Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders

Study Overview
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Brief Summary
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The purpose of this research is to examine the effects of exercise of different intensities on psychological, physiological, biochemical, physiological and alcohol-related parameters in individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse. For that purpose, a control group of individuals that do not exceed the limits for moderate alcohol use will be included.

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 (AUDs), research is limited. The present study investigates whether exercise could be a safe adjunct therapy for alcohol abuse cessation, and the possible mechanisms involved. One of the basic assumptions is that the appropriate form of exercise in individuals with AUDs 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, (current study) 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, 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 Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders

Conditions
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Heavy Drinking, Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: The effects of acute exercise in heavy drinkers
* Behavioral: The effects of acute exercise in alcoholic patients


Participation Criteria
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Eligibility Criteria
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For alcoholics: Inclusion Criteria: Confirmed alcohol addiction according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria in the past, after detoxification phase, lack of dependence on other substances Alcohol Use Disorders Identification Test (AUDIT) score>20 Exclusion Criteria: Medical conditions or medication use that would preclude participation in aerobic exercise For heavy drinkers: 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 National Institute on Alcohol Abuse and Alcoholism (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) AUDIT score>8 Exclusion Criteria: Medical conditions or medication use that would preclude participation in aerobic exercise For healthy controls: 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 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) 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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Accepts Healthy Volunteers

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavy drinkers<br>The effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR). | Behavioral: The effects of acute exercise in heavy drinkers<br>* A group of heavy drinkers and a group of healthy controls (individuals without alcohol use disorders) will cycle on a cycle ergometer for 30 min at 50-60% of HRR. Before and immediately after exercise blood will be drawn and psychological and physiological parameters will be measured.<br>|
| Experimental: Alcoholic patients<br>The effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax). | Behavioral: The effects of acute exercise in alcoholic patients<br>* A group of alcoholic patients (10-14 days after detoxification) and a group of healthy controls (individuals without alcohol use disorders) will cycle on a cycle ergometer for 30 min at 55-60% of HRmax. Before and immediately after exercise blood will be drawn and psychological and physiological parameters will be measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Urge to drink score | According to questionnaire | Before (0 min) and after exercise trial (30 min) | 
| Changes in Beta-endorphin levels | Measured by radioimmunoassay (RIA) | Before (0 min) and after exercise trial (30 min) | 
| Changes in Cortisol levels | Measured by radioimmunoassay (RIA) | Before (0 min) and after exercise trial (30 min) | 
| Changes in Adrenocorticotrophic hormone (ACTH) levels | Measured by radioimmunoassay (RIA) | Before (0 min) and after exercise trial (30 min) | 
| Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels | Measured by radioimmunoassay (RIA) | Before (0 min) and after exercise trial (30 min) | 
| Changes in C-reactive protein (CRP) levels | Semi-quantitative estimation with CRP Latex test kit | Before (0 min) and after exercise trial (30 min) | 
| Changes in Complete blood count values | Autoanalyzer | Before (0 min) and after exercise trial (30 min) | 
| Changes in Lactic acid levels | Measured using photometry | Before (0 min) and after exercise trial (30 min) | 
| Changes in Erythrocyte sedimentation rate (ESR) values | Wintrobe Method | Before (0 min) and after exercise trial (30 min) | 
| Changes in γ-Glutamyltransferase (GGT) levels | Measured with commercial kit | Before (0 min) and after exercise trial (30 min) | 
| Changes in Aspartate Aminotransferase (AST) levels | Measured with commercial kit | Before (0 min) and after exercise trial (30 min) | 
| Changes in Alanine Aminotransferase (ALT) levels | Measured with commercial kit | Before (0 min) and after exercise trial (30 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before trial (baseline) | 
| Grip strength | Handgrip strength test | Before trial (baseline) | 
| Number of push-ups performed in one minute |  | Before trial (baseline) | 
| Number of sit-ups performed until exhaustion |  | Before trial (baseline) | 

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