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
Studieoversigt
Status
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Yannis Theodorakis, PhD, University of Thessaly
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UThessaly
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .