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

January 26, 2016 updated by: Athanasios Z. Jamurtas, University of Thessaly

Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control condition
Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.
Experimental: Exercise training program
Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week.
Behavioral: Exercise training program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in alcohol consumption (grams of alcohol consumed weekly)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Self-recorded
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Changes in Beta-endorphin levels
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured by radioimmunoassay (RIA)
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urge to drink
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
According to questionnaire
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Cortisol
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured by radioimmunoassay (RIA)
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Adrenocorticotrophic hormone (ACTH)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured by radioimmunoassay (RIA)
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Catecholamines (epinephrine, norepinephrine, dopamine)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured by radioimmunoassay (RIA)
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
C-reactive protein (CRP)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Semi-quantitative estimation with CRP Latex test kit
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Complete blood count
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Autoanalyzer Autoanalyzer Autoanalyzer
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Lactic acid
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured using photometry
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Erythrocyte sedimentation rate (ESR)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Wintrobe Method
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
γ-Glutamyltransferase (GGT)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured with commercial kit
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Aspartate Aminotransferase (AST)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured with commercial kit
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Alanine Aminotransferase (ALT)
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured with commercial kit
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Sit and reach flexibility test for the hamstrings muscles and lower back
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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.
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Grip strength
Time Frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Handgrip strength test
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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
At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Social Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yannis Theodorakis, PhD, University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UThessaly 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings