Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-04-21 @ 10:28 AM
Study NCT ID:
NCT04614857
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on metabolic energy expenditure', 'timeFrame': '1 hour', 'description': 'All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)'}], 'secondaryOutcomes': [{'measure': 'Change on muscle activity', 'timeFrame': '1 hour', 'description': 'All subjects underwent measurements of muscle activity during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle activity', 'Cardiopulmonary metabolic cost'], 'conditions': ['Gait']}, 'referencesModule': {'references': [{'pmid': '34425788', 'type': 'DERIVED', 'citation': 'Kim J, Lee HJ, Lee SH, Lee J, Chang WH, Ryu GH, Kim YH. Correlation between cardiopulmonary metabolic energy cost and lower-limb muscle activity during inclined treadmill gait in older adults. BMC Geriatr. 2021 Aug 23;21(1):469. doi: 10.1186/s12877-021-02401-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.', 'detailedDescription': 'The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.\n\nMetabolic energy expenditure and muscle activity are measured simultaneously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 65 and 84 years elderly without neurological effects\n* Ability to independent gait at least 16% inclined treadmill\n* High levels of physical performance (SPPB \\> 7)\n\nExclusion Criteria:\n\n* Severe visual impairment or dizziness that increases the risk of falls\n* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure, documentedserious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy,severe aortic stenosis, angina or dyspnea at rest or during activities ofdaily living)\n* Difficult to understand experimental tasks because of extremely severe cognitive impairment\n* Recent acute injuries such as fractures within 6 months, or experience in orthopedic surgery such as artificial joint replacement\n* Acute injuries such as fractures within 6 months or orthopedic surgery such as artificial joint replacement'}, 'identificationModule': {'nctId': 'NCT04614857', 'briefTitle': 'Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity During Inclined Treadmill Gait in the Elderly', 'orgStudyIdInfo': {'id': '2020-08-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inclined treadmill gait', 'description': 'All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)', 'interventionNames': ['Other: Inclined treadmill gait']}], 'interventions': [{'name': 'Inclined treadmill gait', 'type': 'OTHER', 'description': 'All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)', 'armGroupLabels': ['Inclined treadmill gait']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yun-Hee Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}