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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Heavy Drinking; Alcohol Abuse
• Intervention / Treatment: Behavioral: Exercise training program

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control condition; Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.
Experimental: Exercise training program; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Thessaly
• Collaborators: European Social Fund
• Investigators: Study Chair: Yannis Theodorakis, PhD, University of Thessaly

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Alcohol abuse; alcohol use disorder; Heavy drinking; Heavy drinking cessation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Alcoholic Intoxication
• Other Study ID Numbers: UThessaly 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO