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Completed

NCT Number: NCT05324085

Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder

Impaired cognitive function is common among patients with substance use disorder (SUD). This is particularly related to executive functions (EF), which includes abilities like decision-making, consequence analysis and impulse/self-control. EF is recognized as an important determinant of treatment outcome as it is associated with dropout rate, attendance to therapy sessions and absence of relapse following treatment termination. Exercise seem to improve cognitive/executive functions, particularly in individuals with cognitive impairments. Aerobic exercise also affects signaling substances and growth factors known to inhibit neural degeneration, and improves cerebral insulin sensitivity and blood flow, contributing to improved brain function. There is a lack of knowledge regarding how to improve EF in SUD patients, and whether such improvements can benefit other parts of the treatment, such as psychotherapy. Aerobic exercise is a well-recognized and cost-effective intervention for cardiovascular and metabolic health, with promising effects on cognitive/executive functions. A randomized controlled trial will be carried out to investigate the effects of aerobic exercise on EF, molecular markers of neuroplasticity and brain function, and treatment outcome in SUD patients. The investigators expect to achieve new knowledge regarding cognitive impairment among SUD patients and to what extent aerobic exercise can improve cognitive abilities and treatment outcome.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lade Behandlingssenter, Blåkors

Trondheim, Trøndelag, 7041, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed substance use disorder (SUD) by ICD-10
  • Being in residential inpatient treatment for SUD at Lade Addiction Treatment Center

Exclusion criteria

  • Recent participation in regular aerobic high-intensity interval training (HIIT)
  • Admissions shorter than 12 weeks
  • Pregnant
  • History of brain injury (except concussions)
  • Any acute or chronic somatic or psychiatric condition (e.g. heart disease or psychosis) or a medication that would limit the ability to participate in the exercise training and testing procedures, or any of the other assessments.

Treatment and study plan

High-intensity interval training

Behavioral

Supervised exercise intervention, three times a week for eight weeks.

Other names: HIIT

Treatment as Usual

Behavioral

The content of TAU is broadly individualized but most often includes various forms of group therapy, psychotherapy, psychoeducation and physical activity. The physical activity schedule for the patients typically includes gym-based exercises, individualized by preference of each patient, and various outdoors activities, four times per week all together.

Primary outcomes

  1. Change in executive function (EF)

    Time frame: 8 weeks

    Change in executive function assessed with Behavior Rating Inventory of ExecutiveFunction, Adult (BRIEF-A). BRIEF-A is a 75-item standardized questionnaire appraising EFs in real-life situations. It incorporates self-reported cognitive characteristics and collects subjective information about the ability to maintain appropriate control of emotional responses and behavior.

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) score

    Time frame: 8 weeks

    MoCA is a brief neuropsychological assessment to evaluate cognitive function in various domains (i.e. visuospatial/executive abilities, naming, memory, attention, language, abstraction, and orientation). This assessment takes about 10 minutes to perform. Maximum score is 30, but scores from 26 and above is considered normal.

  2. Change in Stroop test score

    Time frame: 8 weeks

    Stroop is a widely used and validated test evaluate attention and impulse control. This particular test allow 90 seconds to solve as many problems as possible. Each correct answer provides one point, while incorrect answers are subtracted from the total score.

  3. Change in Digit Span test performance

    Time frame: 8 weeks

    The Digit Span test is an assessment of working memory, using rows of numbers that should be memorized. Each correct answer provides one point with the following sequence being one digit longer than the previous. The test has no limit on time or upper score, but only allows three mistakes before ending.

  4. Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)

    Time frame: 8 weeks

    BDNF is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum

  5. Altered serum concentration of Klotho

    Time frame: 8 weeks

    Klotho is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum

  6. Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)

    Time frame: 8 weeks

    Gpld1 is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum

  7. Altered serum concentration of interleukin 6 (IL6)

    Time frame: 8 weeks

    IL6 is a muscle-secreted protein known to affect neurocognitive/neuroprotective mechanisms

  8. Change in maximal cardiorespiratory fitness

    Time frame: 8 weeks

    Maximal cardiorespiratory fitness will be measured as oxygen uptake by cardiopulmonary exercise testing on a treadmill, by inclined walking or running on a treadmill

  9. Change in mental distress

    Time frame: 8 weeks

    Alterations in mental distress will be assessed using the validated brief questionnaire Symptom Checklist-10 (SCL-10)

  10. Change in substance use

    Time frame: 8 weeks

    Change in substance use will be assessed using a simple self-report questionnaire

  11. Change in substance craving

    Time frame: 8 weeks

    Change in substance use will be assessed using a simple Visual Analogue Scale ranging from 0 (no craving) to 10 (severe craving)

  12. Change in quality of life

    Time frame: 8 weeks

    Quality of life will be assessed with a brief version of the World Health Organization Quality of Life assessment

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Lade Behandlingssenter, Blå Kors
  • Norwegian University of Science and Technology

Registry information

Official study title

Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder: a Randomized Controlled Trial

Acronym: SO_CogEx

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2022
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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