Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001030561
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
27/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise in Adults with Attention Deficit Hyperactivity Disorder (ADHD).
Scientific title
Effect of Exercise and Physical Activity on Sustained Attention in Adults with Attention Deficit/Hyperactivity Disorder (ADHD).
Secondary ID [1] 311905 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Ex-ADHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit/Hyperactivity Disorder (ADHD). 333489 0
Condition category
Condition code
Mental Health 330167 330167 0 0
Other mental health disorders
Neurological 330519 330519 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will be conducted in the Susan Wakil Health Building at the University of Sydney.

First, participants will undergo baseline testing involving two four hour testing sessions across two days, one week apart, during which their one-repetition maximum (1RM) will be assessed for six resistance exercises on Keiser machines (leg press, knee extension, knee flexion, chest press, seated row, triceps pushdown). 1RM assessments will be done one-on-one with an Accredited Exercise Physiologist.

On a separate day, participants will complete a single bout of High Intensity (80% 1RM) Resistance Exercise (Leg Press, Knee Extension, Knee Flexion, Chest Press, Seated Row, triceps pushdown) one-on-one supervised by an Accredited Exercise Physiologist to ensure safety and adherence. Participants will perform three sets of eight repetitions at a load equivalent to 80% of their pre-determined 1RM. There will be one minute of rest between each set. The tempo of the exercise will be 1s concentric, 1s pause, 2s eccentric, 1s pause. Total session duration will be approximately 45 minutes. Adherence will be recorded through supervision by research staff and logging of each completed exercise.

All sessions will be conducted in the morning (before 12PM). Participants will be require to withhold any medication used to treat ADHD for a minimum of 12 hours.

Participants will complete sessions (intervention or control) one week apart to ensure an appropriate wash out period.
Intervention code [1] 328375 0
Lifestyle
Comparator / control treatment
The session will include both stretching and balance training, conducted one-on-one by an Accredited Exercise Physiologist to ensure safety and adherence.

The Stretching includes - 2x30 seconds per stretch for hamstrings (unilateral), quadriceps (unilateral), hip flexors (Unilateral), gluteus maximus (unilateral), lats (unilateral), pec major (Unilateral).

The Balance Training includes – a narrow stance on foam, a slow tandem walk, bouncing ball against a wall and catching with their dominant hand.

Consistent with the intervention condition, the total session duration will be approximately 45 minutes in total, consisting of 10 minutes of stretching and 35 minutes of balance training. Adherence will be recorded through supervision by research staff and logging of each completed exercise.

All sessions will be conducted in the morning (before 12PM). Participants will be required to withhold any medication used to treat ADHD for a minimum of 12 hours.

Participants will complete sessions (intervention or control) one week apart to ensure an appropriate washout period.
Control group
Active

Outcomes
Primary outcome [1] 337927 0
Sustained Attention
Timepoint [1] 337927 0
Baseline, immediately following control and intervention conditions.
Secondary outcome [1] 433746 0
Impulsivity
Timepoint [1] 433746 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [2] 433747 0
Vigilance
Timepoint [2] 433747 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [3] 433748 0
Inattention
Timepoint [3] 433748 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [4] 433749 0
Inhibitory Control - Response Inhibition
Timepoint [4] 433749 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [5] 433750 0
Sustained Attention
Timepoint [5] 433750 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [6] 433751 0
Processing Speed
Timepoint [6] 433751 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [7] 433752 0
Response Variability
Timepoint [7] 433752 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [8] 433753 0
Response Inhibition - Interference Control
Timepoint [8] 433753 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [9] 433754 0
Inhibitory Control
Timepoint [9] 433754 0
Baseline, immediately following the intervention and control conditions.
Secondary outcome [10] 433755 0
Affect
Timepoint [10] 433755 0
Baseline, immediately before the intervention and control conditions as well as following cognitive testing after each condition.
Secondary outcome [11] 435319 0
Mood - Depression
Timepoint [11] 435319 0
Baseline, immediately before the intervention and control condition as well as following cognitive testing after each condition.

Eligibility
Key inclusion criteria
• ASRS 5 score of 14 or higher
• Not meeting physical activity guidelines (less than 150min/week of moderate-intensity physical activity, or equivalent).
• Not currently participating in any resistance exercise (last 12 months).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not diagnosed with ADHD by an appropriately trained health professional.
• Active psychosis, substance use disorder (past 12 months).
• Current suicidal ideation or attempt to end their own life in the past 12 months.
• medical conditions that would preclude the required activity.
• musculoskeletal injuries, clinical conditions or limitations that would preclude the required activity
• cardiac, peripheral vascular, or cerebrovascular disease that would preclude the required activity
• Amputation of upper or lower limb.
• Intellectual Disability.
• Autism Spectrum Disorder.
• Down Syndrome or other congenital intellectual impairments.
• Traumatic Brain Injury.
• Currently pregnant or suspects they are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by embedding the sequence within Research Electronic Data Capture (REDCap). Randomisation will occur following the completion of all baseline assessment by the investigator pushing the randomise button.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by someone not involved in the study, who will then embed the sequence within RedCAP. Using the randomizeBE package in R, a randomised, counterbalanced sequence will be generated with randomly permuting blocks of two, four, six, eight. Randomisation will be stratified according to age, sex and current ADHD treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcomes will be analysed using linear mixed effects models with repeated measures. First, and unadjusted model will be run with main effects of CONDITION (2 levels; RE or Stretching), TIME (2 levels; Pre and Post) and their interaction CONDITIONxTIME will be entered. Next, adjusted models will be run with covariates selected a priori (age, sex and medication use for ADHD) as well as additional confounders associated with the dependent variable of interest. Significance will be set at a=0.05 for all outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316254 0
University
Name [1] 316254 0
Faculty of Medicine and Health, The University of Sydney
Country [1] 316254 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318443 0
None
Name [1] 318443 0
Address [1] 318443 0
Country [1] 318443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315074 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315074 0
Ethics committee country [1] 315074 0
Australia
Date submitted for ethics approval [1] 315074 0
03/11/2023
Approval date [1] 315074 0
01/05/2024
Ethics approval number [1] 315074 0
2023/HE000872

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133590 0
Dr Yorgi Mavros
Address 133590 0
D18 Susan Wakil Health Building Western Avenue, The University of Sydney, Camperdown, NSW, 2006
Country 133590 0
Australia
Phone 133590 0
+61 0293519279
Fax 133590 0
Email 133590 0
[email protected]
Contact person for public queries
Name 133591 0
Yorgi Mavros
Address 133591 0
D18 Susan Wakil Health Building Western Avenue, The University of Sydney, Camperdown, NSW, 2006
Country 133591 0
Australia
Phone 133591 0
+61 0293519279
Fax 133591 0
Email 133591 0
[email protected]
Contact person for scientific queries
Name 133592 0
Yorgi Mavros
Address 133592 0
D18 Susan Wakil Health Building Western Avenue, The University of Sydney, Camperdown, NSW, 2006
Country 133592 0
Australia
Phone 133592 0
+61 0293519279
Fax 133592 0
Email 133592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22448Ethical approval    387633-(Uploaded-21-05-2024-13-01-59)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.