NCT06736067

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 5, 2024

Last Update Submit

December 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    From before to immediately after a single session of exercise

Secondary Outcomes (7)

  • Subjective Exercise Experience Scale (SEES)

    From before to immediately after a single session of exercise

  • Subject Happiness Scale (SHS)

    From before to immediately after a single session of exercise

  • Blood biomarkers

    From before to immediately after a single session of exercise

  • Cardiovascular parameters

    Before, during, and immediately after a single session of exercise

  • BOLD-weighted fMRI images

    From before to immediately after a single session of exercise

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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.

Moderate-intensity aerobic exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects within the stipulated age range

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 16, 2024

Study Start

July 18, 2023

Primary Completion

August 24, 2024

Study Completion

August 26, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations