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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

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).


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Effects of; Exertion Working Memory Change in Sustained Attention Behavioral: Sprint Interval Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Official Title: Acute Effects of Exercise in College Students With ADHD
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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)."

  2. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03666416


Contacts
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Contact: Cynthia M Hartung, Ph.D. 307-314-2123 chartung@uwyo.edu

Locations
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United States, Wyoming
University of Wyoming Recruiting
Laramie, Wyoming, United States, 82071
Contact: Cynthia M Hartung, Ph.D.    307-314-2123    chartung@uwyo.edu   
Sponsors and Collaborators
University of Wyoming
Investigators
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Principal Investigator: Cynthia M Hartung, Ph.D. University of Wyoming
Publications:
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
Borg, G. A. (1998). Borg's perceived exertion and pain scales. Champaign, IL: Human Kinetics.
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.
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
Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum.

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Responsible Party: Cynthia M Hartung, PhD, Associate Professor, University of Wyoming
ClinicalTrials.gov Identifier: NCT03666416    
Other Study ID Numbers: 20170220PL01463
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders