Heavy DrinkingNCT02664766
Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
A study testing Exercise training program 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 long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder
- What is being tested?
- Exercise training program
- 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 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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) Alcohol Use Disorders Identification Test (AUDIT) score>8
Who cannot join
- Medical conditions or medication use that would preclude participation in aerobic exercise
About this study
Official title: Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers
The purpose of this research is to examine the effects of long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse.
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, research is limited. The present study investigates whether exercise can act as adjunct therapy for alcohol abuse cessation.
One of the basic assumptions is that the appropriate form of exercise in alcoholics 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, 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 (current study), 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.
- Conditions
- Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder
- Being tested
- Exercise training program
- Keywords
- Heavy drinking, Heavy drinking cessation, Alcohol abuse, alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training programBehavioural
Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Participants will be recording their daily alcohol consumption. Participants will also undergo three trials of acute exercise (before, at the 4th week and at the 8th week of exercise training) in order to investigate whether exercise training can lead to changes in acute responses to exercise. Each trial involves 30 min of exercise on a cycle ergometer at 50-60% HRR.
| Study group | Role | What they receive |
|---|---|---|
| Control condition | No intervention | Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period. |
| Exercise training program | Experimental | Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Receives: Behavioral: Exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alcohol consumption (grams of alcohol consumed weekly)
Self-recorded
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Changes in Beta-endorphin levels
Measured by radioimmunoassay (RIA)
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Secondary outcomes (15)
Urge to drink
According to questionnaire
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Cortisol
Measured by radioimmunoassay (RIA)
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Adrenocorticotrophic hormone (ACTH)
Measured by radioimmunoassay (RIA)
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Catecholamines (epinephrine, norepinephrine, dopamine)
Measured by radioimmunoassay (RIA)
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
C-reactive protein (CRP)
Semi-quantitative estimation with CRP Latex test kit
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Complete blood count
Autoanalyzer Autoanalyzer Autoanalyzer
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Lactic acid
Measured using photometry
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Erythrocyte sedimentation rate (ESR)
Wintrobe Method
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
γ-Glutamyltransferase (GGT)
Measured with commercial kit
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Aspartate Aminotransferase (AST)
Measured with commercial kit
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Alanine Aminotransferase (ALT)
Measured with commercial kit
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Grip strength
Handgrip strength test
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Number of push-ups performed in one minute
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Number of sit-ups performed until exhaustion
Measured: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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 completionJul 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- 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
- NCT02664766
- Sponsor's protocol ID
- UThessaly 2
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers
- ClinicalTrials.gov ID
- NCT02664766
- Acronym / sponsor ID
- UThessaly 2
- Conditions
- Heavy Drinking, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- Heavy drinking, Heavy drinking cessation, Alcohol abuse, alcohol use disorder
- 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
- Jul 2014 (actual)
- Study completion
- Jun 2015 (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 long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse.
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, research is limited. The present study investigates whether exercise can act as adjunct therapy for alcohol abuse cessation.
One of the basic assumptions is that the appropriate form of exercise in alcoholics 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, 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 (current study), 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
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control condition | No intervention | –Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period. |
| Exercise training program | Experimental | Behavioral: Exercise training programSupervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 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) Alcohol Use Disorders Identification Test (AUDIT) score>8
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Exercise training programSupervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Participants will be recording their daily alcohol consumption. Participants will also undergo three trials of acute exercise (before, at the 4th week and at the 8th week of exercise training) in order to investigate whether exercise training can lead to changes in acute responses to exercise. Each trial involves 30 min of exercise on a cycle ergometer at 50-60% HRR. | Behavioural | Exercise training program |
Primary outcome
Changes in alcohol consumption (grams of alcohol consumed weekly)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Self-recorded
Changes in Beta-endorphin levels
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Measured by radioimmunoassay (RIA)
15 secondary outcomes
Urge to drink
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Cortisol
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Adrenocorticotrophic hormone (ACTH)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Catecholamines (epinephrine, norepinephrine, dopamine)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
C-reactive protein (CRP)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Complete blood count
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Lactic acid
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Erythrocyte sedimentation rate (ESR)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
γ-Glutamyltransferase (GGT)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Aspartate Aminotransferase (AST)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Alanine Aminotransferase (ALT)
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Sit and reach flexibility test for the hamstrings muscles and lower back
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Grip strength
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Number of push-ups performed in one minute
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
Number of sit-ups performed until exhaustion
Time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention
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 27 Jan 2016.
- 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 Exercise training program 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 2 inclusion and 1 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 27 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 alcohol consumption (grams of alcohol consumed weekly) (time frame: At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2016.