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Completed

NCT Number: NCT06736067

Effects of a Single-bout of Moderate-intensity Aerobic Exercise on Mood and Mental Health Biomarkers in Adults with Depressive And/or Anxiety Symptoms

This study investigates whether a single session of aerobic exercise (like running) can improve the participants' mood and whether such benefits can be explained by changes in the blood factors (like hormones) and brain activity.

The main questions this study aims to answer are:

* Can a single session of aerobic exercise improve mood? * Which changes in the blood and brain could explain the effects of exercise on mood?

Researchers will compare the participants' mood states before and after exercise to see whether exercise can improve mood.

The participants will:

* Answer questionnaires, collect blood, and undergo magnetic resonance imaging (MRI) before exercise. * Perform 30 minutes of running on a treadmill. * Answer the same questionnaires, collect blood, and undergo magnetic resonance imaging (MRI) after exercise.

The entire assessment will last for about 2h45min and will be performed on a single day.

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Key information

Conditions

Healthy Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Depression Symptoms Mental Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects within the stipulated age range

Exclusion criteria

  • Acute injury or illness that impairs the ability to safely exercise and/or inability to exercise with a moderate intensity;
  • Metabolic and/or neurologic disorders;
  • Iron implants;
  • People who cannot stay still, are intolerant of noise or fearful of enclosed spaces (due to the small space inside the scanner).

Treatment and study plan

Exercise

Behavioral

Thirty minutes of exercise on a treadmill, including a 5-minute warm-up followed by increments in speed until reaching optimal moderate to high intensity (60-80% of age-predicted maximal heart rate), which will be maintained for 20 min, followed by a 5-minute cool-down. Age-predicted maximal HR will be defined as 220 beats-per-minute (BPM) minus age in years.

Primary outcomes

  1. Profile of Mood States (POMS)

    Time frame: From before to immediately after a single session of exercise

    POMS is a 30-item questionnaire scored on a 5-point Likert-type scale ranging from "Not at all" to "Extremely." It provides six sub≥scales: 1) anger (e.g., grouchy, furious); 2) confusion (e.g., muddled, forgetful); 3) depression (e.g., sad, unworthy); 4) fatigue (e.g., tired, sluggish); 5) tension (e.g., nervous, anxious); and 6) vigor (e.g., lively, active).

Secondary outcomes

  1. Subjective Exercise Experience Scale (SEES)

    Time frame: From before to immediately after a single session of exercise

    SEES is a 12-item questionnaire that is scored on a 7-point Likert-type scale ranging from "Not at all" to "Very much". It Provides 3 subscales that will be used in the present study: 1) psychological well-being (great, positive, strong, terrific); 2) psychological distress (awful, crummy, discouraged, miserable); and 3) fatigue (drained, exhausted, fatigued, tired).

  2. Subject Happiness Scale (SHS)

    Time frame: From before to immediately after a single session of exercise

    SHS is a 4-item self-report measure developed to assess an individual's overall happiness as measured through self-evaluation. The response format is a 7-point Likert-type scale.

  3. Blood biomarkers

    Time frame: From before to immediately after a single session of exercise

    Blood biomarkers, including brain-derived neurotrophic factor (BDNF) and Adiponectin

  4. Cardiovascular parameters

    Time frame: Before, during, and immediately after a single session of exercise

    Heart Rate Variability (HRV) will be monitored during all the exercise protocol.

  5. BOLD-weighted fMRI images

    Time frame: From before to immediately after a single session of exercise

    BOLD-weighted fMRI images will be acquired using a gradient-echo echo-planar imaging (GRE-EPI) sequence with (a) repetition time = 2000 ms, (b) echo time = 30 ms, (c) flip angle = 90°, (d) matrix = 64 × 64, (e) field of view = 220 mm × 220 mm, (f) slice thickness = 4 mm with interslice gap = 0.6 mm, and (g) 33 interleaved axial slices. Additionally, weighted images will be acquired with an interleaved sequence (188 sagittal slices, TR/TE/flip angle = 8.2 ms/3.7 ms/7°, matrix = 256 × 256 mm2, FOV = 256 × 256 × 188 mm, and voxel size = 1 × 1 × 1 mm3).

  6. Diffusion-weighted image (DWI)

    Time frame: From before to immediately after a single session of exercise

    Whole-brain diffusion-weighted image (DWI) will be collected with a single-shot diffusion-weighted echo planar imaging sequence (TE, 83 ms; TR, 8700 ms; flip angle, 90°; image resolution, 1.64 mm isotropic; b value, 800 s/mm2; 70 axial slices) in 30 diffusion encoding directions and one non-diffusion-weighted reference image (b = 0).

  7. Magnetic resonance spectroscopy (MRS)

    Time frame: From before to immediately after a single session of exercise

    Magnetic resonance spectroscopy (MRS) will be utilized to measure levels of glutamate and GABA.

Sponsors and collaborators

Lead sponsor

YAU Suk Yu Sonata

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Dec 16, 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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