Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-30 @ 12:38 PM
Study NCT ID:
NCT02310334
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2014-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pacing (Guided Vs Unguided) Strategies Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological Strain Index (PSI)', 'timeFrame': 'During 2-hour exercise session', 'description': 'The PSI is an index that combines heart rate and core body temperatures with equal weights into an index from 0 to 10+. PSI will be calculated according to Moran et al. (1998) from measures of heart rate and core body temperature.'}], 'secondaryOutcomes': [{'measure': 'Metabolic Flexibility', 'timeFrame': '24 hours', 'description': 'O2 utilization and CO2 production will be analyzed during each calorimeter stay and used to measure metabolic rate indirectly.'}, {'measure': 'Continuous Glucose Monitoring', 'timeFrame': '24 hours', 'description': 'Continuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.'}, {'measure': 'Self Perception Scales', 'timeFrame': 'During 2-hour exercise session', 'description': 'Self perception scales will be used that measure mood state, perceived exertion, thermal sensation, physical stresses and motivation.'}, {'measure': 'Profile of Mood States (POMS) Questionnaire', 'timeFrame': 'During 2-hour exercise session', 'description': 'The POMS is an inventory of subjective mood states (McNair, Lorr and Droppleman, 1992).'}, {'measure': 'Thermal Sensation Scale', 'timeFrame': 'During 2-hour exercise session', 'description': 'Two thermal sensation scales (original and modified) will be used to assess the thermal sensation of volunteers.'}, {'measure': 'Perceived Exertion Scale', 'timeFrame': 'During 2-hour exercise session', 'description': 'The Borg (1970) rating of perceived exertion (RPE) will be used.'}, {'measure': 'Feeling Scale', 'timeFrame': 'During 2-hour exercise session', 'description': 'The feeling scale will be used as an affective valence measure of exercise.'}, {'measure': 'Motivation', 'timeFrame': 'During 2-hour exercise session', 'description': 'Question will be asked to assess motivation during each exercise session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Body Temperature Changes']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.', 'detailedDescription': 'This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a \\~24 hour stay in an indirect calorimetry chamber.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and Female\n* Ages 18 to 29 at the beginning of the study\n* Relatively fit can run 2 miles in under 16 minutes\n\nExclusion Criteria:\n\n* History of Skin Sensitivity to Nickel\n* Hypertension\n* Alcoholism\n* Diabetes\n* Pregnant\n* Age \\>29\n* Cannot run 2 miles in less than 16 minutes\n* No regular weekly exercise\n* Difficulty Swallowing Food or Large Pills\n* Diverticulitis\n* Inflammatory Bowel Disease\n* Peptic Ulcer Disease\n* Crohn's Disease\n* Ulcerative Colitis\n* Previous Gastrointestinal Surgery\n* Possible Nuclear Magnetic Resonance Scan\n* Women who have given birth during the previous 12 months\n* Pregnant women or women who plan to become pregnant or become pregnant during the study\n* Lactating women\n* History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes\n* History of bariatric or certain other surgeries related to weight control\n* Smokers or other tobacco users (for at least 6 months prior to the start of the study)\n* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)\n* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months\n* Unable or unwilling to give informed consent or communicate with study staff.\n* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)\n* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol\n* Blood donation within the previous month"}, 'identificationModule': {'nctId': 'NCT02310334', 'briefTitle': 'The Pacing (Guided Vs Unguided) Strategies Study', 'organization': {'class': 'FED', 'fullName': 'USDA Beltsville Human Nutrition Research Center'}, 'officialTitle': 'The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans', 'orgStudyIdInfo': {'id': 'HS47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unguided Pacing Strategy', 'description': 'Each participant will stay in the calorimeter (\\~24 hrs) on 2 different occasions. During the first visit, the participant will partake in an unguided exercise session.', 'interventionNames': ['Other: Guided Exercise Session']}, {'type': 'EXPERIMENTAL', 'label': 'Guided Pacing Strategy', 'description': 'Each participant will stay in the calorimeter (\\~24 hrs) on 2 different occasions. During the second visit, the participant will partake in a guided exercise session.', 'interventionNames': ['Other: Unguided Exercise Session']}], 'interventions': [{'name': 'Guided Exercise Session', 'type': 'OTHER', 'description': 'Participants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already.', 'armGroupLabels': ['Unguided Pacing Strategy']}, {'name': 'Unguided Exercise Session', 'type': 'OTHER', 'description': 'Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.', 'armGroupLabels': ['Guided Pacing Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20705', 'city': 'Beltsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Beltsville Human Nutrition Research Center', 'geoPoint': {'lat': 39.03483, 'lon': -76.90747}}], 'overallOfficials': [{'name': 'William V Rumpler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Beltsville Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Beltsville Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resesarch Physiologist', 'investigatorFullName': 'William Rumpler', 'investigatorAffiliation': 'USDA Beltsville Human Nutrition Research Center'}}}}