Heavy DrinkingNCT02664727
Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
A study testing The effects of acute exercise in heavy drinkers and The effects of acute exercise in alcoholic patients in people with Heavy Drinking and Alcohol Abuse, run by University of Thessaly.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking, Alcohol Abuse, Alcohol Dependence
- What is being tested?
- The effects of acute exercise in heavy drinkers and The effects of acute exercise in alcoholic patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
- 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
Who cannot join
- Medical conditions or medication use that would preclude participation in aerobic exercise
- For heavy drinkers:
- Medical conditions or medication use that would preclude participation in aerobic exercise
- For healthy controls:
- Medical conditions or medication use that would preclude participation in aerobic exercise
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- The effects of acute exercise in heavy drinkers, The effects of acute exercise in alcoholic patients
- Keywords
- alcohol, alcohol abuse, alcohol dependence, alcohol use disorder, heavy drinking, alcohol abuse cessation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effects of acute exercise in heavy drinkersBehavioural
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.
The effects of acute exercise in alcoholic patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Heavy drinkers | Experimental | The effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR). Receives: Behavioral: The effects of acute exercise in heavy drinkers |
| Alcoholic patients | Experimental | The effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax). Receives: Behavioral: The effects of acute exercise in alcoholic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Urge to drink score
According to questionnaire
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Beta-endorphin levels
Measured by radioimmunoassay (RIA)
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Cortisol levels
Measured by radioimmunoassay (RIA)
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Adrenocorticotrophic hormone (ACTH) levels
Measured by radioimmunoassay (RIA)
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels
Measured by radioimmunoassay (RIA)
Measured: Before (0 min) and after exercise trial (30 min)
Changes in C-reactive protein (CRP) levels
Semi-quantitative estimation with CRP Latex test kit
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Complete blood count values
Autoanalyzer
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Lactic acid levels
Measured using photometry
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Erythrocyte sedimentation rate (ESR) values
Wintrobe Method
Measured: Before (0 min) and after exercise trial (30 min)
Changes in γ-Glutamyltransferase (GGT) levels
Measured with commercial kit
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Aspartate Aminotransferase (AST) levels
Measured with commercial kit
Measured: Before (0 min) and after exercise trial (30 min)
Changes in Alanine Aminotransferase (ALT) levels
Measured with commercial kit
Measured: Before (0 min) and after exercise trial (30 min)
Secondary outcomes (4)
Sit and reach flexibility test for the hamstrings muscles and lower back
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.
Measured: Before trial (baseline)
Grip strength
Handgrip strength test
Measured: Before trial (baseline)
Number of push-ups performed in one minute
Measured: Before trial (baseline)
Number of sit-ups performed until exhaustion
Measured: Before trial (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- European Social Fund
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Yannis Theodorakis, PhD, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664727
- Sponsor's protocol ID
- UThessaly
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Georgakouli K, Manthou E, Fatouros IG, Deli CK, Spandidos DA, Tsatsakis AM, Kouretas D, Koutedakis Y, Theodorakis Y, Jamurtas AZ. Effects of acute exercise on liver function and blood redox status in heavy drinkers. Exp Ther Med. 2015 Dec;10(6):2015-2022. doi: 10.3892/etm.2015.2792. Epub 2015 Oct 13.
PubMed 26668589
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT02664727
- Acronym / sponsor ID
- UThessaly
- Keywords
- alcohol, alcohol abuse, alcohol dependence, alcohol use disorder, heavy drinking, alcohol abuse cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- European Social Fund
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy drinkers | Experimental | Behavioral: The effects of acute exercise in heavy drinkersThe effects of acute exercise in heavy drinkers. Participants will cycle on ergometer for 30 min at 50-60% of Heart Rate Reserve (HRR). |
| Alcoholic patients | Experimental | Behavioral: The effects of acute exercise in alcoholic patientsThe effects of acute exercise in alcoholic patients. Participants will cycle on ergometer for 30 min at 55-60% of Heart Rate maximal (HRmax). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- Medical conditions or medication use that would preclude participation in aerobic exercise
- Medical conditions or medication use that would preclude participation in aerobic exercise
- Medical conditions or medication use that would preclude participation in aerobic exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effects of acute exercise in heavy drinkersA 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. | Behavioural | Heavy drinkers |
| The effects of acute exercise in alcoholic patientsA 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. | Behavioural | Alcoholic patients |
Primary outcome
Changes in Urge to drink score
Time frame: Before (0 min) and after exercise trial (30 min)
According to questionnaire
Changes in Beta-endorphin levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Changes in Cortisol levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Changes in Adrenocorticotrophic hormone (ACTH) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured by radioimmunoassay (RIA)
Changes in C-reactive protein (CRP) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Semi-quantitative estimation with CRP Latex test kit
Changes in Complete blood count values
Time frame: Before (0 min) and after exercise trial (30 min)
Autoanalyzer
Changes in Lactic acid levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured using photometry
Changes in Erythrocyte sedimentation rate (ESR) values
Time frame: Before (0 min) and after exercise trial (30 min)
Wintrobe Method
Changes in γ-Glutamyltransferase (GGT) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Changes in Aspartate Aminotransferase (AST) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
Changes in Alanine Aminotransferase (ALT) levels
Time frame: Before (0 min) and after exercise trial (30 min)
Measured with commercial kit
4 secondary outcomes
Sit and reach flexibility test for the hamstrings muscles and lower back
Time frame: Before trial (baseline)
Grip strength
Time frame: Before trial (baseline)
Number of push-ups performed in one minute
Time frame: Before trial (baseline)
Number of sit-ups performed until exhaustion
Time frame: Before trial (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Results publication: PubMed 26668589Georgakouli K, Manthou E, Fatouros IG, Deli CK, Spandidos DA, Tsatsakis AM, Kouretas D, Koutedakis Y, Theodorakis Y, Jamurtas AZ. Effects of acute exercise on liver function and blood redox status in heavy drinkers. Exp Ther Med. 2015 Dec;10(6):2015-2022. doi: 10.3892/etm.2015.2792. Epub 2015 Oct 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannis Theodorakis, PhD study chair
University of Thessaly
Questions about this trial
What is this clinical trial studying?
A study testing The effects of acute exercise in heavy drinkers and The effects of acute exercise in alcoholic patients in people with Heavy Drinking and Alcohol Abuse, run by University of Thessaly.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Urge to drink score (time frame: Before (0 min) and after exercise trial (30 min)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.