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Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder (SO_CogEx)

Primary Purpose

Substance Abuse, Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High-intensity interval training
Treatment as usual
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Exercise therapy, High-intensity interval training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lade Behandlingssenter, BlåkorsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2022
Last Updated
May 3, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors
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1. Study Identification

Unique Protocol Identification Number
NCT05324085
Brief Title
Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder
Acronym
SO_CogEx
Official Title
Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Cognitive Dysfunction
Keywords
Exercise therapy, High-intensity interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise intervention group
Arm Type
Experimental
Arm Description
Participants will undergo supervised treadmill exercise three times each week for eight weeks, in addition to treatment as usual (TAU).
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Other Intervention Name(s)
HIIT
Intervention Description
Supervised exercise intervention, three times a week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in executive function (EF)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Montreal Cognitive Assessment (MoCA) score
Description
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.
Time Frame
8 weeks
Title
Change in Stroop test score
Description
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.
Time Frame
8 weeks
Title
Change in Digit Span test performance
Description
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.
Time Frame
8 weeks
Title
Altered serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Description
BDNF is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Time Frame
8 weeks
Title
Altered serum concentration of Klotho
Description
Klotho is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Time Frame
8 weeks
Title
Altered serum concentration of glycosylphosphatidylinositol-specific phospholipase D1 (Gpld1)
Description
Gpld1 is a biochemical marker of neurocognitive/neuroprotective mechanisms that can be measured in human serum
Time Frame
8 weeks
Title
Altered serum concentration of interleukin 6 (IL6)
Description
IL6 is a muscle-secreted protein known to affect neurocognitive/neuroprotective mechanisms
Time Frame
8 weeks
Title
Change in maximal cardiorespiratory fitness
Description
Maximal cardiorespiratory fitness will be measured as oxygen uptake by cardiopulmonary exercise testing on a treadmill, by inclined walking or running on a treadmill
Time Frame
8 weeks
Title
Change in mental distress
Description
Alterations in mental distress will be assessed using the validated brief questionnaire Symptom Checklist-10 (SCL-10)
Time Frame
8 weeks
Title
Change in substance use
Description
Change in substance use will be assessed using a simple self-report questionnaire
Time Frame
8 weeks
Title
Change in substance craving
Description
Change in substance use will be assessed using a simple Visual Analogue Scale ranging from 0 (no craving) to 10 (severe craving)
Time Frame
8 weeks
Title
Change in quality of life
Description
Quality of life will be assessed with a brief version of the World Health Organization Quality of Life assessment
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mats P Mosti, PhD
Phone
+4790193357
Email
Mats.Peder.Mosti@stolav.no
First Name & Middle Initial & Last Name or Official Title & Degree
Carolin Haberstroh, MS
Phone
+4748680392
Email
Carolin.Haberstroh@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats P Mosti, PhD
Organizational Affiliation
Department of Research and Development, St. Olavs University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lade Behandlingssenter, Blåkors
City
Trondheim
State/Province
Trøndelag
ZIP/Postal Code
7041
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragnhild Slettemoen, MS
Email
Ragnhild.Slettemoen@blakors.no
First Name & Middle Initial & Last Name & Degree
Frode Kavli
Email
frode.kavli@ladebs.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan in progress

Learn more about this trial

Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder

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