HealthyNCT06736067
Effects of a Single-bout of Moderate-intensity Aerobic Exercise on Mood and Mental Health Biomarkers in Adults with Depressive And/or Anxiety Symptoms
A study testing Exercise in people with Healthy and Depression Symptoms, run by YAU Suk Yu Sonata at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Depression Symptoms, Anxiety Symptoms
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jul 2023to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects within the stipulated age range
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Conditions
- Healthy, Depression Symptoms, Anxiety Symptoms
- Being tested
- Exercise
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS)
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).
Measured: From before to immediately after a single session of exercise
Secondary outcomes (7)
Subjective Exercise Experience Scale (SEES)
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).
Measured: From before to immediately after a single session of exercise
Subject Happiness Scale (SHS)
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.
Measured: From before to immediately after a single session of exercise
Blood biomarkers
Blood biomarkers, including brain-derived neurotrophic factor (BDNF) and Adiponectin
Measured: From before to immediately after a single session of exercise
Cardiovascular parameters
Heart Rate Variability (HRV) will be monitored during all the exercise protocol.
Measured: Before, during, and immediately after a single session of exercise
BOLD-weighted fMRI images
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).
Measured: From before to immediately after a single session of exercise
Diffusion-weighted image (DWI)
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).
Measured: From before to immediately after a single session of exercise
Magnetic resonance spectroscopy (MRS)
Magnetic resonance spectroscopy (MRS) will be utilized to measure levels of glutamate and GABA.
Measured: From before to immediately after a single session of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start18 Jul 2023
- Primary completion24 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- YAU Suk Yu Sonata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YAU Suk Yu Sonata, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736067
- Sponsor's protocol ID
- HSEARS20221111001-01
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single-bout of Moderate-intensity Aerobic Exercise on Mood and Mental Health Biomarkers in Adults with Depressive And/or Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT06736067
- Acronym / sponsor ID
- HSEARS20221111001-01
- Conditions
- Healthy, Depression Symptoms, Anxiety Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- YAU Suk Yu SonataUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | Behavioral: ExerciseThirty 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects within the stipulated age range
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThirty 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. | Behavioural | Moderate-intensity aerobic exercise |
Primary outcome
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).
7 secondary outcomes
Subjective Exercise Experience Scale (SEES)
Time frame: 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
Blood biomarkers
Time frame: From before to immediately after a single session of exercise
Cardiovascular parameters
Time frame: 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
Diffusion-weighted image (DWI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy and Depression Symptoms, run by YAU Suk Yu Sonata at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States (POMS) (time frame: From before to immediately after a single session of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.