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Completed

NCT Number: NCT02664727

Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 (AUDs), research is limited. The present study investigates whether exercise could be a safe adjunct therapy for alcohol abuse cessation, and the possible mechanisms involved.

One of the basic assumptions is that the appropriate form of exercise in individuals with AUDs 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, (current study) 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, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For alcoholics:

Inclusion criteria

  • 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

Exclusion criteria

  • Medical conditions or medication use that would preclude participation in aerobic exercise

For heavy drinkers:

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 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

Exclusion criteria

  • Medical conditions or medication use that would preclude participation in aerobic exercise

For healthy controls:

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 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

Exclusion criteria

  • Medical conditions or medication use that would preclude participation in aerobic exercise

Treatment and study plan

The effects of acute exercise in heavy drinkers

Behavioral

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.

The effects of acute exercise in alcoholic patients

Behavioral

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.

Primary outcomes

  1. Changes in Urge to drink score

    Time frame: Before (0 min) and after exercise trial (30 min)

    According to questionnaire

  2. Changes in Beta-endorphin levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured by radioimmunoassay (RIA)

  3. Changes in Cortisol levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured by radioimmunoassay (RIA)

  4. Changes in Adrenocorticotrophic hormone (ACTH) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured by radioimmunoassay (RIA)

  5. Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured by radioimmunoassay (RIA)

  6. Changes in C-reactive protein (CRP) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Semi-quantitative estimation with CRP Latex test kit

  7. Changes in Complete blood count values

    Time frame: Before (0 min) and after exercise trial (30 min)

    Autoanalyzer

  8. Changes in Lactic acid levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured using photometry

  9. Changes in Erythrocyte sedimentation rate (ESR) values

    Time frame: Before (0 min) and after exercise trial (30 min)

    Wintrobe Method

  10. Changes in γ-Glutamyltransferase (GGT) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured with commercial kit

  11. Changes in Aspartate Aminotransferase (AST) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured with commercial kit

  12. Changes in Alanine Aminotransferase (ALT) levels

    Time frame: Before (0 min) and after exercise trial (30 min)

    Measured with commercial kit

Secondary outcomes

  1. Sit and reach flexibility test for the hamstrings muscles and lower back

    Time frame: Before trial (baseline)

    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.

  2. Grip strength

    Time frame: Before trial (baseline)

    Handgrip strength test

  3. Number of push-ups performed in one minute

    Time frame: Before trial (baseline)

  4. Number of sit-ups performed until exhaustion

    Time frame: Before trial (baseline)

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • European Social Fund

Registry information

Official study title

Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2016
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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