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

Sponsor
University of Thessaly (Other)
Overall Status
Completed
CT.gov ID
NCT02664727
Collaborator
European Social Fund (Other)
13
2
5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The effects of acute exercise in heavy drinkers
  • Behavioral: The effects of acute exercise in alcoholic patients
N/A

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 (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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Heavy drinkers

The effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR).

Behavioral: The effects of acute exercise in heavy drinkers
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.

Experimental: Alcoholic patients

The effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax).

Behavioral: The effects of acute exercise in alcoholic patients
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Urge to drink score [Before (0 min) and after exercise trial (30 min)]

    According to questionnaire

  2. Changes in Beta-endorphin levels [Before (0 min) and after exercise trial (30 min)]

    Measured by radioimmunoassay (RIA)

  3. Changes in Cortisol levels [Before (0 min) and after exercise trial (30 min)]

    Measured by radioimmunoassay (RIA)

  4. Changes in Adrenocorticotrophic hormone (ACTH) levels [Before (0 min) and after exercise trial (30 min)]

    Measured by radioimmunoassay (RIA)

  5. Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels [Before (0 min) and after exercise trial (30 min)]

    Measured by radioimmunoassay (RIA)

  6. Changes in C-reactive protein (CRP) levels [Before (0 min) and after exercise trial (30 min)]

    Semi-quantitative estimation with CRP Latex test kit

  7. Changes in Complete blood count values [Before (0 min) and after exercise trial (30 min)]

    Autoanalyzer

  8. Changes in Lactic acid levels [Before (0 min) and after exercise trial (30 min)]

    Measured using photometry

  9. Changes in Erythrocyte sedimentation rate (ESR) values [Before (0 min) and after exercise trial (30 min)]

    Wintrobe Method

  10. Changes in γ-Glutamyltransferase (GGT) levels [Before (0 min) and after exercise trial (30 min)]

    Measured with commercial kit

  11. Changes in Aspartate Aminotransferase (AST) levels [Before (0 min) and after exercise trial (30 min)]

    Measured with commercial kit

  12. Changes in Alanine Aminotransferase (ALT) levels [Before (0 min) and after exercise trial (30 min)]

    Measured with commercial kit

Secondary Outcome Measures

  1. Sit and reach flexibility test for the hamstrings muscles and lower back [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 [Before trial (baseline)]

    Handgrip strength test

  3. Number of push-ups performed in one minute [Before trial (baseline)]

  4. Number of sit-ups performed until exhaustion [Before trial (baseline)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Thessaly
  • European Social Fund

Investigators

  • Study Chair: Yannis Theodorakis, PhD, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Athanasios Z. Jamurtas, Dr, University of Thessaly
ClinicalTrials.gov Identifier:
NCT02664727
Other Study ID Numbers:
  • UThessaly
First Posted:
Jan 27, 2016
Last Update Posted:
Jan 28, 2016
Last Verified:
Jan 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Athanasios Z. Jamurtas, Dr, University of Thessaly
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2016