Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders
1 other identifier
interventional
13
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedJanuary 28, 2016
January 1, 2016
2 months
January 15, 2016
January 27, 2016
Conditions
Keywords
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
EXPERIMENTALThe effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR).
Alcoholic patients
EXPERIMENTALThe effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax).
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.
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.
Eligibility Criteria
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
- University of Thessalylead
- European Social Fundcollaborator
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.
PMID: 26668589RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yannis Theodorakis, PhD
University of Thessaly
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