Substance AbuseSO_CogExNCT05324085
Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder
A study testing High-intensity interval training and Treatment as usual in people with Substance Abuse and Cognitive Dysfunction, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Cognitive Dysfunction
- What is being tested?
- High-intensity interval training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNorway
- Study dates
- 7 Apr 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed substance use disorder (SUD) by ICD-10
- Being in residential inpatient treatment for SUD at Lade Addiction Treatment Center
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder: a Randomized Controlled Trial
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.
- Conditions
- Substance Abuse, Cognitive Dysfunction
- Being tested
- High-intensity interval training, Treatment as usual
- Keywords
- Exercise therapy, High-intensity interval training
- Medical subject headings
- Substance-Related Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Also called HIIT
Supervised exercise intervention, three times a week for eight weeks.
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention group | Experimental | Participants will undergo supervised treadmill exercise three times each week for eight weeks, in addition to treatment as usual (TAU). Receives: Behavioral: High-intensity interval training; Behavioral: Treatment as usual |
| Control group | Other | Participants will undergo TAU. 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive function (EF)
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.
Measured: 8 weeks
Secondary outcomes (12)
Change in Montreal Cognitive Assessment (MoCA) score
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.
Measured: 8 weeks
Change in Stroop test score
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.
Measured: 8 weeks
Change in Digit Span test performance
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.
Measured: 8 weeks
Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)
BDNF is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Measured: 8 weeks
Altered serum concentration of Klotho
Klotho is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Measured: 8 weeks
Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)
Gpld1 is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Measured: 8 weeks
Altered serum concentration of interleukin 6 (IL6)
IL6 is a muscle-secreted protein known to affect neurocognitive/neuroprotective mechanisms
Measured: 8 weeks
Change in maximal cardiorespiratory fitness
Maximal cardiorespiratory fitness will be measured as oxygen uptake by cardiopulmonary exercise testing on a treadmill, by inclined walking or running on a treadmill
Measured: 8 weeks
Change in mental distress
Alterations in mental distress will be assessed using the validated brief questionnaire Symptom Checklist-10 (SCL-10)
Measured: 8 weeks
Change in substance use
Change in substance use will be assessed using a simple self-report questionnaire
Measured: 8 weeks
Change in substance craving
Change in substance use will be assessed using a simple Visual Analogue Scale ranging from 0 (no craving) to 10 (severe craving)
Measured: 8 weeks
Change in quality of life
Quality of life will be assessed with a brief version of the World Health Organization Quality of Life assessment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start7 Apr 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors
- Responsible party
- Sponsor
- Investigators
- Mats P Mosti, PhD, Principal investigator, Department of Research and Development, St. Olavs University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324085
- Sponsor's protocol ID
- 171845
- Other IDs
- 3253020430
- Acronym
- SO_CogEx
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan in progress
Publications
Haberstroh C, Weider S, Flemmen G, Loe H, Andersson HW, Hallgren M, Mosti MP. The effect of high-intensity interval training on cognitive function in patients with substance use disorder: Study protocol for a two-armed randomized controlled trial. Front Sports Act Living. 2022 Dec 9;4:954561. doi: 10.3389/fspor.2022.954561. eCollection 2022.
PubMed 36570498
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05324085
- Acronym / sponsor ID
- SO_CogEx / 171845
- Conditions
- Substance Abuse, Cognitive Dysfunction
- Keywords
- Exercise therapy, High-intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Behavioral: High-intensity interval training, Behavioral: Treatment as usualParticipants will undergo supervised treadmill exercise three times each week for eight weeks, in addition to treatment as usual (TAU). |
| Control group | Other | Behavioral: Treatment as usualParticipants will undergo TAU. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed substance use disorder (SUD) by ICD-10
- Being in residential inpatient treatment for SUD at Lade Addiction Treatment Center
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingAlso: HIITSupervised exercise intervention, three times a week for eight weeks. | Behavioural | Exercise intervention group |
| Treatment as usualThe 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. | Behavioural | Control group, Exercise intervention group |
Primary outcome
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.
12 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: 8 weeks
Change in Stroop test score
Time frame: 8 weeks
Change in Digit Span test performance
Time frame: 8 weeks
Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Time frame: 8 weeks
Altered serum concentration of Klotho
Time frame: 8 weeks
Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)
Time frame: 8 weeks
Altered serum concentration of interleukin 6 (IL6)
Time frame: 8 weeks
Change in maximal cardiorespiratory fitness
Time frame: 8 weeks
Change in mental distress
Time frame: 8 weeks
Change in substance use
Time frame: 8 weeks
Change in substance craving
Time frame: 8 weeks
Change in quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 36570498Haberstroh C, Weider S, Flemmen G, Loe H, Andersson HW, Hallgren M, Mosti MP. The effect of high-intensity interval training on cognitive function in patients with substance use disorder: Study protocol for a two-armed randomized controlled trial. Front Sports Act Living. 2022 Dec 9;4:954561. doi: 10.3389/fspor.2022.954561. eCollection 2022.
- Individual participant dataSharing planned: Undecided. Plan in progress
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats P Mosti, PhD principal investigator
Department of Research and Development, St. Olavs University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Treatment as usual in people with Substance Abuse and Cognitive Dysfunction, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in executive function (EF) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.