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ADHDNCT05049239

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

A study testing Physical training and Physical training combined with cognitive support. in people with ADHD, run by Region Örebro County at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
ADHD
What is being tested?
Physical training and Physical training combined with cognitive support.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSweden
Study dates
15 Feb 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with ADHD.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro

    Örebro, Örebro County, 70116

Other trials in Sweden

About this study

Official 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.

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).

Conditions
ADHD
Being tested
Physical training, Physical training combined with cognitive support.
Keywords
Physical exercise, Cognitive support, Group intervention
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical trainingBehavioural

    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.Behavioural

    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.

Study groups in NCT05049239
Study groupRoleWhat they receive
Physical trainingExperimentalMedium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks.
Receives: Behavioral: Physical training
Physical training combined with cognitive supportActive comparatorMedium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks. The cognitive support consists of person centred individual occupational therapy.
Receives: Behavioral: Physical training combined with cognitive support.
Control groupNo interventionThe control group receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Assess total improvement on a Richter scale. Range 1-7, Higher scores mean worse outcome

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

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

    Range 0-72, higher scores mean worse outcome

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

Secondary outcomes (20)

  1. 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

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

  2. 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

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

  3. 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

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

  4. Changes in Abdominal Circumference

    Measured with a measuring tape in centimeters. Lower value means better outcome

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

  5. Changes in Body Awareness

    Body Awareness Scale - movement quality and experience (BAS MQ-E). Higher value means better outcome.

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

  6. Changes in Blood pressure

    Both systolic and diastolic blood pressure will be measured in mm Hg with a blood pressure monitor on the arm.

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

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

    Range 0-17, higher scores are better

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

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

    Global satisfaction score, range 1-5, lower scores are better

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

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

    Range 5-50, higher scores are better

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

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

    Range 5-50, higher scores are better

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

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

    Range 29-145, higher scores are better

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

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

    Range 0-40, higher scores are better

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

  13. 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

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

  14. 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

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

  15. 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

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

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

    5 items scored 1-5

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

  17. 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

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

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

    Measures cognitive flexibility. Will be done in conjunction with functional Magnetic resonance imaging (fMRI).

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

  19. Changes in GO/NoGO

    Measures impulse control. Will be done in conjunction with functional Magnetic resonance Imaging (fMRI)

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

  20. Changes Affective Picture series (IAPS)

    Measures emotion regulation. Will be done in conjunction with functional Magnetic resonance imaging (fMRI)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start15 Feb 2021
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049239
Sponsor's protocol ID
OLL-274569
Status last verified
Mar 2025
First submitted
14 May 2021
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared with researchers within the research group only.

Publications

  • Svedell LA, Lindvall MA, Holmqvist KL, Cao Y, Msghina M. Physical exercise as add-on treatment in adults with ADHD - the START study: a randomized controlled trial. Front Psychiatry. 2025 Oct 30;16:1690216. doi: 10.3389/fpsyt.2025.1690216. eCollection 2025.

    PubMed 41244864

  • Lindvall MA, Holmqvist KL, Svedell LA, Philipson A, Cao Y, Msghina M. START - physical exercise and person-centred cognitive skills training as treatment for adult ADHD: protocol for a randomized controlled trial. BMC Psychiatry. 2023 Sep 25;23(1):697. doi: 10.1186/s12888-023-05181-1.

    PubMed 37749523

  • Svedell LA, Holmqvist KL, Lindvall MA, Cao Y, Msghina M. Feasibility and tolerability of moderate intensity regular physical exercise as treatment for core symptoms of attention deficit hyperactivity disorder: a randomized pilot study. Front Sports Act Living. 2023 May 15;5:1133256. doi: 10.3389/fspor.2023.1133256. eCollection 2023.

    PubMed 37255729

Questions about this trial

What is this clinical trial studying?

A study testing Physical training and Physical training combined with cognitive support. in people with ADHD, run by Region Örebro County at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049239, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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