NCT02664727

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 15, 2016

Last Update Submit

January 27, 2016

Conditions

Keywords

alcoholalcohol abusealcohol dependencealcohol use disorderheavy drinkingalcohol abuse cessation

Outcome Measures

Primary Outcomes (12)

  • Changes in Urge to drink score

    According to questionnaire

    Before (0 min) and after exercise trial (30 min)

  • Changes in Beta-endorphin levels

    Measured by radioimmunoassay (RIA)

    Before (0 min) and after exercise trial (30 min)

  • Changes in Cortisol levels

    Measured by radioimmunoassay (RIA)

    Before (0 min) and after exercise trial (30 min)

  • Changes in Adrenocorticotrophic hormone (ACTH) levels

    Measured by radioimmunoassay (RIA)

    Before (0 min) and after exercise trial (30 min)

  • Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels

    Measured by radioimmunoassay (RIA)

    Before (0 min) and after exercise trial (30 min)

  • Changes in C-reactive protein (CRP) levels

    Semi-quantitative estimation with CRP Latex test kit

    Before (0 min) and after exercise trial (30 min)

  • Changes in Complete blood count values

    Autoanalyzer

    Before (0 min) and after exercise trial (30 min)

  • Changes in Lactic acid levels

    Measured using photometry

    Before (0 min) and after exercise trial (30 min)

  • Changes in Erythrocyte sedimentation rate (ESR) values

    Wintrobe Method

    Before (0 min) and after exercise trial (30 min)

  • Changes in γ-Glutamyltransferase (GGT) levels

    Measured with commercial kit

    Before (0 min) and after exercise trial (30 min)

  • Changes in Aspartate Aminotransferase (AST) levels

    Measured with commercial kit

    Before (0 min) and after exercise trial (30 min)

  • Changes in Alanine Aminotransferase (ALT) levels

    Measured with commercial kit

    Before (0 min) and after exercise trial (30 min)

Secondary Outcomes (4)

  • Sit and reach flexibility test for the hamstrings muscles and lower back

    Before trial (baseline)

  • Grip strength

    Before trial (baseline)

  • Number of push-ups performed in one minute

    Before trial (baseline)

  • Number of sit-ups performed until exhaustion

    Before trial (baseline)

Study Arms (2)

Heavy drinkers

EXPERIMENTAL

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

Behavioral: The effects of acute exercise in heavy drinkers

Alcoholic patients

EXPERIMENTAL

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

Behavioral: The effects of acute exercise in alcoholic patients

Interventions

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.

Heavy drinkers

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.

Alcoholic patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Medical conditions or medication use that would preclude participation in aerobic exercise
  • For heavy drinkers:
  • 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
  • Medical conditions or medication use that would preclude participation in aerobic exercise
  • For healthy controls:
  • 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
  • Medical conditions or medication use that would preclude participation in aerobic exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.3892/etm.2015.2792. Epub 2015 Oct 13.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yannis Theodorakis, PhD

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 27, 2016

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share