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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- Region Örebro County
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Changes in Adult ADHD Self-Report Scale (ASRS-v.1.1)
Time Frame: Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Range 0-72, higher scores mean worse outcome
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
Assess total improvement on a Richter scale. Range 1-7, Higher scores mean worse outcome
Secondary Outcomes
- 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)
- Changes in Blood pressure(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Satisfaction with Daily Occupations-Occupational Balance (SDO-OB) activity score(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Canadian Occupational Performance Measure (COPM) perfomance score(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Canadian Occupational Performance Measure (COPM) satisfaction score(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Adult ADHD Quality of Life Measure (AAQoL)(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Self Efficacy Scale (GSE-10)(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Assessment of Time Management Skills-Swedish (ATMS-S) Time management subscale(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): item scores(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L): global score(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in Continuous Performance Test (AX-CPT)(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes in GO/NoGO(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)
- Changes Affective Picture series (IAPS)(Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start)