Attention Deficit Disorder With Hyperactivity (ADHD)
Conditions
Keywords
ADHD, Physical exercise, High intensity training
Brief summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is a lifelong neurodevelopmental disorder characterised by persistent symptoms of inattention, hyperactivity, and impulsivity. According to the DSM-5, these symptoms must be present for at least six months, have an onset in childhood, and result in significant impairment in multiple life domains. Although ADHD may be limited to childhood in some cases, most individuals continue to have symptoms and impairments in varying degrees in adult life. The prevalence of persistent ADHD among adults is estimated to be approximately 2.58%, depending on diagnostic criteria and sample selection. The increasing awareness of ADHD has led to a marked increase in referrals to mental health services, which places greater demands on the development of effective and accessible treatment options for this group. Pharmacological treatment, particularly the use of stimulants, is a common intervention for adults with ADHD and has been shown to be effective for many. However, there are also side effects associated with drug treatment, and there is a need for more evidence-based non-drug alternatives. In addition, discontinuation of medication is common in ADHD treatment. Psychological interventions include psychoeducation and cognitive behaviour therapy, as well as more specialised approaches based on Dialectical Behaviour Therapy and Goal Management Training, which aim to improve executive functions. Whilst pharmacotherapy and psychotherapeutic interventions help some people with ADHD, not all people experience favourable outcomes, which calls for alternative treatment approaches. Interventions targeting the core symptoms of ADHD, executive functions, and behaviour are particularly relevant to treatment provision. One approach to improving executive functioning that has received increasing attention is physical exercise. Studies have shown that physical activity can have a positive effect on cognitive function, executive control, and behaviour in children and adolescents with ADHD. Physical exercise may also be applied as treatment for comorbid factors common in ADHD, such as mood disorders and multiple long-term physical conditions. Despite increasing interest in physical activity as a treatment modality, research on physical exercise for adults with ADHD is still limited. The findings from studies on younger age groups point to the potential for similar effects in adults, but more research is needed to examine the effects of physical exercise as a targeted intervention in the adult population with ADHD. Among the different types of physical activity, high-intensity interval training (HIIT) has gained promise for mental health. Due to its rapid, alternating, and fast-paced style, it could prove useful for those with ADHD. However, research on high-intensity interval training interventions (HIIT) in this population is scarce. To address these unanswered questions, this project will conduct a feasibility trial for a randomised controlled trial (RCT) to assess the feasibility and acceptability of HIIT among people with ADHD.
Interventions
BEHAVIORALHigh intensity training
14 weeks of high intensity training of strenght and endurace.
Sponsors
Solli Distriktspsykiatriske Senter
Helse Bergen Hospital Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Above 18 years * An ADHD diagnosis (F90.0 in the ICD-10)
Exclusion criteria
* Psychiatric conditions not compatible with participation incl. ongoing psychotic episode, mania, acute suicidality etc., * Physical conditions precluding participation in physical testing and/or exercise * Comprehensive ongoing substance use determined by the Alcohol Use Disorders IdentificationTest (AUDIT; Babor et al., 2001) and the Drug Use Disorder Identification Test (DUDIT; Berman et al., 2003). An AUDIT cut-off score of 16 (high risk), and/or DUDIT score of 20 (high risk) will lead to screening with MINI International Neuropsychiatric Interview (Lecrubier etal., 1997; Sheehan et al., 1998).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention: Recruitment rate | through study completion, an average of 1 year | Recruitment rate: Proportion of eligible participants who agree to participate in the study ((Number of participants recruited/Number of eligible participants) x 100). Aim: \>50%. |
| Feasibility measure: Retention rate | through study completion, an average of 1 year | Retention rate: Proportion of participants who remain in the study until completion ((Number of participants completing the study/Number of participants enrolled) x 100). Aim: \>80%. |
| Feasibility measure: Dropout rate | through study completion, an average of 1 year | Dropout rate: How many participants dropped out after inclusion. Registration of reasons of dropout. |
| Feasibility measure: Compliance | through study completion, an average of 1 year | Compliance: How many sessions each participant attended. Registration of reasons of sessions not attended. |
