An interventional study of Aerobic Exercise and Agility-Cognitive Exercise in Physical Exercise, sponsored by University of Minho. Not yet recruiting. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Minho · Not applicable, Interventional, and Prevention
The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD.
The proposed research plan focuses on the identification of changes in the structural and functional brain parameters (e.g. volume, brain activity), in response to a physical exercise (PE) protocol, on the neurocircuitry of addiction, after a 4 month-intervention program in college binge drinkers (BDs). The main objectives of this proposal are: O1) to evaluate the potential benefits of PE on the brain structure and function, particularly in the neurocircuitry of addiction, in a sample of Portuguese college students with a binge drinking pattern of alcohol use; and O2) to determine whether the PE intervention reduces craving and alcohol consumption levels in BDs. The present project will involve: i) a pre-intervention comprehensive evaluation of behavioral (alcohol consumption), psychological (craving levels), physiological (VO2, HRV), and neurological (neuroimaging) variables; ii) a training phase consisting of 48 sessions (3 weekly sessions*16 weeks) of aerobic (exp group 1), agility-cognitive (exp group 2) exercise and stretching (control group; iii) a post-intervention evaluation of behavioral, physiological, and neurological (neuroimaging) variables; iv) and a 6 months' follow- up evaluation of behavioral, physiologicaln and cognitive variables. A randomized controlled trial will be implemented at the University of Minho. It will include a total of 60 college students with a binge drinking pattern of alcohol intake, 20 participants per condition.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →University of Minho is the lead sponsor of 39 studies on the registry; 9 are open to participants now.
Compared within Binge Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to the Experimental condition 1 will be following a aerobic exercise training program.
Behavioral: Aerobic Exercise
Participants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program.
Behavioral: Agility-Cognitive Exercise
Participants allocated to the Control condition will be following a stretching/relaxation training program.
Behavioral: Stretching/relaxation
Participants allocated to the Aerobic condition will be following a 4 month-intervention aerobic exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
Participants allocated to the Agility-Cognitive condition will be following a 4 month-intervention agility-cognitive exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
Participants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration
Behavioral: alcohol consumption
Number of drinks per binge drinking episode
Time frame: Through study completion, an average of 1 year
Behavioral: binge episodes
Number of binge drinking episodes
Time frame: Through study completion, an average of 1 year
Behavioral : drunkenness
Percentage of drunkenness
Time frame: Through study completion, an average of 1 year
Psychological (craving levels)
Scores in the Alcohol Craving Questionnaire (The cutoff points for total scale points are: 12-17 = minimal desire, 18-25 = mild, 26-42 = moderate and 43 or more = severe)
Time frame: Through study completion, an average of 1 year
Brain structure
Structure-volume in liters
Time frame: Through study completion, an average of 1 year
Brain structural connectivity- FA
Structural connectivity-fractional anisotropy-scalar value between zero and one within a voxel that describes the degree of anisotropy of a diffusion process
Time frame: Through study completion, an average of 1 year
Brain structural connectivity - MD
Structural connectivity-mean diffusivity-a scalar measure between zero and one that describes the total diffusion within a voxel
Time frame: Through study completion, an average of 1 year
Brain structural connectivity - AD
Structural connectivity-axial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.
Time frame: Through study completion, an average of 1 year
Brain structural connectivity - RD
Structural connectivity-radial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.
Time frame: Through study completion, an average of 1 year
Brain function
Bold signal for Task-related fMRI
Time frame: Through study completion, an average of 1 year
Brain function-resting state
Functional connectivity for resting-state fMRI
Time frame: Through study completion, an average of 1 year
Monetary Incentive Delay Task (included in the fMRI paradigm) - hits
Accuracy, measured through the number of hits to assess the hypothetical differences in participant's level of achievement between the pretest, posttest and follow-up assessments.
Time frame: Through study completion, an average of 1 year
Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time
Reaction times, measured as seconds needed to give a response to assess the hypothetical differences in participant's level of achievement between the pretest, posttest and follow-up assessments.
Time frame: Through study completion, an average of 1 year
Maximal oxygen consumption (VO2max)
VO2max (ml/kg/min) will be measured in the pretest and posttest evaluations to assess the effects of the physical exercise protocol on cardiovascular fitness.
Time frame: Through study completion, an average of 1 year
Brain-derived neurotrophic factor (BDNF)
BDNF (pg/ml) concentrations measured in saliva will be measured in pre-intervention, post-intervention, at the midpoint of the intervention (2 months), and at the follow-up to assess the effects of the physical exercise protocol on neuroplasticity-related molecular markers.
Time frame: Through study completion, an average of 1 year
Dopamine
Dopamine (pg/ml) concentrations measured in urine will be measured in pre-intervention, post-intervention, at the midpoint of the intervention (2 months), and at the follow-up to assess the effects of the physical exercise protocol on reward-related molecular markers.
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Start is estimated for Jan 2026; primary completion for Dec 2027, 23 months later.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Minho