- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02664727
Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in Urge to drink score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Before (0 min) and after exercise trial (30 min)
|
Autoanalyzer
|
Before (0 min) and after exercise trial (30 min)
|
Changes in Lactic acid levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Before (0 min) and after exercise trial (30 min)
|
Measured with commercial kit
|
Before (0 min) and after exercise trial (30 min)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Sit and reach flexibility test for the hamstrings muscles and lower back
Délai: 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
Délai: Before trial (baseline)
|
Handgrip strength test
|
Before trial (baseline)
|
Number of push-ups performed in one minute
Délai: Before trial (baseline)
|
Before trial (baseline)
|
|
Number of sit-ups performed until exhaustion
Délai: Before trial (baseline)
|
Before trial (baseline)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Yannis Theodorakis, PhD, University of Thessaly
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UThessaly
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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