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

Region Örebro County

Status: Active, not recruiting

Conditions: ADHD

Treatments: Behavioral: Physical training; Behavioral: Physical training combined with cognitive support.

Study type: Interventional

Funder types: Other

Identifiers

NCT05049239

OLL-274569

Details and patient eligibility

About

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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Physical training

Experimental group

Description:

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

Treatment:

Behavioral: Physical training

Physical training combined with cognitive support

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical training combined with cognitive support.

Control group

No Intervention group

Description:

The control group receive no intervention.