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NCT Number: NCT05049239

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Mental Disorders Motor Activity Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro

Örebro, Örebro County, 70116, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical training

Behavioral

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.

Physical training combined with cognitive support.

Behavioral

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.

Primary outcomes

  1. Changes in Clinical Global Impression-Improvement (CGI-I)

    Time frame: 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

  2. Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1)

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 0-72, higher scores mean worse outcome

Secondary outcomes

  1. Changes in Cardio Respiratory Fitness

    Time frame: 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 outcome

  2. Changes in Balance

    Time frame: 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

  3. Changes in Body Mass Index

    Time frame: 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 outcome

  4. Changes in Abdominal Circumference

    Time frame: 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

  5. Changes in Body Awareness

    Time frame: 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.

  6. Changes in Blood pressure

    Time frame: 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.

  7. Changes in Satisfaction with Daily Occupations-Occupational Balance (SDO-OB) activity score

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 0-17, higher scores are better

  8. Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score

    Time frame: 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

  9. Changes in Canadian Occupational Performance Measure (COPM) perfomance score

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 5-50, higher scores are better

  10. Changes in Canadian Occupational Performance Measure (COPM) satisfaction score

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 5-50, higher scores are better

  11. Changes in Adult ADHD Quality of Life Measure (AAQoL)

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 29-145, higher scores are better

  12. Changes in Self Efficacy Scale (GSE-10)

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Range 0-40, higher scores are better

  13. Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscale

    Time frame: 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

  14. Changes in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale

    Time frame: 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

  15. Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale

    Time frame: 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

  16. Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scores

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    5 items scored 1-5

  17. Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global score

    Time frame: 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

  18. Changes in Continuous Performance Test (AX-CPT)

    Time frame: 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).

  19. Changes in GO/NoGO

    Time frame: 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)

  20. Changes Affective Picture series (IAPS)

    Time frame: 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)

Other outcomes

  1. Changes in Cortical thickness

    Time frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

    Structural Magnetic resonance imaging (MRI)

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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