Effects of Long-term Exercise on Various Parameters in Heavy Drinkers

Study Overview
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Brief Summary
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The purpose of this research is to examine the effects of long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse.

Detailed Description
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The mechanism of incentives that lead people to unhealthy habits such as excessive alcohol consumption is not only social, personal, and psychological, but also associated with neurochemical and neurobiological mechanisms. Several programs have been developed to stop excessive drinking, but the success rates are small, while the relapse rates are very high, reaching up to 90%. Although there is some evidence for the beneficial effects of exercise on alcohol use disorders, research is limited. The present study investigates whether exercise can act as adjunct therapy for alcohol abuse cessation. One of the basic assumptions is that the appropriate form of exercise in alcoholics will contribute to the secretion of beta-endorphin, which in combination with psychological pleasure, vitality, change of mood, reduced stress, increased confidence, and the shift of attention will help people to follow healthy lifestyles and abhor alcohol. The research project is divided in three phases. In the first phase, the effect of acute exercise in critical psychological, physiological, biochemical and alcohol-related parameters associated with excessive alcohol consumption will be examined. In the second phase (current study), a long-term exercise program in conjunction with psychological support strategies aimed at alcohol abuse cessation will be developed, implemented and evaluated. Finally, in the third phase, based on the results of the previous phases, awareness programs in adolescent and adult populations will be designed and implemented as well as the dissemination of results and evaluation of the project will take place.

Official Title
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Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers

Conditions
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Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Exercise training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men drinking >14 drinks/week or >4 drinks/occasion; Women drinking >7 drinks/week or >4 drinks/occasion (1 drink = 14 grams of pure alcohol; definition of the NIAAA for drinking at low risk for developing an AUD; NIAAA, 2014) Individuals drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days (1 drink = 14 grams of pure alcohol; definition of the Substance Abuse and Mental Health Services Administration for heavy drinking; NIAAA, 2014) Alcohol Use Disorders Identification Test (AUDIT) score>8 Exclusion Criteria: Medical conditions or medication use that would preclude participation in aerobic exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control condition<br>Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period. | |
| Experimental: Exercise training program<br>Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. | Behavioral: Exercise training program<br>* Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Participants will be recording their daily alcohol consumption. Participants will also undergo three trials of acute exercise (before, at the 4th week and at the 8th week of exercise training) in order to investigate whether exercise training can lead to changes in acute responses to exercise. Each trial involves 30 min of exercise on a cycle ergometer at 50-60% HRR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in alcohol consumption (grams of alcohol consumed weekly) | Self-recorded | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Changes in Beta-endorphin levels | Measured by radioimmunoassay (RIA) | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urge to drink | According to questionnaire | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Cortisol | Measured by radioimmunoassay (RIA) | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Adrenocorticotrophic hormone (ACTH) | Measured by radioimmunoassay (RIA) | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Catecholamines (epinephrine, norepinephrine, dopamine) | Measured by radioimmunoassay (RIA) | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| C-reactive protein (CRP) | Semi-quantitative estimation with CRP Latex test kit | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Complete blood count | Autoanalyzer Autoanalyzer Autoanalyzer | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Lactic acid | Measured using photometry | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Erythrocyte sedimentation rate (ESR) | Wintrobe Method | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| γ-Glutamyltransferase (GGT) | Measured with commercial kit | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Aspartate Aminotransferase (AST) | Measured with commercial kit | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Alanine Aminotransferase (ALT) | Measured with commercial kit | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Sit and reach flexibility test for the hamstrings muscles and lower back | Each participant sits on the floor with legs stretched out straight ahead, reaches out and holds that position for at 1-2 seconds while the distance is recorded. | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Grip strength | Handgrip strength test | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Number of push-ups performed in one minute |  | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 
| Number of sit-ups performed until exhaustion |  | At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heavy drinking, Heavy drinking cessation, Alcohol abuse, alcohol use disorder