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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Physical training; Behavioral: Physical training combined with cognitive support.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mussie Msghina, Assoc.prof; Phone Number: +46 19 6025659; Email: mussie.msghina@regionorebrolan.se
• Study Contact Backup: Name: Kajsa Lidström Holmqvist, PhD; Phone Number: +46 70 5554587; Email: kajsa.lidstrom-holmqvist@regionorebrolan.se

Study Locations

• Sweden
  • Örebro, Sweden, 70116
    • Recruiting
    • Öppenvårdspsykiatrisk mottagning, Universitetssjukhuset Örebro
    • Contact: Mussie Msghina, Assoc.prof; Phone Number: +46 19 6025659; Email: mussie.msghina@regionorebrolan.se
    • Contact: Lena Axelsson Svedell, PhD stud; Phone Number: +46 19 6029251; Email: lena.axelsson-svedell@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical training; Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks.	Behavioral: 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.
Active Comparator: 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.	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.
No Intervention: Control group; The control group receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Cardio Respiratory Fitness	Measured in millilitre per kilogram per minute with the Ekblom-Bak test, a submaximal exercise test. Higher value means better outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Grip Strength	Measured in kilogram with JAMAR hand dynamometer. Higher value means better outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Balance	Measured with Flamingo test. The test person is standing on the preferred leg on a low balance profile for 60 seconds. The number of times that the test person puts his/her foot to the ground is counted. Lower value means better outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Body Mass Index	Weight and height will be measured in kilograms and centimeters, and combined to report BMI in kg/m^2. Lower value means better outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Abdominal Circumference	Measured with a measuring tape in centimeters. Lower value means better outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Body Awareness	Body Awareness Scale - movement quality and experience (BAS MQ-E). Higher value means better outcome.	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Blood pressure	Both systolic and diastolic blood pressure will be measured in mm Hg with a blood pressure monitor on the arm.	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	Range 0-17, higher scores are better	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	Global satisfaction score, range 1-5, lower scores are better	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Canadian Occupational Performance Measure (COPM) perfomance score	Range 5-50, higher scores are better	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Canadian Occupational Performance Measure (COPM) satisfaction score	Range 5-50, higher scores are better	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Adult ADHD Quality of Life Measure (AAQoL)	Range 29-145, higher scores are better	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Self Efficacy Scale (GSE-10)	Range 0-40, higher scores are better	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	11 items, reported as 0-100 ATMS units, higher scores are better	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	11 items, reported as 0-100 ATMS units, higher scores are better	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	5 items, reported as 0-100 ATMS units, higher scores are better	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	5 items scored 1-5	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	One visual-analogue-scale answer (range 0-100), higher scores are better	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in Continuous Performance Test (AX-CPT)	Measures cognitive flexibility. Will be done in conjunction with functional Magnetic resonance imaging (fMRI).	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in GO/NoGO	Measures impulse control. Will be done in conjunction with functional Magnetic resonance Imaging (fMRI)	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes Affective Picture series (IAPS)	Measures emotion regulation. Will be done in conjunction with functional Magnetic resonance imaging (fMRI)	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood hemoglobin levels (Hb)	Used to assess general health and to screen for conditions that affect red blood cells. Is measured in g/L. Low and high balus indicate worse outcome.	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood platelet count (PC/TBK)	Used to assess general health and screen for conditions that affect blood platelets. Is measued in10*9/L. Low and high values indicate worse outcome.	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood leukocyte count (WBC / LPK)	Used to Asses general health and screen for changes in white blood count. Is measured in 10*6/L. Low and high values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in plasma alanine transaminase levels (ALT /ALAT)	Part of the hepatic panel used to assess general health related to liver disease. Is measured in microkat/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in plasma aspartate aminotransferase levels (AST /ASAT)	Part of hepatic panel used to assess general health related to liver disease. Is measured in microkat/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in plasma thyroid-stimulating hormone levels (TSH)	Part of general health screening to assess the function of the thyroid hormone. Is measured in mIE/L. Low and high values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in plasma creatinine levels (Krea)	Part of a general health screening to assess the function of the kidneys. Is measured in micromol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in serum sodium leves (s-Na)	Part of a general health screening to assess electrolyte balance. Is measured in mmol/L. Low and high values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in serum potassium levels (s-K)	Part of a general health screening to assess electrolyte balance. Is measured in mmol/L. Low and high values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood phosphatidylethanol levels (PeTH)	A test to assess alcohol overconsumption. Is measured in micromol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in high-sensitivity plasma C-reactive protein levels (CRP-high sensitive).	Assesses general levels of inflammation in the body. Is measured in mg/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood interleukin- 6 levels (IL-6)	A marker of immune system activation. Is measured in ng/L. High values indicate worse outcome.	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in blood hemoglobin A1c levels (HbA1c)	Assesses the level of sugar attached to hemoglobin and indicates the level of blood sugar of the past 2-3 months. Is measured in mmol/mol. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in total plasma cholesterol levels (cholesterol)	Assesses cardiovascular disease risk. Is measured in mmol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in HDL plasma cholesterol levels (HDL-cholesterol)	Assesses cardiovascular disease risk. Is measured in mmol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in LSL plasma cholesterol levels (LDL-cholesterol	Assesses cardiovascular disease risk. Is measured in mmol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start
Changes in plasma triglyceride levels	Assesses cardiovascular disease risks. Is measured in mmol/L. High values indicate worse outcome	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Cortical thickness	Structural Magnetic resonance imaging (MRI)	Pre-intervention, post-intervention (12 weeks) and 3, 6 and 12 months after intervention start

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Mussie Msghina, Assoc.Prof, Örebro University and Regional Örebro County

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Physical exercise; Cognitive support; Group intervention
• Other Study ID Numbers: OLL-274569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared with researchers within the research group only.
• IPD Sharing Time Frame: Data will become available from study start to the end of the study
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No