Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT02636335
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light, Exercise Intensity and Mood in Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean power output in watts', 'timeFrame': 'Power output during the first 30 minute time-trial on a bicycle ergometer.'}], 'secondaryOutcomes': [{'measure': 'Subjective sleepiness', 'timeFrame': '1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial', 'description': 'Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")'}, {'measure': 'Subjective Mood', 'timeFrame': '1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial', 'description': 'Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")'}, {'measure': 'Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.', 'timeFrame': 'Mean of the 30 minutes of the exercise from the first, second and third time-trial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight, Obesity Grade I']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index 25 - 35 kg/m2\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding,\n* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant\n* Previous enrolment into the current study\n* Participation in other studies in the last four weeks\n* Systolic blood pressure \\> 170 mmHg, diastolic blood pressure \\> 100 mmHg\n* Shift work in the last two months\n* Travels across time zones in the last four weeks\n* Use of photosensitisation drugs\n* Clinical manifest depression\n* Cardiovascular diseases which reduce age-appropriate exercise capacity'}, 'identificationModule': {'nctId': 'NCT02636335', 'acronym': 'LEXI-MO', 'briefTitle': 'Light, Exercise Intensity and Mood in Overweight', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Light, Exercise Intensity and Mood in Overweight', 'orgStudyIdInfo': {'id': 'LEXI-MO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Light', 'description': '8 a.m. study participants will be exposed to Bright Light (4500 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer.\n\nThe light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart.', 'interventionNames': ['Device: Phillips Energy Light HF3319']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': '8 a.m. study participants will be exposed to a Control Light Condition (230 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer.\n\nThe light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart.', 'interventionNames': ['Device: Phillips Energy Light HF3319']}], 'interventions': [{'name': 'Phillips Energy Light HF3319', 'type': 'DEVICE', 'description': 'Exposure to Light administered with Phillips Energy Light HF3319.', 'armGroupLabels': ['Bright Light', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4052', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Departement of Sport, Exercise and Health', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Arno Schmidt-Trucksäss, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Departement of Sport, Exercise and Health, Principal Investigator', 'investigatorFullName': 'Arno Schmidt-Trucksäss', 'investigatorAffiliation': 'University of Basel'}}}}