Attention Deficit Hyperactivity DisorderNCT03666416
Acute Effects of Exercise in College Students With ADHD
A study testing Sprint Interval Training in people with Attention Deficit Hyperactivity Disorder and Effects of; Exertion, run by University of Wyoming at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Effects of; Exertion, Working Memory
- What is being tested?
- Sprint Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 29 years.
- University of Wyoming (UW) or Laramie County Community College (LCCC) student.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Wyoming
Laramie, Wyoming, 82071
Cynthia M Hartung, Ph.D., 307-314-2123, chartung@uwyo.edu
About this study
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).
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Effects of; Exertion, Working Memory, Change in Sustained Attention
- Being tested
- Sprint Interval Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint Interval TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sprint Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Completed at each experimental appointment over a period of two weeks
Secondary outcomes (2)
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)."
Measured: Completed the day after each experimental appointment over a period of two weeks
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."
Measured: Completed the day after each experimental appointment over a period of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start8 Oct 2018
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a within-subjects design where participants complete outcome measures with and without exercise intervention.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia M Hartung, PhD, University of Wyoming
- Investigators
- Cynthia M Hartung, Ph.D., Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666416
- Sponsor's protocol ID
- 20170220PL01463
- Status last verified
- Jun 2024
- First submitted
- 31 Aug 2018
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25201345Chang 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.
PubMed 22306962Choi 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.
PubMed 24824770Neudecker 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.
PubMed 25964449Gapin, 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
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.
PubMed 17695343Borg, 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Exercise in College Students With ADHD
- ClinicalTrials.gov ID
- NCT03666416
- Acronym / sponsor ID
- 20170220PL01463
- Conditions
- Attention Deficit Hyperactivity Disorder, Effects of; Exertion, Working Memory, Change in Sustained Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a within-subjects design where participants complete outcome measures with and without exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Sprint Interval Training | Experimental | Behavioral: Sprint Interval TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 29 years.
- University of Wyoming (UW) or Laramie County Community College (LCCC) student.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprint Interval TrainingParticipants 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. | Behavioural | Sprint Interval Training |
Primary outcome
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.
2 secondary outcomes
Depression, Anxiety, and Stress Scale-Modified (DASS-M)
Time frame: Completed the day after each experimental appointment over a period of two weeks
Barkley Adult ADHD Rating Scale-Modified (BAARS-M)
Time frame: Completed the day after each experimental appointment over a period of two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 25201345Hoza 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.
- Background: PubMed 22306962Chang 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.
- Background: PubMed 24824770Choi 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.
- Background: PubMed 25964449Neudecker 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.
- BackgroundGapin, 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: PubMed 17695343Faul 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.
- BackgroundBorg, G. A. (1998). Borg's perceived exertion and pain scales. Champaign, IL: Human Kinetics.
- BackgroundHowell, 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.
- BackgroundHedges, 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
- BackgroundCohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia M Hartung, Ph.D. principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sprint Interval Training in people with Attention Deficit Hyperactivity Disorder and Effects of; Exertion, run by University of Wyoming at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia M Hartung, Ph.D. (307-314-2123, chartung@uwyo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666416, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.