Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
27 de enero de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
13
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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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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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).
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Urge to drink score
Periodo de tiempo: 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
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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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
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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Measured by radioimmunoassay (RIA)
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Before (0 min) and after exercise trial (30 min)
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Changes in Adrenocorticotrophic hormone (ACTH) levels
Periodo de tiempo: 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 Catecholamines (epinephrine, norepinephrine, dopamine) levels
Periodo de tiempo: 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 C-reactive protein (CRP) levels
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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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
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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Autoanalyzer
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Before (0 min) and after exercise trial (30 min)
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Changes in Lactic acid levels
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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Measured using photometry
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Before (0 min) and after exercise trial (30 min)
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Changes in Erythrocyte sedimentation rate (ESR) values
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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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
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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Measured with commercial kit
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Before (0 min) and after exercise trial (30 min)
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Changes in Aspartate Aminotransferase (AST) levels
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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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
Periodo de tiempo: Before (0 min) and after exercise trial (30 min)
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Measured with commercial kit
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Before (0 min) and after exercise trial (30 min)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sit and reach flexibility test for the hamstrings muscles and lower back
Periodo de tiempo: 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
Periodo de tiempo: Before trial (baseline)
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Handgrip strength test
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Before trial (baseline)
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Number of push-ups performed in one minute
Periodo de tiempo: Before trial (baseline)
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Before trial (baseline)
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Number of sit-ups performed until exhaustion
Periodo de tiempo: Before trial (baseline)
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Before trial (baseline)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Yannis Theodorakis, PhD, University of Thessaly
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2014
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2016
Publicado por primera vez (Estimar)
27 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de enero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
27 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UThessaly
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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