Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Acute Effects of Exercise in College Students With ADHD
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).
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 29 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 29 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wyoming | Laramie | Wyoming |
Lead Sponsor | Collaborator |
---|---|
University of Wyoming |
United States,
Borg, G. A. (1998). Borg's perceived exertion and pain scales. Champaign, IL: Human Kinetics.
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. — View Citation
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. — View Citation
Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum.
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. — View Citation
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
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
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.
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Depression, Anxiety, and Stress Scale-Modified (DASS-M) | 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)." | Completed the day after each experimental appointment over a period of two weeks | |
Secondary | Barkley Adult ADHD Rating Scale-Modified (BAARS-M) | 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." | Completed the day after each experimental appointment over a period of two weeks |
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