Clinical trial NCT05049239: Structured Physical Training with and Without Cognitive Support for Adults with ADHD
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ADHD
Keywords: Physical exercise
Cognitive support
Group intervention
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Changes in Clinical Global Impression-Improvement (CGI-I)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Secondary outcomes:
measure: Changes in Cardio Respiratory Fitness
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Balance
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Body Mass Index
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Abdominal Circumference
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Body Awareness
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Blood pressure
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Satisfaction with Daily Occupations-Occupational Balance (SDO-OB) activity score
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Canadian Occupational Performance Measure (COPM) perfomance score
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Canadian Occupational Performance Measure (COPM) satisfaction score
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Adult ADHD Quality of Life Measure (AAQoL)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Self Efficacy Scale (GSE-10)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscale
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scores
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global score
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in Continuous Performance Test (AX-CPT)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes in GO/NoGO
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
measure: Changes Affective Picture series (IAPS)
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Other outcomes:
measure: Changes in Cortical thickness
timeFrame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Locations:
city: Örebro
country: Sweden
facility: Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro
Study officials:
affiliation: Örebro University and Regional Örebro County
name: Mussie Msghina, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References: