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

NCT ID: NCT05049239

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical training

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

Group Type: EXPERIMENTAL

Physical training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Physical training combined with cognitive support.

Intervention Type: 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.

Control group

The control group receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical 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.

Intervention Type: BEHAVIORAL

Physical 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mussie Msghina, Assoc.Prof

Role: PRINCIPAL_INVESTIGATOR

Örebro University and Regional Örebro County

Locations

Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro

Örebro, Örebro County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 37749523 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37255729 (View on PubMed)

Other Identifiers

OLL-274569

Identifier Type: -

Identifier Source: org_study_id