| Feasibility measure: Adherence to protocol | through study completion, an average of 1 year | Adherence to protocol: How many elements in the physical exercise program were conducted in each session. Physical exercise diary for registration of load and intensity of strength- and endurance training, respectively. Aim: \>80%. Also, registration of adherence to the total test protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Wechsler Memory Scale - Third Edition | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Wechsler Memory Scale - Third Edition (WMS-III) Spatial Memory subtest is a clinician-administered measure of visuospatial memory. Standardized age-adjusted scores are derived, with higher scores indicating better spatial memory performance and lower scores indicating poorer spatial memory. |
| D-KEFS Trail Making Test | Within two weeks before first intervention session and within two weeks after completion of the last session. | The D-KEFS Trail Making Test is a clinician-administered measure of executive function assessing visual scanning, processing speed, and cognitive flexibility. Performance is measured by time to completion and standardized scaled scores, with higher scores (and faster completion times) indicating better executive functioning." |
| D-KEFS Color-Word Interference Test | Within two weeks before first intervention session and within two weeks after completion of the last session. | The D-KEFS Color-Word Interference Test is a clinician-administered measure of executive function assessing response inhibition and cognitive flexibility. Performance is measured by time to completion and standardized scaled scores, with higher scores (and faster completion times) indicating better executive functioning. |
| In depth interview | Participants are inviteted within two weeks after ending their participation | Participants will be invited to an in-depth interview lasting approx. 45 minutes, after the treatment intervention. The aim is to explore experiences with physical exercise in relation to core symptoms of ADHD. A semi-structured interview protocol with open questions and additional probes is used to promote exploratory dialogue on the participants experience with participation. All interviews will be audio recorded and transcribed verbatim. By comparing the individual accounts, we want to identify both patterns of commonalities and differences in participants' experiences, providing important descriptions of patient experiences that may contribute to detect challenges with the intervention that can be utilised for further development and implementation. |
| General Ability - WAIS-IV | Within two weeks before initating intervention. | Six sub tests from the general ability test Wecshler Adult Intelligence Scale will be used to assess General Ability Index, Verbal Comprehension Index and Perceptual Reasoning Index. The six subtests are: Block Design, Similarities, Matrix Reasoning, Vocabulary, Digit Span and Coding. |
| The Adult ADHD Self-Report Scale | Within two weeks before initating intervention. Within two weeks after ending intervention. | The Adult ADHD Self-Report Scale (ASRS) is a patient-reported outcome measure assessing the frequency and severity of adult ADHD symptoms. Items are rated on a 5-point Likert scale (0-4), with higher total scores reflecting greater ADHD symptom severity. Lower scores reflect fewer self-reported ADHD symptoms. |
| The Working Memory Questionnaire | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Working Memory Questionnaire (WMQ) is a patient-reported outcome measure designed to assess everyday difficulties related to working memory functioning. It evaluates the frequency of memory-related problems experienced in daily life, including difficulties with remembering information, maintaining attention, following instructions, and managing cognitive tasks. The WMQ consists of items rated on a Likert-type scale, where participants indicate how often they experience specific working memory difficulties. A total score is calculated by summing item responses. Higher scores indicate greater perceived working memory difficulties and a higher level of impairment in everyday cognitive functioning. Lower scores indicate fewer reported working memory problems and better perceived working memory functioning. The total WMQ score is calculated by summing responses across items (with item scoring depen |
| The Generalized Anxiety Disorder-7 | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Generalized Anxiety Disorder-7 (GAD-7) is a patient-reported outcome measure assessing anxiety symptom severity. Items are scored from 0-3 based on symptom frequency over the previous two weeks, producing a total score from 0-21. Higher scores indicate greater anxiety symptom severity, while lower scores indicate fewer anxiety symptoms |
| The Patient Health Questionnaire-9 | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Patient Health Questionnaire-9 (PHQ-9) is a patient-reported outcome measure assessing depressive symptom severity. Items are scored from 0-3 based on symptom frequency over the previous two weeks, producing a total score from 0-27. Higher scores indicate greater depressive symptom severity, while lower scores indicate fewer depressive symptoms. |
