The Effect of Exercise on Cognition and Preventing Depression in Young People

NCT04816617 | Completed DMC

• 1 other identifier: Exercise, Cogntion and MDD
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that approximately 30% of child and adolescents manifest subthreshold depression (including other specified depressive disorder and unspecified depressive disorder), which can further develop into major depression with as high as 25%-50% within one year. The cognitive development of adolescents is a critical area of research, given its significant implications for academic performance, mental health, and overall well-being. During adolescence, the brain undergoes substantial structural and functional changes, particularly in regions associated with executive function, memory, and processing speed. These changes provide a unique opportunity to explore interventions that can support and enhance cognitive development. One such promising intervention is physical exercise. Adolescence is characterized by rapid cognitive growth, including improvements in executive functions such as planning, decision-making, and inhibitory control. These cognitive abilities are essential for academic success and social interactions. However, this period also presents risks for cognitive and emotional disturbances, making it vital to identify effective strategies to promote healthy cognitive development. Despite the promising evidence, there is a need for more rigorous research, particularly long-term randomized controlled trials (RCTs), to establish the causal relationship between exercise and cognitive function in adolescents, including those with sub-threshold depression. Most existing studies have focused on short-term interventions or specific cognitive tasks, leaving a gap in our understanding of the sustained effects of exercise over an extended period. Additionally, the transition from supervised to unsupervised exercise and its impact on adherence and cognitive outcomes is underexplored. There is also a need to evaluate the potential of exercise as a preventive strategy against the development of major depressive disorder in this vulnerable population. Additionally, evidence suggests that participants with lower baseline levels of physical activity may experience more significant cognitive improvements from exercise interventions than those with higher baseline activity levels. This highlights the importance of considering baseline physical activity levels when assessing the effectiveness of exercise on cognitive outcomes. This study will particularly focus on the cognitive domains of attention, memory, and processing speed. These domains are critical for academic success and daily functioning and are often impacted in adolescents with sub-threshold depression. Previous research has shown that these domains are particularly responsive to physical exercise interventions.

Conditions

Subthreshold Depression; Exercise; Clinically-well; Cognitive Change

Keywords

Subthreshold depression, aerobic exercise, Major depression, Intervention; Cognition

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Attention measure by Choice Reaction Time task (CRT) incorporated into THINC-it®

  Attention will be measured by the Choice Reaction Time task (CRT).

  month 12

Secondary Outcomes (11)

• The rate of occurrence of MDD

  Month 6 and month 12

• Levels of inflammatory biomarkers from baseline

  Month 6 and month 12

• Occurrence of Non-suicidal self-injury and suicidal behavior

  Month 6 and month 12

• Physical activity level

  Month 6 and 12

• P Wave changes over time

  Month 6 and 12

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.

Behavioral: Aerobic exercise intervention

Psycho-education

PLACEBO COMPARATOR

It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.

Behavioral: Psycho-education

Interventions

Aerobic exercise intervention BEHAVIORAL

The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.

Aerobic Exercise

Psycho-education BEHAVIORAL

It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.

Psycho-education

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• PHQ-9 ≥5
• \~17 years old.

You may not qualify if:

• Current or past DSM-5 criteria for major depressive disorder,Bipolar disorder, Schizophrenia.
• Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising
• A history of organic brain disease or brain trauma
• Alcohol, drug or other psychoactive substance abuse or dependence
• Currently enrolled in another exercise study
• Any conditions that would make exercise unsafe or unwise
• Taking medication that interferes with heart rate response to exercise such as beta blockers

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

The first Huaiji middle school

Shaoxing, Guangdong, China

Location

Related Publications (1)

• Werneck AO, Tian X, Lu W, Li D, Liu T, Wu S, Li X, Wang R, Gao Y, Li X, Chen J, Vancampfort D, Solmi M, Fabiano N, Schuch F, Plener PL, McIntyre RS, So KF, Stubbs B, Lin K. Can exercise reduce the risk of suicidal ideation and behaviors in youth at school? A 12-month cluster randomized control trial. J Psychiatr Res. 2025 Dec 11;194:71-78. doi: 10.1016/j.jpsychires.2025.12.025. Online ahead of print.

  PMID: 41448028 DERIVED

MeSH Terms

Conditions

Motor Activity; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kangguang Lin, MD,PhD

  The Affiliated Brain Hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Tifei Yuan, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

• Kwok-Fai So, PhD

  Jinan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.PhD

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: October 21, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)