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Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05324085
Acronym
SO_CogEx
Enrollment
84
Registered
2022-04-12
Start date
2022-04-07
Completion date
2024-12-20
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Substance Abuse

Keywords

Exercise therapy, High-intensity interval training

Brief summary

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.

Interventions

BEHAVIORALHigh-intensity interval training

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

BEHAVIORALTreatment as usual

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.

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
Lade Behandlingssenter, Blå Kors
CollaboratorUNKNOWN
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in executive function (EF)8 weeksChange 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

MeasureTime frameDescription
Change in Stroop test score8 weeksStroop 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.
Change in Digit Span test performance8 weeksThe 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.
Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)8 weeksBDNF is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Altered serum concentration of Klotho8 weeksKlotho is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)8 weeksGpld1 is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Change in Montreal Cognitive Assessment (MoCA) score8 weeksMoCA 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.
Change in maximal cardiorespiratory fitness8 weeksMaximal cardiorespiratory fitness will be measured as oxygen uptake by cardiopulmonary exercise testing on a treadmill, by inclined walking or running on a treadmill
Change in mental distress8 weeksAlterations in mental distress will be assessed using the validated brief questionnaire Symptom Checklist-10 (SCL-10)
Change in substance use8 weeksChange in substance use will be assessed using a simple self-report questionnaire
Change in substance craving8 weeksChange in substance use will be assessed using a simple Visual Analogue Scale ranging from 0 (no craving) to 10 (severe craving)
Change in quality of life8 weeksQuality of life will be assessed with a brief version of the World Health Organization Quality of Life assessment
Altered serum concentration of interleukin 6 (IL6)8 weeksIL6 is a muscle-secreted protein known to affect neurocognitive/neuroprotective mechanisms

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026