NCT05324085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

April 4, 2022

Last Update Submit

June 5, 2025

Conditions

Keywords

Exercise therapyHigh-intensity interval training

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (12)

  • Change in Montreal Cognitive Assessment (MoCA) score

    8 weeks

  • Change in Stroop test score

    8 weeks

  • Change in Digit Span test performance

    8 weeks

  • Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)

    8 weeks

  • Altered serum concentration of Klotho

    8 weeks

  • +7 more secondary outcomes

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

Participants will undergo supervised treadmill exercise three times each week for eight weeks, in addition to treatment as usual (TAU).

Behavioral: High-intensity interval trainingBehavioral: 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.

Behavioral: Treatment as usual

Interventions

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

Also known as: HIIT
Exercise intervention group

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.

Control groupExercise intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lade Behandlingssenter, Blåkors

Trondheim, Trøndelag, 7041, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersCognitive Dysfunction

Interventions

High-Intensity Interval TrainingTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mats P Mosti, PhD

    Department of Research and Development, St. Olavs University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

April 7, 2022

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations