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

Alcohol Use Disorder Clinical Trial

Official title:

Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664727
• Other study ID #: UThessaly
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 27, 2016
• Start date: January 2014
• Est. completion date: June 2014

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 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Heavy Drinking

Intervention

Behavioral:
• The effects of acute exercise in heavy drinkers
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.
• The effects of acute exercise in alcoholic patients
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	European Social Fund

References & Publications (1)

Georgakouli K, Manthou E, Fatouros IG, Deli CK, Spandidos DA, Tsatsakis AM, Kouretas D, Koutedakis Y, Theodorakis Y, Jamurtas AZ. Effects of acute exercise on liver function and blood redox status in heavy drinkers. Exp Ther Med. 2015 Dec;10(6):2015-2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Urge to drink score	According to questionnaire	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Beta-endorphin levels	Measured by radioimmunoassay (RIA)	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Cortisol levels	Measured by radioimmunoassay (RIA)	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Adrenocorticotrophic hormone (ACTH) levels	Measured by radioimmunoassay (RIA)	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels	Measured by radioimmunoassay (RIA)	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in C-reactive protein (CRP) levels	Semi-quantitative estimation with CRP Latex test kit	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Complete blood count values	Autoanalyzer	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Lactic acid levels	Measured using photometry	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Erythrocyte sedimentation rate (ESR) values	Wintrobe Method	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in ?-Glutamyltransferase (GGT) levels	Measured with commercial kit	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Aspartate Aminotransferase (AST) levels	Measured with commercial kit	Before (0 min) and after exercise trial (30 min)	No
Primary	Changes in Alanine Aminotransferase (ALT) levels	Measured with commercial kit	Before (0 min) and after exercise trial (30 min)	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.	Before trial (baseline)	No
Secondary	Grip strength	Handgrip strength test	Before trial (baseline)	No
Secondary	Number of push-ups performed in one minute		Before trial (baseline)	No
Secondary	Number of sit-ups performed until exhaustion		Before trial (baseline)	No