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

NCT05049239 | Active Not Recruiting

• 1 other identifier: OLL-274569
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Keywords

Physical exercise; Cognitive support; Group intervention

Outcome Measures

Primary Outcomes (2)

• Changes in Clinical Global Impression-Improvement (CGI-I)

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

  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

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

Secondary Outcomes (20)

• Changes in Cardio Respiratory Fitness

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

• Changes in Balance

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

• Changes in Body Mass Index

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

• Changes in Abdominal Circumference

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

• Changes in Body Awareness

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

Other Outcomes (1)

• Changes in Cortical thickness

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

Study Arms (3)

Physical training

EXPERIMENTAL

Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks.

Behavioral: Physical training

Physical training combined with cognitive support

ACTIVE COMPARATOR

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.

Behavioral: Physical training combined with cognitive support.

Control group

NO INTERVENTION

The control group receive no intervention.

Interventions

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

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.

Physical training combined with cognitive support

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ADHD.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro

Örebro, Örebro County, 70116, Sweden

Location

Related Publications (3)

• 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.

  PMID: 41244864 DERIVED

• 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.

  PMID: 37749523 DERIVED

• 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.

  PMID: 37255729 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mussie Msghina, Assoc.Prof

  Örebro University and Regional Örebro County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: September 20, 2021
• Study Start: February 15, 2021
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available from study start to the end of the study
• Access Criteria: To get access the person have to be involved in all parts of the study. Access is decided by PI. Access to data is password protected in accordance with the European General Data Protection Regulation (GDPR).

Locations

SE (1)