- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Bayero University Kano, NigeriaCompletedChronic Low Back PainNigeria
-
University College CorkRecruitingDepressive Disorder, MajorIreland