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Completed

NCT Number: NCT04816617

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

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first Huaiji middle school

Shaoxing, Guangdong, China

About this study

This is multi-center, psycho-education randomized controlled trial, consisting of two periods with each of 6 months (i.e supervised and maintenance period). In the exercise intervention arm, during the first 6 months, participants will be asked to do moderate-intensity aerobic exercise 3-4 times a week, which will be supervised in person by physical educators/professionals. In the next 6-month maintenance period, participants will be asked to continue doing aerobic exercise at the same intensity and frequency, which will not be supervised in person by educators/professionals, but they will be sent reminders and report adherence monthly. All of the physical activity will be recorded by accelerometer at scheduled time points (e.g. the first week, 6 week, 3 month, 6 month, 9 month, 12 month). Psycho-education group will be given 6 sections of general psycho-education onsite and/or virtually dependent on the surroundings with regards to the impact of the COVID-19 pandemic. The main aim of this trial is to investigate the effect of long-term aerobic exercise on cognition and prevention depression in young people with or without subthreshold depression.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PHQ-9 ≥5
  • 12~17 years old.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: month 12

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

Secondary outcomes

  1. The rate of occurrence of MDD

    Time frame: Month 6 and month 12

    Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)

  2. Levels of inflammatory biomarkers from baseline

    Time frame: Month 6 and month 12

    inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA

  3. Occurrence of Non-suicidal self-injury and suicidal behavior

    Time frame: Month 6 and month 12

  4. Physical activity level

    Time frame: Month 6 and 12

    The International Physical Activity Questionnaire - Short Form (IPAQ - SF) will be used to assess physical activity level

  5. P Wave changes over time

    Time frame: Month 6 and 12

    Brain activity will be detected by Electroencephalograph (EEG)

  6. New onset of subthreshold depression in healthy volunteers

    Time frame: Month 6 and 12

    subthreshold depression is defined by DSM-5 Other specified Depressive Disorder and Unspecified Depressive Disorder

  7. Changes from baseline in memory measured N-back memory task (N-BACK)

    Time frame: month 6 and month 12

    N-back memory task (N-BACK) was used to measure short-term memory.

  8. Changes from baseline in subjective cognition measured by Perceived Deficits Questionnaire 5 (PDQ-5)

    Time frame: Month 6 and 12

    Perceived Deficits Questionnaire 5 (PDQ-5) is a subjective measure, which broadly evaluates attention/concentration, planning/organisation, as well as retrospective and prospective memory.

  9. Changes from baseline in Processing Speed.

    Time frame: Month 6 and 12

    Digit Symbol Substitution Test (DSST) was used to measure Processing Speed.

  10. Changes from baseline in executive function.

    Time frame: Month 6 and 12

    Trail Making Test-B (TMT-B) was used to measure Executive function.

  11. Changes from baseline in Attention measure by Choice Reaction Time task (CRT)

    Time frame: month 6

    Attention measure by Choice Reaction Time task (CRT)

Sponsors and collaborators

Lead sponsor

Guangzhou Psychiatric Hospital

Other Gov

Collaborators

  • Shanghai Mental Health Center

Registry information

Official study title

A 12-month,Parallel-group, Randomised Controlled Exercise Trial in Young People With and Without Subthreshold Depression

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2021
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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