跳至主要内容
临床试验/NCT07675538
NCT07675538Enrolling By Invitation不适用

High-intensity Training for Adults With ADHD in Specialised Mental Health Care: A Mixed Methods Feasibility Study

Solli Distriktspsykiatriske Senter1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Feasibility of the intervention: Recruitment rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years
  • An ADHD diagnosis (F90.0 in the ICD-10)

排除标准

  • 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).

结局指标

主要结局

Feasibility of the intervention: Recruitment rate

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • In depth interview(Participants are inviteted within two weeks after ending their participation)
  • General Ability - WAIS-IV(Within two weeks before initating intervention.)
  • The Adult ADHD Self-Report Scale(Within two weeks before initating intervention. Within two weeks after ending intervention.)
  • The Working Memory Questionnaire(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Generalized Anxiety Disorder-7(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Patient Health Questionnaire-9(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Bergen Insomnia Scale(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The International Physical Activity Questionnaire(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Work and Social Adjustment Scale(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Adult ADHD Quality of Life(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • Credibility/Expectancy Questionnaire(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • The Negative Effects Questionnaire - Short Form(Within two weeks after completion of the last session.)
  • The Wechsler Memory Scale - Third Edition(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • D-KEFS Trail Making Test(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • D-KEFS Color-Word Interference Test(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • Maximal strenght(Within two weeks before first intervention session and within two weeks after completion of the last session.)
  • Maximal oxygen uptake(Within two weeks before first intervention session and within two weeks after completion of the last session.)

研究者

发起方
Solli Distriktspsykiatriske Senter
申办方类型
Other
责任方
Sponsor

研究点 (1)

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