Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 1:41 AM
Study NCT ID:
NCT02664766
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Long-term Exercise on Various Parameters in Heavy Drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in alcohol consumption (grams of alcohol consumed weekly)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Self-recorded'}, {'measure': 'Changes in Beta-endorphin levels', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured by radioimmunoassay (RIA)'}], 'secondaryOutcomes': [{'measure': 'Urge to drink', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'According to questionnaire'}, {'measure': 'Cortisol', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured by radioimmunoassay (RIA)'}, {'measure': 'Adrenocorticotrophic hormone (ACTH)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured by radioimmunoassay (RIA)'}, {'measure': 'Catecholamines (epinephrine, norepinephrine, dopamine)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured by radioimmunoassay (RIA)'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Semi-quantitative estimation with CRP Latex test kit'}, {'measure': 'Complete blood count', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Autoanalyzer Autoanalyzer Autoanalyzer'}, {'measure': 'Lactic acid', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured using photometry'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Wintrobe Method'}, {'measure': 'γ-Glutamyltransferase (GGT)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured with commercial kit'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured with commercial kit'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Measured with commercial kit'}, {'measure': 'Sit and reach flexibility test for the hamstrings muscles and lower back', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': '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.'}, {'measure': 'Grip strength', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention', 'description': 'Handgrip strength test'}, {'measure': 'Number of push-ups performed in one minute', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention'}, {'measure': 'Number of sit-ups performed until exhaustion', 'timeFrame': 'At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heavy drinking', 'Heavy drinking cessation', 'Alcohol abuse', 'alcohol use disorder'], 'conditions': ['Heavy Drinking', 'Alcohol Abuse', 'Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSeveral 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.\n\nOne 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* 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\n\nExclusion Criteria:\n\n* Medical conditions or medication use that would preclude participation in aerobic exercise'}, 'identificationModule': {'nctId': 'NCT02664766', 'briefTitle': 'Effects of Long-term Exercise on Various Parameters in Heavy Drinkers', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Effects of Long-term Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Heavy Drinkers', 'orgStudyIdInfo': {'id': 'UThessaly 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control condition', 'description': 'Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise training program', 'description': 'Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week.', 'interventionNames': ['Behavioral: Exercise training program']}], 'interventions': [{'name': 'Exercise training program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Exercise training program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yannis Theodorakis, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Social Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Athanasios Z. Jamurtas', 'investigatorAffiliation': 'University of Thessaly'}}}}