Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-02 @ 6:19 AM
Study NCT ID:
NCT06477705
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Energy Cost of 1-Hour Football Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in exercise-induced energy expenditure', 'timeFrame': 'At pre-exercise, during, and post-exercise session (single bout lasting 60 minutes)', 'description': 'Exercise energy expenditure (kcal) will be measured using a portable indirect calorimetry system'}, {'measure': 'Change in excess post-exercise oxygen consumption (EPOC)', 'timeFrame': 'At post-exercise session (single bout lasting 60 minutes)', 'description': 'EPOC (kcal) will be measured using a portable indirect calorimetry system'}, {'measure': 'Change in blood lactate concentration (BLa)', 'timeFrame': 'At pre- and post-exercise session (single bout) at 3 minutes post-exercise', 'description': 'BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits.'}, {'measure': 'Change in heart rate', 'timeFrame': 'At pre-exercise, during, and post-exercise session (single bout lasting 60 minutes)', 'description': 'Heart rate (bpm) will be measured with a wearable heart rate monitor'}, {'measure': 'Change in perceived exertion', 'timeFrame': 'At pre-exercise and post-exercise session (single bout lasting 60 minutes)', 'description': 'Rating of perceived exertion (RPE) will be measured with the Borg scale (0-10)'}, {'measure': 'Respiratory Exchange Ratio (RER)', 'timeFrame': 'At pre-exercise, during, and post-exercise session (single bout lasting 60 minutes)', 'description': 'Respiratory Exchange Ratio (RER) will be measured using a portable indirect calorimetry system'}, {'measure': 'Breath Frequency (BF)', 'timeFrame': 'At pre-exercise, during, and post-exercise session (single bout lasting 60 minutes)', 'description': 'Breath Frequency (BF) will be measured using a portable indirect calorimetry system'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'At baseline', 'description': 'Body weight will be measured on a beam balance with stadiometer'}, {'measure': 'Body height', 'timeFrame': 'At baseline', 'description': 'Body height will be measured on a beam balance with stadiometer'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'At baseline', 'description': "BMI will be calculated using the Quetelet's equation"}, {'measure': 'Waist circumference (WC)', 'timeFrame': 'At baseline', 'description': 'WC (cm) will be measured using a Gullick II tape'}, {'measure': 'Hip circumference (HC)', 'timeFrame': 'At baseline', 'description': 'HC (cm) will be measured using a Gullick II tape'}, {'measure': 'Waist-to-hip ratio (WHR)', 'timeFrame': 'At baseline', 'description': 'WHR will be calculated by dividing the waist by the hip measurement'}, {'measure': 'Resting metabolic rate (RMR)', 'timeFrame': 'At baseline', 'description': 'RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system'}, {'measure': 'Body fat (BF)', 'timeFrame': 'At baseline', 'description': 'Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Fat mass (FM)', 'timeFrame': 'At baseline', 'description': 'FM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Fat-free mass (FFM)', 'timeFrame': 'At baseline', 'description': 'FFM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Bone mass density', 'timeFrame': 'At baseline', 'description': 'Bone mass density will be measured by using Dual-emission X-ray absorptiometry'}, {'measure': 'Bone mass content', 'timeFrame': 'At baseline', 'description': 'Bone mass content will be measured by using Dual-emission X-ray absorptiometry'}, {'measure': 'Peak Maximal oxygen consumption (Peak VO2)', 'timeFrame': 'At baseline', 'description': 'Peak VO2 will be estimated by open circuit spirometry via breath by breath method'}, {'measure': 'Dietary intake', 'timeFrame': 'At baseline', 'description': 'Dietary intake will be assesed over a 7-day period using diet recalls'}, {'measure': 'Field activity during the soccer training', 'timeFrame': '[Time Frame: During the 60 minutes soccer training (ST) session (72 hours after baseline measurements)', 'description': 'The field activity will be continuously monitored during the soccer training using global positioning system (GPS)'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'At baseline', 'description': 'Systolic Blood Pressure will be examined using sphygmomanometer'}, {'measure': 'Dystolic Blood Pressure', 'timeFrame': 'At baseline', 'description': 'Dystolic Blood Pressure will be examined using sphygmomanometer'}, {'measure': 'Rest Heart Rate', 'timeFrame': 'At baseline', 'description': 'The rest heart rate will be estimated using a heart rate monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Football training', 'Energy Expenditure', 'Oxygen consumption', 'Blood lactate', 'Metabolic Syndrome'], 'conditions': ['Energy Expenditure', 'Body Composition', 'Resting Metabolic Rate', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims at investigating the energy expenditure following a single Football trainning session in middle aged males. The participants will perform a soccer training session \\[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design.', 'detailedDescription': 'Football is an intermittent sport with frequent activity changes and a high number of explosive movements. As a result, both mitochondrial and the non-mitochondrial energy sources (phosphagens, lactic acid system) are heavily utilized during football practice and games, which may contribute to the rise of oxygen consumption following exercise (EPOC) compared with cardiovascular-type exercise, where VO2 can reach a steady state.However, it is observed that there is a methodological limitation in the determination of total energy expenditure during and after football training and specifically in overwight middle-aged participans with metabolic syndrome.\n\nTwenty overweight middle-aged males with mtabolic syndrome will perform a soccer training session \\[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Anthropometric, biochmeistry indicators, metabolic, blood pressure, physical activity and performance measurements will be measured at baseline. Global positoning system and accelerometry devices will be used to measure the distance and intensity of football trianing. The metabolic cost will be estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free of musculoskeletal injuries\n* No use of ergogenic supplements or medication\n* Free of chronic diseases\n* age of 40-60 years\n* BMI\\>25\n* Metabolic syndrome\n\nExclusion Criteria:\n\n* Musculoskeletal injury\n* Use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study'}, 'identificationModule': {'nctId': 'NCT06477705', 'acronym': 'FAM', 'briefTitle': 'The Energy Cost of 1-Hour Football Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Energy Expenditure Induced by Football Training in Overweight Middle-aged Males', 'orgStudyIdInfo': {'id': 'FAM_EE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this arm will receive no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Recreational Football Training', 'description': 'Participants in this arm will participate in a football training session for 60 minutes. During the training the participans will execute the warm-up process, the part of soccer technical exercises and they will play a small-side-game.', 'interventionNames': ['Other: FAM']}], 'interventions': [{'name': 'FAM', 'type': 'OTHER', 'description': 'Participants will perform a recreational Football Training session for 60 minutes. The training will include the warm-up, soccer technical exercises and a small-side game', 'armGroupLabels': ['Recreational Football Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Trikala', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Ioannis G Fatouros, Prof', 'role': 'CONTACT', 'email': 'ifatouros@pe.uth.gr', 'phone': '+30 24310 47047'}, {'name': 'Athanasios Z Jamurtas, Prof', 'role': 'CONTACT', 'email': 'ajamurt@pe.uth.gr', 'phone': '+30 24310 47047'}, {'name': 'Dimitrios Brisimitzis, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laboratory of Exercise Physiology, Exercise Biochemistry and Sports Nutrition, School of Physical Education, Sports Sciences and Dietetics, University of Thessaly', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'centralContacts': [{'name': 'Ioannis G Fatouros, Prof', 'role': 'CONTACT', 'email': 'ifatouros@.pe.uth.gr', 'phone': '+30 24310 47047'}, {'name': 'Athanasios Z Jamurtas, Prof', 'role': 'CONTACT', 'email': 'ajamurt@pe.uth.gr', 'phone': '+30 24310 47054'}], 'overallOfficials': [{'name': 'Ioannis G Fatouros', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Thessaly'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ioannis G. Fatouros', 'investigatorAffiliation': 'University of Thessaly'}}}}