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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664766
• Other study ID #: UThessaly 2
• Status: Completed
• Phase: N/A
• First received: January 18, 2016
• Last updated: January 26, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholic Intoxication
• Heavy Drinking

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	European Social Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	?-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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No