Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

27 januari 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

13

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: 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.
Experimenteel: 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).
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in Urge to drink score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Before (0 min) and after exercise trial (30 min)
Autoanalyzer
Before (0 min) and after exercise trial (30 min)
Changes in Lactic acid levels
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sit and reach flexibility test for the hamstrings muscles and lower back
Tijdsspanne: 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
Tijdsspanne: Before trial (baseline)
Handgrip strength test
Before trial (baseline)
Number of push-ups performed in one minute
Tijdsspanne: Before trial (baseline)
Before trial (baseline)
Number of sit-ups performed until exhaustion
Tijdsspanne: Before trial (baseline)
Before trial (baseline)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Thessaly

Medewerkers

European Social Fund

Onderzoekers

  • Studie stoel: Yannis Theodorakis, PhD, University of Thessaly

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2014

Primaire voltooiing (Werkelijk)

1 maart 2014

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

15 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2016

Eerst geplaatst (Schatting)

27 januari 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

28 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

27 januari 2016

Laatst geverifieerd

1 januari 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UThessaly

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Alcohol afhankelijkheid

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Taiwan

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren