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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks, consisting of fitness, strength and mobility exercises with a target level of 60-90% of maximum heart rate. Two sessions per week take place in a group led by a physiotherapist and once a week the training consists of self-chosen training individually or in group.
Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks, consisting of fitness, strength and mobility exercises with a target level of 60-90% of maximum heart rate. Two sessions per week take place in a group led by a physiotherapist and once a week the training consists of self-chosen training individually or in group. The cognitive support consists of person centred individual occupational therapy with focus on daily time management skills and planning and organisation in daily life, i.e. make time for physical exercise. The number of session during the intervention period depend on the participants needs and is estimated to 4-6 sessions.
Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden
Changes in Clinical Global Impression-Improvement (CGI-I)
Assess total improvement on a Richter scale. Range 1-7, Higher scores mean worse outcome
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1)
Range 0-72, higher scores mean worse outcome
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Cardio Respiratory Fitness
Measured in millilitre per kilogram per minute with the Ekblom-Bak test, a submaximal exercise test. Higher value means better outcome
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Balance
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
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Body Mass Index
Weight and height will be measured in kilograms and centimeters, and combined to report BMI in kg/m\^2. Lower value means better outcome
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Abdominal Circumference
Measured with a measuring tape in centimeters. Lower value means better outcome
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Body Awareness
Body Awareness Scale - movement quality and experience (BAS MQ-E). Higher value means better outcome.
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Blood pressure
Both systolic and diastolic blood pressure will be measured in mm Hg with a blood pressure monitor on the arm.
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Satisfaction with Daily Occupations-Occupational Balance (SDO-OB) activity score
Range 0-17, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score
Global satisfaction score, range 1-5, lower scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Canadian Occupational Performance Measure (COPM) perfomance score
Range 5-50, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Canadian Occupational Performance Measure (COPM) satisfaction score
Range 5-50, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Adult ADHD Quality of Life Measure (AAQoL)
Range 29-145, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Self Efficacy Scale (GSE-10)
Range 0-40, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscale
11 items, reported as 0-100 ATMS units, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale
11 items, reported as 0-100 ATMS units, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale
5 items, reported as 0-100 ATMS units, higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scores
5 items scored 1-5
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global score
One visual-analogue-scale answer (range 0-100), higher scores are better
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Continuous Performance Test (AX-CPT)
Measures cognitive flexibility. Will be done in conjunction with functional Magnetic resonance imaging (fMRI).
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in GO/NoGO
Measures impulse control. Will be done in conjunction with functional Magnetic resonance Imaging (fMRI)
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes Affective Picture series (IAPS)
Measures emotion regulation. Will be done in conjunction with functional Magnetic resonance imaging (fMRI)
Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
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