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

December 12, 2024 updated by: YAU Suk Yu Sonata

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate-intensity aerobic exercise
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From before to immediately after a single session of exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From before to immediately after a single session of exercise
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.
From before to immediately after a single session of exercise
Blood biomarkers
Time Frame: From before to immediately after a single session of exercise
Blood biomarkers, including brain-derived neurotrophic factor (BDNF) and Adiponectin
From before to immediately after a single session of exercise
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.
Before, during, and immediately after a single session of exercise
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).
From before to immediately after a single session of exercise
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).
From before to immediately after a single session of exercise
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.
From before to immediately after a single session of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Actual)

August 24, 2024

Study Completion (Actual)

August 26, 2024

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20221111001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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