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

27. Januar 2016 aktualisiert von: Athanasios Z. Jamurtas, University of Thessaly

Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

13

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
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).
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in Urge to drink score
Zeitfenster: Before (0 min) and after exercise trial (30 min)
According to questionnaire
Before (0 min) and after exercise trial (30 min)
Changes in Beta-endorphin levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Before (0 min) and after exercise trial (30 min)
Changes in Cortisol levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Before (0 min) and after exercise trial (30 min)
Changes in Adrenocorticotrophic hormone (ACTH) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Before (0 min) and after exercise trial (30 min)
Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Before (0 min) and after exercise trial (30 min)
Changes in C-reactive protein (CRP) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Semi-quantitative estimation with CRP Latex test kit
Before (0 min) and after exercise trial (30 min)
Changes in Complete blood count values
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Autoanalyzer
Before (0 min) and after exercise trial (30 min)
Changes in Lactic acid levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured using photometry
Before (0 min) and after exercise trial (30 min)
Changes in Erythrocyte sedimentation rate (ESR) values
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Wintrobe Method
Before (0 min) and after exercise trial (30 min)
Changes in γ-Glutamyltransferase (GGT) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)
Changes in Aspartate Aminotransferase (AST) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)
Changes in Alanine Aminotransferase (ALT) levels
Zeitfenster: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sit and reach flexibility test for the hamstrings muscles and lower back
Zeitfenster: 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.
Before trial (baseline)
Grip strength
Zeitfenster: Before trial (baseline)
Handgrip strength test
Before trial (baseline)
Number of push-ups performed in one minute
Zeitfenster: Before trial (baseline)
Before trial (baseline)
Number of sit-ups performed until exhaustion
Zeitfenster: Before trial (baseline)
Before trial (baseline)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Ermittler

  • Studienstuhl: Yannis Theodorakis, PhD, University of Thessaly

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2014

Primärer Abschluss (Tatsächlich)

1. März 2014

Studienabschluss (Tatsächlich)

1. Juni 2014

Studienanmeldedaten

Zuerst eingereicht

15. Januar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Januar 2016

Zuerst gepostet (Schätzen)

27. Januar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

28. Januar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Januar 2016

Zuletzt verifiziert

1. Januar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

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