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Structured Physical Training with and Without Cognitive Support for Adults with ADHD

Support in Activity, Movement and Exercise-for Adults with ADHD. a Randomized Controlled Trial Intervention Study with 12 Weeks of Physical Training with and Without Cognitive Support.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049239
Enrollment
75
Registered
2021-09-20
Start date
2021-02-15
Completion date
2026-12-31
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

Physical exercise, Cognitive support, Group intervention

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).

Interventions

BEHAVIORALPhysical training

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.

BEHAVIORALPhysical training combined with cognitive support.

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.

Sponsors

Region Örebro County
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with ADHD.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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 startRange 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 startAssess total improvement on a Richter scale. Range 1-7, Higher scores mean worse outcome

Secondary

MeasureTime frameDescription
Changes in BalancePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startMeasured 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 IndexPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startWeight and height will be measured in kilograms and centimeters, and combined to report BMI in kg/m\^2. Lower value means better outcome
Changes in Abdominal CircumferencePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startMeasured with a measuring tape in centimeters. Lower value means better outcome
Changes in Body AwarenessPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startBody Awareness Scale - movement quality and experience (BAS MQ-E). Higher value means better outcome.
Changes in Blood pressurePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startBoth 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 scorePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startRange 0-17, higher scores are better
Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction scorePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startGlobal satisfaction score, range 1-5, lower scores are better
Changes in Canadian Occupational Performance Measure (COPM) perfomance scorePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startRange 5-50, higher scores are better
Changes in Canadian Occupational Performance Measure (COPM) satisfaction scorePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startRange 5-50, 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 startRange 0-40, higher scores are better
Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscalePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start11 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 scalePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start11 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 scalePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start5 items, reported as 0-100 ATMS units, higher scores are better
Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scoresPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start5 items scored 1-5
Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global scorePre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startOne 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 startMeasures cognitive flexibility. Will be done in conjunction with functional Magnetic resonance imaging (fMRI).
Changes in GO/NoGOPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startMeasures 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 startMeasures emotion regulation. Will be done in conjunction with functional Magnetic resonance imaging (fMRI)
Changes in Adult ADHD Quality of Life Measure (AAQoL)Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startRange 29-145, higher scores are better
Changes in Cardio Respiratory FitnessPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startMeasured in millilitre per kilogram per minute with the Ekblom-Bak test, a submaximal exercise test. Higher value means better outcome

Other

MeasureTime frameDescription
Changes in Cortical thicknessPre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention startStructural Magnetic resonance imaging (MRI)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026