Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
Primary Purpose
Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise training program
Sponsored by
About this trial
This is an interventional treatment trial for Heavy Drinking focused on measuring Heavy drinking, Heavy drinking cessation, Alcohol abuse, alcohol use disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control condition
Exercise training program
Arm Description
Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.
Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week.
Outcomes
Primary Outcome Measures
Changes in alcohol consumption (grams of alcohol consumed weekly)
Self-recorded
Changes in Beta-endorphin levels
Measured by radioimmunoassay (RIA)
Secondary Outcome Measures
Urge to drink
According to questionnaire
Cortisol
Measured by radioimmunoassay (RIA)
Adrenocorticotrophic hormone (ACTH)
Measured by radioimmunoassay (RIA)
Catecholamines (epinephrine, norepinephrine, dopamine)
Measured by radioimmunoassay (RIA)
C-reactive protein (CRP)
Semi-quantitative estimation with CRP Latex test kit
Complete blood count
Autoanalyzer Autoanalyzer Autoanalyzer
Lactic acid
Measured using photometry
Erythrocyte sedimentation rate (ESR)
Wintrobe Method
γ-Glutamyltransferase (GGT)
Measured with commercial kit
Aspartate Aminotransferase (AST)
Measured with commercial kit
Alanine Aminotransferase (ALT)
Measured with commercial kit
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
NCT02664766
First Posted
January 18, 2016
Last Updated
January 26, 2016
Sponsor
University of Thessaly
Collaborators
European Social Fund
1. Study Identification
Unique Protocol Identification Number
NCT02664766
Brief Title
Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
Official Title
Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
June 2015 (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
No
5. Study Description
Brief 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.
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder
Keywords
Heavy drinking, Heavy drinking cessation, Alcohol abuse, alcohol use disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.
Arm Title
Exercise training program
Arm Type
Experimental
Arm Description
Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in alcohol consumption (grams of alcohol consumed weekly)
Description
Self-recorded
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Changes in Beta-endorphin levels
Description
Measured by radioimmunoassay (RIA)
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Secondary Outcome Measure Information:
Title
Urge to drink
Description
According to questionnaire
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Cortisol
Description
Measured by radioimmunoassay (RIA)
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Adrenocorticotrophic hormone (ACTH)
Description
Measured by radioimmunoassay (RIA)
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Catecholamines (epinephrine, norepinephrine, dopamine)
Description
Measured by radioimmunoassay (RIA)
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
C-reactive protein (CRP)
Description
Semi-quantitative estimation with CRP Latex test kit
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Complete blood count
Description
Autoanalyzer Autoanalyzer Autoanalyzer
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Lactic acid
Description
Measured using photometry
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Erythrocyte sedimentation rate (ESR)
Description
Wintrobe Method
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
γ-Glutamyltransferase (GGT)
Description
Measured with commercial kit
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Aspartate Aminotransferase (AST)
Description
Measured with commercial kit
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Alanine Aminotransferase (ALT)
Description
Measured with commercial kit
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Sit and reach flexibility test for the hamstrings muscles and lower back
Description
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.
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Grip strength
Description
Handgrip strength test
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Number of push-ups performed in one minute
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Title
Number of sit-ups performed until exhaustion
Time Frame
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannis Theodorakis, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
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