| The Bergen Insomnia Scale | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Bergen Insomnia Scale (BIS) is a patient-reported outcome measure assessing insomnia symptoms and sleep-related impairment. Six items are rated from 0-7 according to symptom frequency over the previous month, producing a total score from 0-42. Higher scores indicate greater insomnia symptom severity, while lower scores indicate fewer insomnia symptoms. |
| The International Physical Activity Questionnaire | Within two weeks before first intervention session and within two weeks after completion of the last session. | The International Physical Activity Questionnaire (IPAQ) is a patient-reported outcome measure assessing physical activity and sedentary behavior. It measures frequency and duration of walking, moderate-intensity, and vigorous-intensity activities over a specified recall period. Scores are calculated as MET-minutes/week, with higher scores indicating greater physical activity and lower scores indicating less physical activity. |
| The Work and Social Adjustment Scale | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Work and Social Adjustment Scale (WSAS) is a patient-reported outcome measure assessing functional impairment associated with a health condition. Five items are rated from 0-8, producing a total score from 0-40. Higher scores indicate greater impairment in work, social, and daily functioning, while lower scores indicate better functioning. |
| The Adult ADHD Quality of Life | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Adult ADHD Quality of Life (AAQoL) is a validated self-report questionnaire designed to assess health-related quality of life in adults with attention-deficit/hyperactivity disorder (ADHD). The instrument evaluates the impact of ADHD symptoms on daily functioning and well-being across multiple domains, including life productivity, psychological health, relationships, and outlook. The AAQoL consists of 29 items, each rated on a Likert-type scale reflecting the frequency or severity of difficulties experienced over a specified recall period. Item responses are combined and transformed into domain scores and an overall total score. Item responses are aggregated and converted to standardized scores ranging from \*\*0 to 100\*\* for the total scale and each domain. Higher scores indicate better health-related quality of life, while lower scores indicate poorer quality of life and greater ADHD-related f |
| Credibility/Expectancy Questionnaire | Within two weeks before first intervention session and within two weeks after completion of the last session. | The Credibility/Expectancy Questionnaire (CEQ) is a patient-reported measure assessing perceived treatment credibility and expectancy for improvement. It consists of 5 items where patients rate themselves on a likert scale from 0-10. It produces a total scores, with higher scores indicating greater perceived credibility and stronger expectations of treatment benefit. |
| The Negative Effects Questionnaire - Short Form | Within two weeks after completion of the last session. | The Negative Effects Questionnaire - Short Form (NEQ-S) is a patient-reported outcome measure assessing perceived negative or unwanted effects of an intervention. Higher scores indicate a greater number and/or severity of self-reported adverse effects. |
| Maximal strenght | Within two weeks before first intervention session and within two weeks after completion of the last session. | Maximal strength is assessed using the one-repetition maximum (1RM) test for lower-body and upper-body strength. In this study, maximal lower-body strength is assessed using a leg strength exercise (e.g., leg press or squat depending on protocol), and upper-body strength is assessed using the bench press. The primary outcome is the maximal load lifted successfully for one repetition, recorded in kilograms (kg). Separate 1RM values are obtained for leg strength and bench press. Higher scores: Indicate greater maximal muscular strength and neuromuscular performance in the tested muscle groups. Lower score |
| Maximal oxygen uptake | Within two weeks before first intervention session and within two weeks after completion of the last session. | Maximal oxygen uptake (VO₂max) is an estimate of the maximum rate at which oxygen can be utilized during intense aerobic exercise and is a key indicator of cardiorespiratory fitness. In this study, VO₂max is estimated using the Myworkout GO mobile application (Helgerud et al., 2022), which derives VO₂max from performance data collected during a standardized treadmill-based interval protocol (4×4 endurance session). The estimation is based on recorded treadmill speed and incline during the exercise session, which are used to model aerobic capacity according to validated predictive algorithms. VO₂max is reported as an estimated continuous variable in milliliters of oxygen per kilogram of body weight per minute (mL·kg-¹·min-¹). Higher values indicate greater aerobic capacity and cardiorespiratory fitness, while lower values indicate reduced aerobic fitness. |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORKristine Sirevåg, PhD
Solli DPS
Outcome results
None listed