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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
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 18, 2016
    Last Updated
    January 26, 2016
    Sponsor
    University of Thessaly
    Collaborators
    European Social Fund
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    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

    Learn more about this trial

    Effects of Long-term Exercise on Various Parameters in Heavy Drinkers

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