Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT03794050
Status:
TERMINATED
Last Update Posted:
2023-03-24
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Acute Aerobic and Resistance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to complete enrollment of all participants in a timely manner. Data analyses and publications will occur with the participants who did complete the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocyte subset and function', 'timeFrame': 'Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise', 'description': 'Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function'}, {'measure': 'Monocyte subset and function', 'timeFrame': 'Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise', 'description': 'Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function'}, {'measure': 'Monocyte subset and function', 'timeFrame': 'compare pre-RT to pre-AT', 'description': 'Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function'}, {'measure': 'Monocyte subset and function', 'timeFrame': 'compare immediately post-RT to immediately post-AT', 'description': 'Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function'}, {'measure': 'Monocyte subset and function', 'timeFrame': 'compare 1hr post-RT to 1hr post-AT', 'description': 'Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function'}, {'measure': 'NK cell function', 'timeFrame': 'Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise', 'description': 'Flow cytometry to identify NK cells and in vitro activity to assess NK activity'}, {'measure': 'NK cell function', 'timeFrame': 'Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise', 'description': 'Flow cytometry to identify NK cells and in vitro activity to assess NK activity'}, {'measure': 'NK cell function', 'timeFrame': 'compare pre-RT to pre-AT', 'description': 'Flow cytometry to identify NK cells and in vitro activity to assess NK activity'}, {'measure': 'NK cell function', 'timeFrame': 'compare immediately post-RT to immediately post-AT', 'description': 'Flow cytometry to identify NK cells and in vitro activity to assess NK activity'}, {'measure': 'NK cell function', 'timeFrame': 'compare 1hr post-RT to 1hr post-AT', 'description': 'Flow cytometry to identify NK cells and in vitro activity to assess NK activity'}, {'measure': 'Circulating relative and absolute counts of T cell subsets', 'timeFrame': 'Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise', 'description': 'Flow cytometry to identify T cell subsets'}, {'measure': 'Circulating relative and absolute counts of T cell subsets', 'timeFrame': 'Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise', 'description': 'Flow cytometry to identify T cell subsets'}, {'measure': 'Circulating relative and absolute counts of T cell subsets', 'timeFrame': 'compare pre-RT to pre-AT', 'description': 'Flow cytometry to identify T cell subsets'}, {'measure': 'Circulating relative and absolute counts of T cell subsets', 'timeFrame': 'compare immediately post-RT to immediately post-AT', 'description': 'Flow cytometry to identify T cell subsets'}, {'measure': 'Circulating relative and absolute counts of T cell subsets', 'timeFrame': 'compare 1hr post-RT to 1hr post-AT', 'description': 'Flow cytometry to identify T cell subsets'}], 'secondaryOutcomes': [{'measure': 'Serum cortisol', 'timeFrame': 'Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise', 'description': 'ELISA to measure circulating cortisol (serum)'}, {'measure': 'Serum cortisol', 'timeFrame': 'Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise', 'description': 'ELISA to measure circulating cortisol (serum)'}, {'measure': 'Serum cortisol', 'timeFrame': 'compare pre-RT to pre-AT', 'description': 'ELISA to measure circulating cortisol (serum)'}, {'measure': 'Serum cortisol', 'timeFrame': 'compare immediately post-RT to immediately post-AT', 'description': 'ELISA to measure circulating cortisol (serum)'}, {'measure': 'Serum cortisol', 'timeFrame': 'compare 1hr post-RT to 1hr post-AT', 'description': 'ELISA to measure circulating cortisol (serum)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Physiology']}, 'referencesModule': {'references': [{'pmid': '35616304', 'type': 'DERIVED', 'citation': 'Graff RM, Jennings K, LaVoy ECP, Warren VE, Macdonald BW, Park Y, Markofski MM. T-cell counts in response to acute cardiorespiratory or resistance exercise in physically active or physically inactive older adults: a randomized crossover study. J Appl Physiol (1985). 2022 Jul 1;133(1):119-129. doi: 10.1152/japplphysiol.00301.2021. Epub 2022 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise.', 'detailedDescription': 'Young and middle-aged to older adults who are physically active or not physically active will participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and resistance training exercise. Blood will be collected to assess immune function and metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* "Young" Adults: ages 18-30\n* "Older" Adults: ages 55-75 and if a female postmenopausal\n* Participants classified as "trained" must participate in at least 30 minutes of moderate to vigorous intensity cardiovascular activity at least 3 days per week and engage in resistance training for all of the major muscle groups approximately 2 days / week. They must have upheld this activity for the past 3 months\n* Participants classified as "untrained" must be participating in less than 30 minutes of moderate to vigorous intensity cardiovascular activity and less than 2 days of resistance training per week for at least the last 3 months.\n\nExclusion Criteria:\n\n* Have any contraindications to moderate to vigorous exercise\n* Range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)\n* aking medications (prescription or over the counter) known to influence immune function, including daily NSAID\'s, beta blockers, statins, bisphosphonates, or steroids.\n* Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).\n* Be pregnant\n* Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study which will span several weeks)\n* Fall outside of a BMI range of (18.5 - 30)\n* Consume alcohol or recreational drugs for 24h prior to visits\n* Older women cannot be pre-menopausal (must have not had a menses for at least 12 months)\n* Unable to speak or read English\n* Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 4 times over the course of the study'}, 'identificationModule': {'nctId': 'NCT03794050', 'acronym': 'CAARE', 'briefTitle': 'Comparing Acute Aerobic and Resistance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Effects of Age, Fitness Level, and Modality on Physiological Response to Acute Exercise', 'orgStudyIdInfo': {'id': 'STUDY00001191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'resistance training exercise', 'description': 'All participants complete one session of resistance training exercise', 'interventionNames': ['Other: Resistance training exercise']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic training exercise', 'description': 'All participants complete one session of aerobic training exercise', 'interventionNames': ['Other: Aerobic training exercise']}], 'interventions': [{'name': 'Resistance training exercise', 'type': 'OTHER', 'description': 'randomized complete crossover for acute resistance training exercise session', 'armGroupLabels': ['resistance training exercise']}, {'name': 'Aerobic training exercise', 'type': 'OTHER', 'description': 'randomized complete crossover for acute aerobic exercise training exercise session', 'armGroupLabels': ['aerobic training exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Melissa Markofski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are considering making available IDP to others upon request, but would have to get an IRB change because that is not in our protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melissa M Markofski', 'investigatorAffiliation': 'University of Houston'}}}}