Clinical trial NCT05324085: Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder
Official title: Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Cognitive Dysfunction
Keywords: Exercise therapy
High-intensity interval training
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Lade Behandlingssenter, Blå Kors
First posted: 2022-04-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in executive function (EF)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: 8 weeks
measure: Change in Stroop test score
timeFrame: 8 weeks
measure: Change in Digit Span test performance
timeFrame: 8 weeks
measure: Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 8 weeks
measure: Altered serum concentration of Klotho
timeFrame: 8 weeks
measure: Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)
timeFrame: 8 weeks
measure: Altered serum concentration of interleukin 6 (IL6)
timeFrame: 8 weeks
measure: Change in maximal cardiorespiratory fitness
timeFrame: 8 weeks
measure: Change in mental distress
timeFrame: 8 weeks
measure: Change in substance use
timeFrame: 8 weeks
measure: Change in substance craving
timeFrame: 8 weeks
measure: Change in quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Lade Behandlingssenter, Blåkors
state: Trøndelag
Study officials:
affiliation: Department of Research and Development, St. Olavs University Hospital
name: Mats P Mosti, PhD
role: PRINCIPAL_INVESTIGATOR
References: