Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

27 de janeiro de 2016 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

13

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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).
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.
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).
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in Urge to drink score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Before (0 min) and after exercise trial (30 min)
Autoanalyzer
Before (0 min) and after exercise trial (30 min)
Changes in Lactic acid levels
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Before (0 min) and after exercise trial (30 min)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sit and reach flexibility test for the hamstrings muscles and lower back
Prazo: 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
Prazo: Before trial (baseline)
Handgrip strength test
Before trial (baseline)
Number of push-ups performed in one minute
Prazo: Before trial (baseline)
Before trial (baseline)
Number of sit-ups performed until exhaustion
Prazo: Before trial (baseline)
Before trial (baseline)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Cadeira de estudo: Yannis Theodorakis, PhD, University of Thessaly

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de março de 2014

Conclusão do estudo (Real)

1 de junho de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

15 de janeiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de janeiro de 2016

Primeira postagem (Estimativa)

27 de janeiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

28 de janeiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de janeiro de 2016

Última verificação

1 de janeiro de 2016

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever