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

27. januar 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Atferdsmessig: 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.
Eksperimentell: 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).
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Urge to drink score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Before (0 min) and after exercise trial (30 min)
Autoanalyzer
Before (0 min) and after exercise trial (30 min)
Changes in Lactic acid levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Thessaly

Samarbeidspartnere

European Social Fund

Etterforskere

  • Studiestol: Yannis Theodorakis, PhD, University of Thessaly

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Faktiske)

1. mars 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

15. januar 2016

Først innsendt som oppfylte QC-kriteriene

26. januar 2016

Først lagt ut (Anslag)

27. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. januar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. januar 2016

Sist bekreftet

1. januar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UThessaly

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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