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

Primary Purpose

Heavy Drinking, Alcohol Abuse, Alcohol Dependence

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

The effects of acute exercise in heavy drinkers

The effects of acute exercise in alcoholic patients

About this trial

This is an interventional treatment trial for Heavy Drinking focused on measuring alcohol, alcohol abuse, alcohol dependence, alcohol use disorder, heavy drinking, alcohol abuse cessation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Heavy drinkers

Alcoholic patients

Arm Description

The effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR).

The effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax).

Outcomes

Primary Outcome Measures

Changes in Urge to drink score

According to questionnaire

Changes in Beta-endorphin levels

Measured by radioimmunoassay (RIA)

Changes in Cortisol levels

Measured by radioimmunoassay (RIA)

Changes in Adrenocorticotrophic hormone (ACTH) levels

Measured by radioimmunoassay (RIA)

Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels

Measured by radioimmunoassay (RIA)

Changes in C-reactive protein (CRP) levels

Semi-quantitative estimation with CRP Latex test kit

Changes in Complete blood count values

Autoanalyzer

Changes in Lactic acid levels

Measured using photometry

Changes in Erythrocyte sedimentation rate (ESR) values

Wintrobe Method

Changes in γ-Glutamyltransferase (GGT) levels

Measured with commercial kit

Changes in Aspartate Aminotransferase (AST) levels

Measured with commercial kit

Changes in Alanine Aminotransferase (ALT) levels

Measured with commercial kit

Secondary Outcome Measures

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.

Grip strength

Handgrip strength test

Number of push-ups performed in one minute

Number of sit-ups performed until exhaustion

Full Information

NCT ID

NCT02664727

First Posted

January 15, 2016

Last Updated

January 27, 2016

Sponsor

University of Thessaly

Collaborators

European Social Fund

1. Study Identification

Unique Protocol Identification Number

NCT02664727

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Thessaly

Collaborators

European Social Fund

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

alcohol, alcohol abuse, alcohol dependence, alcohol use disorder, heavy drinking, alcohol abuse cessation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heavy drinkers

Arm Type

Experimental

Arm Description

The effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR).

Arm Title

Alcoholic patients

Arm Type

Experimental

Arm Description

The effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax).

Intervention Type

Behavioral

Intervention Name(s)

The effects of acute exercise in heavy drinkers

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

The effects of acute exercise in alcoholic patients

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Urge to drink score

Description

According to questionnaire

Time Frame