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Completed

NCT Number: NCT02664766

Effects of Long-term Exercise on Various 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.

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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, 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise training program

Behavioral

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 outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • European Social Fund

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 27, 2016
Registry last updated
Jan 27, 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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