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Acute Effects of Exercise in College Students With ADHD

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ClinicalTrials.gov Identifier: NCT03666416
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Cynthia M Hartung, PhD, University of Wyoming

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE October 8, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • Change in Continuous Performance Test (CPT) from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    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.
  • Change in Digit Span from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    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.
  • Change in Letter-Number Sequencing from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    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.
  • Change in Spatial Span (SS) from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • Change in Continuous Performance Test (CPT) from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    The CPT is a standardized computer-administered test consisting of brief (250ms) 360 letter presentations on a computer screen. Participants are tasked with pressing the spacebar when any letter, except "X," appears. 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.
  • Change in Reading Span (Rspan) from appointment 1 to 2 [ Time Frame: Completed at each experimental appointment over a period of two weeks ]
    A reading span task (Rspan; Unsworth et al., 2005) will be used to measure the executive function domain of working memory. This computer-administered task requires participants to read and analyze sentences while remembering a set of unrelated letters. Participants will complete the Rpan working memory task at each experimental appointment. For the SIT appointment, participants will complete the Rspan 15 minutes after exercise termination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • Depression, Anxiety, and Stress Scale-Modified (DASS-M) [ Time Frame: Completed the day after each experimental appointment over a period of two weeks ]
    This scale includes 21 questions to measure current mood and stress levels. Items include a choice of four responses from "Did not apply to me at all," to "Applied to me very much." Participants will receive the survey via text and email the morning after their experimental appointment. They will be instructed to complete the DASS-M regarding their emotional experiences of depression, anxiety, and stress from "yesterday (from the time after your lab appointment until you went to bed)."
  • Barkley Adult ADHD Rating Scale-Modified (BAARS-M) [ Time Frame: Completed the day after each experimental appointment over a period of two weeks ]
    The BAARS includes 18 items that closely follow the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; APA, 2013) criteria for ADHD. Participants will be asked to rate their current behavior over the past 6 months from 0 (Never/Rarely) to 3 (Very Often).Participants will receive the survey via text and email the morning after their experimental appointment. They will be instructed to complete the BAARS-M regarding their ADHD-related behavior from "the previous day."
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of Exercise in College Students With ADHD
Official Title  ICMJE Acute Effects of Exercise in College Students With ADHD
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).

Detailed Description

Participant enrollment will consist of forty-eight University of Wyoming (UW) and Laramie County Community College (LCCC) students (24 ADHD group, 24 comparison group) with an even distribution of men and women in each group. Power analyses (G*Power 3.1) indicated a sample of at least this size is needed to provide 80% power to detect medium effects which have been observed in samples of children with ADHD. Students taking medications that may confound cognitive performance (e.g., antipsychotics, sedatives), are outside the age range (18-25 years), or are at an elevated risk for physical exercise contraindications will be excluded. Prospective ADHD group participants will be recruited through four means. First, students who complete a separate study and endorse five or more inattention (IA) symptoms or report being previously diagnosed with ADHD will be invited for an eligibility assessment. Second, recruitment flyers will be posted on campus. Third, participants will be contacted from previous studies who were diagnosed with ADHD and consented to contact for future research. Fourth, university medical and mental health staff will advertise the study to student clients who have ADHD. Comparison group subjects will be composed of students who complete a separate study, who disavow being diagnosed with ADHD, and endorse three or fewer IA symptoms. As students enroll in the ADHD group, age- and sex-matched comparison subjects will be enrolled. Prior to study enrollment, prospective participants must stratify as being at low risk for physical exercise contraindications using a health history screening questionnaire. Prospective ADHD participants must also meet diagnostic criteria for ADHD on a structured clinical interview.

All prospective participants will attend an in-lab appointment to confirm their eligibility, including (a) stratifying as being at low risk for physical exercise contraindications and (b) ADHD prospects meeting diagnostic threshold. After enrolling in the study, participants will be scheduled for two in-lab experimental appointments: sprint interval training (SIT) and Non-SIT. The ordering of experimental appointments will be counterbalanced. This will be done to evaluate possible appointment ordering effects and minimize confounding effects. Both appointments will be scheduled in the mornings, on the same day of the week and at the same time of day. Participants will be asked to wear athletic clothing, as well as abstain from exercise, alcohol, caffeine, and stimulant medication for 12 hours prior to their experimental appointments to minimize the influence they may have on our independent (exercise) and dependent variables (executive functioning). Participants will complete the execute functioning tasks (i.e., Continuous Performance Task or CPT, Digit Span, Letter-Number Sequencing, and Spatial Span or SS) during both the Non-SIT and SIT appointments. They will also be sent a modified mood (i.e., Depression, Anxiety, and Stress Scale or DASS) and ADHD symptoms (Barkley Adult ADHD Rating Scale or BAARS) questionnaire the morning following all experimental appointments. High-intensity SIT was chosen for the proposed study because moderate- to high-intensity aerobic exercises appears to lead to the greatest improvements in cognitive performance among youth with ADHD. The researcher will lead the participant through a set of stretches and 3 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. After each interval, participants will be asked to provide their perceived exertion during the interval, and the researcher will record participant's peak interval heart rate (HR). These measurements are taken to validate that participants exercised at a high intensity. The experimenter will provide encouragement to the participant to work towards ≥85% of their maximum HR. After the eighth and last interval, the participant will rest for 15 minutes before completing the cognitive tasks (i.e., CPT, Digit Span, Letter-Number Sequencing, and SS).

Prior to analyses, all variables will be screened. Violations of statistical assumptions will be addressed through data transformations or nonparametric statistics. Relative improvements on objective measurements of EF (i.e., CPT, Digit Span, Letter-Number Sequencing, and SS performance indices) will be examined through 2 (ADHD vs. comparison) x 2 (men vs. women) x 2 (Non-SIT vs. SIT) repeated measures ANOVAs. When interaction effects are significant, paired samples t-tests will be used to evaluate group differences. When interaction effects fail to reach statistical significance, independent samples t-tests will be used to evaluate group differences. The magnitude of omnibus effects for repeated measures ANOVAs will be calculated using partial eta-squared (ηp2). Within-group effects (Cohen's d) and corresponding confidence intervals for within-group effect sizes will be standardized using the variability of non-SIT scores. Between-group effects will be calculated using Hedges g. Values for ηp2 of .01, .06, and .14 will be considered small, medium, and large effects, respectively; corresponding values for d and g are .20, .50, and .80.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a within-subjects design where participants complete outcome measures with and without exercise intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder
  • Effects of; Exertion
  • Working Memory
  • Change in Sustained Attention
Intervention  ICMJE Behavioral: Sprint Interval Training
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.
Study Arms  ICMJE Experimental: Sprint Interval Training
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.
Intervention: Behavioral: Sprint Interval Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 25 years.
  • University of Wyoming (UW) or Laramie County Community College (LCCC) student.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cynthia M Hartung, Ph.D. 307-314-2123 chartung@uwyo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03666416
Other Study ID Numbers  ICMJE 20170220PL01463
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cynthia M Hartung, PhD, University of Wyoming
Study Sponsor  ICMJE University of Wyoming
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cynthia M Hartung, Ph.D. University of Wyoming
PRS Account University of Wyoming
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP