Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 9:10 AM
Study NCT ID:
NCT04019132
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Power During Functional Tasks in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower limb muscle power during a stair climb test', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'The power (watt) needed to perform stair climbing is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant'}, {'measure': 'Lower limb muscle power during a sit-to-stand test', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'The power (watt) needed to perform 5 sit-to-stand transitions and a 30 sec. sit-to-stand test is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant'}, {'measure': 'Reliability of power measurements measured with a 3D accelerometer', 'timeFrame': '1 test moment of approximately 30 minutes, planned between September 2019 and July 2020', 'description': 'Reliability of power measurements (watt) measured with a 3D accelerometer (DynaPort MoveTest, McRoberts) worn during functional activities (stair climbing, sit-to-stand test) three times within a period of 2 weeks'}, {'measure': 'Rate of power (force-velocity) development', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Participants perform a test protocol on a Biodex Dynamometer. The rate of power development (watt/s) is defined as the linear slope of the power-time curve and is measured from the onset of movement till peak power.'}, {'measure': 'Handgrip strength', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Handgrip strength (kg) evaluated with a Jamar dynamometer'}, {'measure': 'Jumping height', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Jumping height (in cm) measured during a standardized jump test'}, {'measure': 'Physical activity', 'timeFrame': '1 week', 'description': 'Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry'}, {'measure': 'Number of steps/stairs a day', 'timeFrame': '1 week', 'description': 'Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry'}], 'secondaryOutcomes': [{'measure': 'Number of repetitions during a 30s sit-to-stand test', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Number of complete sit-to-stand transitions in 30 sec.'}, {'measure': '6min walk distance', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'The walk distance (in m) covered in 6 min.'}, {'measure': 'Balance', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Number of seconds a participant can hold a tandem stand, a semi-tandem stand or with the feet together'}, {'measure': 'Maximal gait speed', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'The average speed to walk 3m as fast as possible (in m/s)'}, {'measure': 'Usual gait speed', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'The average speed to walk 4m at a usual pace (in m/s)'}, {'measure': 'Maximal isometric strength', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Maximal strength (Nm) is measured by means of unilateral isometric knee-extensor tests on a Biodex Dynamometer'}, {'measure': 'Maximal isokinetic strength', 'timeFrame': '1 test moment of approximately 1 hour, planned between September 2019 and July 2020', 'description': 'Maximal strength (Nm) is measured by means of unilateral isokinetic knee-extensor tests on a Biodex Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle Power', 'Functional capacity'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to optimize the methodology to measure lower limb power in older adults, so that clinicians are able to detect functional problems in this population earlier.', 'detailedDescription': 'Aging is associated with slower movement patterns, a higher fall risk and a restriction in functionality. This will lead to an increase in the number of dependent elderly and a high socio-economic burden. From the age of 40, a systematic loss of muscle mass and muscle force, also known as sarcopenia, will occur. In addition, performing daily tasks requires the production of muscle force at a certain speed. The product of force and speed, power, decreases even earlier and faster than muscle force.\n\nThis power is typically measured with specialized equipment, which limits the large-scale applicability. With the help of accelerometry there is the possibility to measure power during more functional tasks and movements, which benefits the applicability, but the reliability, reference values and link with other outcome measurements related to sarcopenia has to be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young to older adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>20\n\nExclusion Criteria:\n\n* Unstable cardiovascular diseases\n* Fever or acute infection\n* Cognitive or physical malfunctioning that hinders the understanding or performance of tests and/or instructions'}, 'identificationModule': {'nctId': 'NCT04019132', 'briefTitle': 'Power During Functional Tasks in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Power During Functional Tasks in Older Adults: Reliability, Reference Values and Relationship With Other Outcome Measurements Related to Sarcopenia', 'orgStudyIdInfo': {'id': 'S62540'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Older adults', 'description': 'Older adults aged \\>65 years', 'interventionNames': ['Diagnostic Test: Muscle function test']}, {'label': 'Young group', 'description': 'Younger adults between the age of 20 and 40 years', 'interventionNames': ['Diagnostic Test: Muscle function test']}, {'label': 'Middle-aged group 1', 'description': 'Adults between the age of 40 and 55 years', 'interventionNames': ['Diagnostic Test: Muscle function test']}, {'label': 'Middle-aged group 2', 'description': 'Adults between the age of 55 and 65 years', 'interventionNames': ['Diagnostic Test: Muscle function test']}], 'interventions': [{'name': 'Muscle function test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Body measurements, power and strength tests of the knee extensor muscle, handgrip strength, functional capacity tests, objective measurement of physical activity (subgroup of older adults, n=50)', 'armGroupLabels': ['Middle-aged group 1', 'Middle-aged group 2', 'Older adults', 'Young group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'KU Leuven - Department of Movement Sciences', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}