Structured Physical Training with and Without Cognitive Support for Adults with ADHD
- Conditions
- ADHD
- Interventions
- Behavioral: Physical trainingBehavioral: Physical training combined with cognitive support.
- Registration Number
- NCT05049239
- Lead Sponsor
- Region Örebro County
- Brief Summary
Studies in children and adolescents with Attention-Deficit-Hyperactivity-Disorder (ADHD) have shown that physical exercise can improve the core symptoms of ADHD; inattention and hyperactivity. For adults, the evidence is deficient and there is a great need to investigate whether adults have the same effect on ADHD symptoms of physical exercise, as children and young people have. Adults with ADHD often have a sedentary lifestyle and suffer from obesity and have sleep problems. In a normal population, these problems have been shown to be affectable with physical exercise. START (Support in Activity, Movement and Exercise) is a randomized controlled intervention study where physical exercise is given for 12 weeks, with or without cognitive support. The effect is measured with rating scales as well as cognitive and physical tests. The purpose is to investigate whether START works as a treatment for ADHD in terms of ADHD symptoms and disability, and what impact the intervention has on mental health, physical condition and activity level, body awareness and everyday functioning.
Outcome measures are registered within 3 weeks before and after the end of treatment, after 6 months and 12 months. The randomization takes place in three groups; physical exercise (i), physical exercise and extra cognitive support (ii), and control group on waiting list (iii).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Diagnosed with ADHD.
- Ongoing depression with points on MADRS-S over 21
- Suicidality
- Bipolar disorder
- Psychosis
- Ongoing addiction
- Reported threatening behavior.
- Severe autism that makes group participation impossible
- Inability to read and understand the Swedish language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical training Physical training Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks. Physical training combined with cognitive support Physical training combined with cognitive support. Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks. The cognitive support consists of person centred individual occupational therapy.
- Primary Outcome Measures
Name Time Method Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 0-72, higher scores mean worse outcome
Changes in Clinical Global Impression-Improvement (CGI-I) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Assess total improvement on a Richter scale. Range 1-7, Higher scores mean worse outcome
- Secondary Outcome Measures
Name Time Method Changes in Cardio Respiratory Fitness Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measured in millilitre per kilogram per minute with the Ekblom-Bak test, a submaximal exercise test.
Higher value means better outcomeChanges in Balance Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measured with Flamingo test. The test person is standing on the preferred leg on a low balance profile for 60 seconds. The number of times that the test person puts his/her foot to the ground is counted. Lower value means better outcome
Changes in Body Mass Index Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Weight and height will be measured in kilograms and centimeters, and combined to report BMI in kg/m\^2.
Lower value means better outcomeChanges in Abdominal Circumference Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measured with a measuring tape in centimeters. Lower value means better outcome
Changes in Body Awareness Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Body Awareness Scale - movement quality and experience (BAS MQ-E). Higher value means better outcome.
Changes in Blood pressure Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Both systolic and diastolic blood pressure will be measured in mm Hg with a blood pressure monitor on the arm.
Changes in Satisfaction with Daily Occupations-Occupational Balance (SDO-OB) activity score Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 0-17, higher scores are better
Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Global satisfaction score, range 1-5, lower scores are better
Changes in Canadian Occupational Performance Measure (COPM) perfomance score Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 5-50, higher scores are better
Changes in Canadian Occupational Performance Measure (COPM) satisfaction score Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 5-50, higher scores are better
Changes in Adult ADHD Quality of Life Measure (AAQoL) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 29-145, higher scores are better
Changes in Self Efficacy Scale (GSE-10) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Range 0-40, higher scores are better
Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscale Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start 11 items, reported as 0-100 ATMS units, higher scores are better
Changes in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start 11 items, reported as 0-100 ATMS units, higher scores are better
Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start 5 items, reported as 0-100 ATMS units, higher scores are better
Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scores Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start 5 items scored 1-5
Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global score Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start One visual-analogue-scale answer (range 0-100), higher scores are better
Changes in Continuous Performance Test (AX-CPT) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measures cognitive flexibility. Will be done in conjunction with functional Magnetic resonance imaging (fMRI).
Changes in GO/NoGO Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measures impulse control. Will be done in conjunction with functional Magnetic resonance Imaging (fMRI)
Changes Affective Picture series (IAPS) Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start Measures emotion regulation. Will be done in conjunction with functional Magnetic resonance imaging (fMRI)
Trial Locations
- Locations (1)
Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro
🇸🇪Örebro, Sweden