained attention and working memory during both the SIT (15 minutes following the exercise) and Non-SIT appointments.

Behavioral: Sprint Interval Training

Interventions

Participants will attend two experimental appointments, during which they will complete two identical executive functioning tasks (i.e., sustained attention, working memory). During one appointment, participants will receive the sprint interval training manipulation prior to completing the tasks.

Sprint Interval Training

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 29 years.
  • University of Wyoming (UW) or Laramie County Community College (LCCC) student.

You may not qualify if:

  • Predominantly hyperactive/impulsive presentations of ADHD (ADHD-HI), as this presentation is unusual in adulthood.
  • Use of medications that negatively affect cognitive performance (e.g., sedatives, antipsychotics).
  • Pregnancy or trying to become pregnant.
  • Non-ambulatory or relying on walking aids for ambulation.
  • History of a stroke or an aneurysm.
  • High risk for physical exercise contraindications due to genetic/medical conditions (e.g., cardiovascular or pulmonary disease).
  • Exercise or physical activity restrictions imposed by a health provider.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

RECRUITING

Related Publications (10)

  • Hoza B, Smith AL, Shoulberg EK, Linnea KS, Dorsch TE, Blazo JA, Alerding CM, McCabe GP. A randomized trial examining the effects of aerobic physical activity on attention-deficit/hyperactivity disorder symptoms in young children. J Abnorm Child Psychol. 2015 May;43(4):655-67. doi: 10.1007/s10802-014-9929-y.

    PMID: 25201345BACKGROUND
  • Chang YK, Liu S, Yu HH, Lee YH. Effect of acute exercise on executive function in children with attention deficit hyperactivity disorder. Arch Clin Neuropsychol. 2012 Mar;27(2):225-37. doi: 10.1093/arclin/acr094. Epub 2012 Feb 3.

    PMID: 22306962BACKGROUND
  • Choi JW, Han DH, Kang KD, Jung HY, Renshaw PF. Aerobic exercise and attention deficit hyperactivity disorder: brain research. Med Sci Sports Exerc. 2015 Jan;47(1):33-9. doi: 10.1249/MSS.0000000000000373.

    PMID: 24824770BACKGROUND
  • Neudecker C, Mewes N, Reimers AK, Woll A. Exercise Interventions in Children and Adolescents With ADHD: A Systematic Review. J Atten Disord. 2019 Feb;23(4):307-324. doi: 10.1177/1087054715584053. Epub 2015 May 11.

    PMID: 25964449BACKGROUND
  • Gapin, J. I., Labban, J. D., Bohall, S. C., Wooten, J. S., & Chang, Y. (2015). Acute exercise is associated with specific executive functions in college students with ADHD: A preliminary study. Journal of Sport and Health Science, 4, 89-96. doi:10.1016/j.jshs.2014.11.003

    BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • Borg, G. A. (1998). Borg's perceived exertion and pain scales. Champaign, IL: Human Kinetics.

    BACKGROUND
  • Howell, D. C. (2011). Confidence intervals on effect size. http://www.uvm.edu/~dhowell/methods8/Supplements/Confidence%20Intervals%20on%20Effect%20Size.pdf. Accessed August 23, 2013.

    BACKGROUND
  • Hedges, L. V. (1982). Fitting categorical models to effect sizes from a series of experiments. Journal of Educational Statistics, 7, 119-37. doi: 10.2307/1164961

    BACKGROUND
  • Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum.

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cynthia M Hartung, Ph.D.

    University of Wyoming

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia M Hartung, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a within-subjects design where participants complete outcome measures with and without exercise intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 11, 2018

Study Start

October 8, 2018

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations