Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder

Substance Abuse Clinical Trial

— SO_CogEx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324085
• Other study ID #: 171845
• Secondary ID: 3253020430
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: Mats P Mosti, PhD
• Phone: +4790193357
• Email: Mats.Peder.Mosti[@]stolav.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• High-intensity interval training
Supervised exercise intervention, three times a week for eight weeks.
• Treatment 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.

Locations

Country	Name	City	State
Norway	Lade Behandlingssenter, Blåkors	Trondheim	Trøndelag

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Lade Behandlingssenter, Blå Kors, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks
Secondary	Altered serum concentration of Klotho	Klotho is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum	8 weeks
Secondary	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	8 weeks
Secondary	Altered serum concentration of interleukin 6 (IL6)	IL6 is a muscle-secreted protein known to affect neurocognitive/neuroprotective mechanisms	8 weeks
Secondary	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	8 weeks
Secondary	Change in mental distress	Alterations in mental distress will be assessed using the validated brief questionnaire Symptom Checklist-10 (SCL-10)	8 weeks
Secondary	Change in substance use	Change in substance use will be assessed using a simple self-report questionnaire	8 weeks
Secondary	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)	8 weeks
Secondary	Change in quality of life	Quality of life will be assessed with a brief version of the World Health Organization Quality of Life assessment	8 weeks