Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00117520
Status:
COMPLETED
Last Update Posted:
2006-07-07
First Post:
2005-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Caffeine in Elderly Citizens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-07', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2006-07-03', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2006-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endurance measured on an ergometer bicycle'}], 'secondaryOutcomes': [{'measure': 'postural stability'}, {'measure': 'reactiontime'}, {'measure': 'isometric endurance (armflexion)'}, {'measure': 'walking speed'}, {'measure': 'fatigue'}]}, 'conditionsModule': {'keywords': ['caffeine, endurance, postural stability, elderly'], 'conditions': ['Healthy Elderly Citizens']}, 'descriptionModule': {'briefSummary': 'The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.', 'detailedDescription': 'Caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake, and it also seems to improve endurance as measured by repeated sub-maximal isometric contraction and decreases the rate of perceived exertion during exercise. Although caffeine increases endurance in young people, an increase in endurance may be of greater interest in the elderly as the population of older adults with a physically active lifestyle is growing rapidly or for increasing endurance fitness through an exercise or rehabilitation program. Therefore the main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate, and the secondary hypotheses were that caffeine would improve postural stability, reaction and movement times, isometric arm flexion endurance, and walking speed, and would reduce the rate of perceived exertion after 5 minutes of cycling in healthy elderly citizens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy elderly individuals aged over 70 years\n\nExclusion Criteria:\n\n* Dementia or invalidating psychiatric disease\n* General debility, angina, or other diseases that would render participation in the test program impossible\n* Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine\n* Acute disease and injury\n* Diabetes\n* Conditions that would contraindicate caffeine ingestion or participation in the test program\n* Treatment with medication that interacts with caffeine\n* Ingestion of caffeine containing drinks and foods 48 hours before each session'}, 'identificationModule': {'nctId': 'NCT00117520', 'briefTitle': 'The Effect of Caffeine in Elderly Citizens', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'The Effect of Caffeine as Endurance Enhancing Drug in the Elderly', 'orgStudyIdInfo': {'id': '2612-1987'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caffeine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'state': 'Ringkjoebing', 'country': 'Denmark', 'facility': 'Surgical Research Department', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Charlotte B Norager, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Research Department, Herning Hospital, DK-7400 Herning'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}}}}