Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
27 gennaio 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
13
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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).
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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.
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Sperimentale: 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).
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in Urge to drink score
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
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According to questionnaire
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Before (0 min) and after exercise trial (30 min)
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Changes in Beta-endorphin levels
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Measured by radioimmunoassay (RIA)
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Before (0 min) and after exercise trial (30 min)
|
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Changes in Cortisol levels
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Measured by radioimmunoassay (RIA)
|
Before (0 min) and after exercise trial (30 min)
|
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Changes in Adrenocorticotrophic hormone (ACTH) levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Semi-quantitative estimation with CRP Latex test kit
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Before (0 min) and after exercise trial (30 min)
|
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Changes in Complete blood count values
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Autoanalyzer
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Before (0 min) and after exercise trial (30 min)
|
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Changes in Lactic acid levels
Lasso di tempo: 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
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Wintrobe Method
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Before (0 min) and after exercise trial (30 min)
|
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Changes in γ-Glutamyltransferase (GGT) levels
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Measured with commercial kit
|
Before (0 min) and after exercise trial (30 min)
|
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Changes in Aspartate Aminotransferase (AST) levels
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Measured with commercial kit
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Before (0 min) and after exercise trial (30 min)
|
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Changes in Alanine Aminotransferase (ALT) levels
Lasso di tempo: Before (0 min) and after exercise trial (30 min)
|
Measured with commercial kit
|
Before (0 min) and after exercise trial (30 min)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sit and reach flexibility test for the hamstrings muscles and lower back
Lasso di tempo: 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.
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Before trial (baseline)
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Grip strength
Lasso di tempo: Before trial (baseline)
|
Handgrip strength test
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Before trial (baseline)
|
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Number of push-ups performed in one minute
Lasso di tempo: Before trial (baseline)
|
Before trial (baseline)
|
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Number of sit-ups performed until exhaustion
Lasso di tempo: Before trial (baseline)
|
Before trial (baseline)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Yannis Theodorakis, PhD, University of Thessaly
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2014
Completamento primario (Effettivo)
1 marzo 2014
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
15 gennaio 2016
Primo inviato che soddisfa i criteri di controllo qualità
26 gennaio 2016
Primo Inserito (Stima)
27 gennaio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 gennaio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 gennaio 2016
Ultimo verificato
1 gennaio 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UThessaly
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .