Clinical trial NCT02664766: Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
Official title: Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Alcohol Abuse
Alcohol Use Disorder
Keywords: Heavy drinking
Heavy drinking cessation
Alcohol abuse
alcohol use disorder
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: European Social Fund
First posted: 2016-01-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in alcohol consumption (grams of alcohol consumed weekly)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Changes in Beta-endorphin levels
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Secondary outcomes:
measure: Urge to drink
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Cortisol
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Adrenocorticotrophic hormone (ACTH)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Catecholamines (epinephrine, norepinephrine, dopamine)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: C-reactive protein (CRP)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Complete blood count
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Lactic acid
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: γ-Glutamyltransferase (GGT)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Aspartate Aminotransferase (AST)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Alanine Aminotransferase (ALT)
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Sit and reach flexibility test for the hamstrings muscles and lower back
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Grip strength
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Number of push-ups performed in one minute
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
measure: Number of sit-ups performed until exhaustion
timeFrame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Thessaly
name: Yannis Theodorakis, PhD
role: STUDY_CHAIR
References: