Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT06129396 | Unknown DMC

• 1 other identifier: 202211047RIND
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensity in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes in respect to executive functions. The main questions it aims to answer are:

• To find out the effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD
• To examine the relationship between neurophysiology and executive functions following a single bout of aerobic exercise intervention Participants will be asked to do three different executive function tasks regarding inhibitory control, working memory and cognitive planning and receive the evaluation of motor cortex excitability via transcranial magnetic stimulation (TMS) before and after a single bout of 30-min aerobic cycling exercise of moderate intensity. Researchers will compare the control group with 30-min video-watching to see if effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; A single bout of aerobic exercise; Executive functions; Neurophysiology

Outcome Measures

Primary Outcomes (7)

• Stop Signal Task (SST)

  The test will require participants to respond to an arrow stimulus pointing in a given direction. The first set incorporates 16 trials where the participants practice the response. In the second set, the participants will be told to inhibit their response if they heard an auditory signal (a beep). An adaptive staircase will be employed for the stop signal delay allowing the task to adapt to the performance of the participant to result in a 50% success rate. An inter-stimulus interval of 1,000 ms will be applied. The outcome measures are the stop signal reaction time, the estimate of when an individual can successfully inhibit their response 50% of the time. This is inferred as the time before all actions become ballistic, and the person is no longer able to stop the action

  Pre-intervention/immediately after the intervention

• Spatial Working Memory (SWM) task

  The SWM task is based on a self-ordered search test and assesses primarily nonverbal working memory. Participants are asked to search through a number of colored boxes presented on the screen to find a different token hidden inside. Each box housed only one token per trial. Searching a box more than once during a sequence resulted in within errors, and returning to an emptied box resulted in between errors. A double error could be categorized as both a within and a between error. Two major indices are presented: (1) strategy utilization: the number of search sequences starting with a novel box in both 6- and 8-box problems, and (2) errors in total and three different levels of difficulty (4-, 6-, and 8-box problems): the total errors were calculated as the sum of between errors and within errors minus double errors for searches.

  Pre-intervention/immediately after the intervention

• Stockings of Cambridge (SOC)

  The SOC requires participants to plan and execute a set of movements to replicate a goal arrangement of balls. At the beginning of each trial, there are two displays shown on the screen simultaneously, and three suspended vertical stockings and three colored balls are presented. Participants are asked to move the colored balls in a single move at a time between the stockings, to correspond to a goal position shown in the top display within a specified number of moves (2, 3, 4, and 5 moves). In the control condition, they are required to follow the ball movements as quickly as possible to provide baseline measures of reaction and movement times, with each trial being an exact replication of their earlier planning moves. Three major indices are presented: (1) number of problems solved in the specified minimum number of moves; (2) mean moves: the number of moves taken in excess of the specified minimum number, but within the maximum allowed

  Pre-intervention/immediately after the intervention

• TMS parameters: Motor evoked potential (MEP)

  TMS is applied with a figure-of-eight coil with an internal diameter of 70mm connected to a Magstim stimulator (Magstim, Whiteland, Dyfed, UK), which generates a strong, short-lasting magnetic stimulus. It induces an electric current flow in the motor cortex sufficient to activate neurons at the suprathreshold level, shown as MEP of the representational muscle. Surface MEPs is recorded from the right abductor digiti minimi muscle (ADM) with an Ag-AgCl electrode in a belly-tendon montage. The signals will be filtered (2Hz to 2 kHz, sampling rate 5 kHz), amplified, and then stored on a computer via a Power 1401 data acquisition interface (Cambridge Electronic Design, Cambridge, UK). The peak-to-peak amplitude of the MEP is defined as the overall response of the ADM induced by stimulating the contralateral motor cortex by TMS. The mean MEP is averaged in at least 15 trials and recorded as milli voltage.

  Pre-intervention/immediately after the intervention

• TMS parameters: Resting motor threshold (RMT)

  RMT is defined as the minimum TMS intensity that elicits a peak-to-peak MEP of 50\~100 microvoltage (μV) in the relaxed muscle in at least three of six consecutive trials. RMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit RMT.

  Pre-intervention/immediately after the intervention

• TMS parameters: Active motor threshold (AMT)

  AMT is the minimum intensity eliciting an MEP response of 200\~300 microvoltage (μV) during moderate spontaneous background muscle activity (\~15% of the maximum muscle strength) in at least three of six consecutive trials. AMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit AMT.

  Pre-intervention/immediately after the intervention

• TMS parameters: Short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF)

  In the SICI-ICF protocol, a subthreshold conditioning stimulus (determined as 70 % of AMT) precedes the test stimulus (determined as baseline MEP of \~1mV) with the interstimulus intervals (ISIs) of 2, 3, 5, 10, and 15ms. The first three ISIs reflect inhibitory and the last two ISIs reveal facilitatory effects. The pairs of stimuli are organized into 15 blocks. Each block contains double pulses with all ISIs, and one additional single test pulse in a pseudo-randomized order for each block. SICI is mainly influenced by GABAA receptors and ICF is thought to predominantly reflect the activity of the glutamatergic system, with some GABAA contribution. The SICI-ICF is presented as the subtraction of the conditioning stimulus by the test stimulus.

  Pre-intervention/immediately after the intervention

Study Arms (2)

Aerobic exercise group

EXPERIMENTAL

The aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with heart rate (HR) at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise.

Other: Aerobic exercise

Video-watching group

ACTIVE COMPARATOR

The video-watching group will be asked to watch a nature documentary for 30 mins

Other: Video-watching

Interventions

Aerobic exercise OTHER

The aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with HR at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise.

Aerobic exercise group

Video-watching OTHER

The video-watching group will be asked to watch a nature documentary for 30 mins

Video-watching group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of ADHD by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
• Adolescents aged between 13-17
• Absence of other neuropsychological disorders including, autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
• Right-handed

You may not qualify if:

• Presence of other major systematical diseases
• Taking neuropsychological medication within one month, except for medication for ADHD
• With contraindications for non-invasive brain stimulation such as epilepsy, pacemaker or intracranial mental implants
• Color blindness
• Taking part in other studies within one month.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Neurophysiology and Cognition in Children and Young Adults Lab, School and Graduate Institute of Physical Therapy of National Taiwan University (NTU-PT)

Taipei County, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hsiao-I Kuo, Ph.D.

  NTUPT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-I Kuo, Ph.D.

CONTACT

02-33668137; hikuo@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: September 9, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)