Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-02 @ 1:00 PM
Study NCT ID:
NCT06398704
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2024-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonography Evaluation', 'timeFrame': 'Baseline', 'description': 'Anterior thigh muscle thickness will be measured to evaluate sarcopenia. The obtained value will be divided by the Body Mass Index. This evaluation method is referred to in the literature as the Sonographic T-high Adjustment Rate (STAR) method. Ultrasonographic measurements will be made by a physician with at least 10 years of experience in this field using linear probes.'}, {'measure': 'Evaluation of Inspiratory Muscle Strength', 'timeFrame': 'Baseline', 'description': 'Powerbreathe K5 device was used to evaluate inspiratory muscle strength. This device is a portable, easy-to-use, accessible and reliable device used for both education and treatment purposes and evaluation purposes.'}, {'measure': '2 Minute Step Test:', 'timeFrame': 'Baseline', 'description': 'The purpose of this test is to elevate the knees to the midpoint between the patella and the anterior-superior iliac crest. The 2 Minute Step Test is valid and reliable for assessing cardiorespiratory fitness in older adults.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geriatric Individuals']}, 'referencesModule': {'references': [{'pmid': '30272099', 'type': 'BACKGROUND', 'citation': 'Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4.'}, {'pmid': '35194529', 'type': 'BACKGROUND', 'citation': 'Sawaya Y, Shiba T, Ishizaka M, Hirose T, Sato R, Kubo A, Urano T. Sarcopenia is not associated with inspiratory muscle strength but with expiratory muscle strength among older adults requiring long-term care/support. PeerJ. 2022 Feb 17;10:e12958. doi: 10.7717/peerj.12958. eCollection 2022.'}, {'pmid': '34121127', 'type': 'BACKGROUND', 'citation': 'Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.'}, {'pmid': '32941253', 'type': 'BACKGROUND', 'citation': 'Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals.', 'detailedDescription': 'Within the scope of the study, anterior thigh thicknesses of geriatric individuals will be evaluated by ultrasonography and individuals will be divided into 3 groups as dynapenic, sarcopenic and normal according to the ISarcoPRM algorithm, using the STAR method and Hand-grip. The Powerbreathe K5 device will be used to evaluate the inspiratory muscle strength of geriatric individuals in both groups, and the 2-minute step test will be used to evaluate cardiorespiratory fitness. The study will be carried out with 100 geriatric individuals. As a result of the study, first the inspiratory muscle strength and cardiorespiratory fitness of sarcopenic, dynapenic and non-sarcopenic groups will be compared. Afterwards, the relationship between anterior thigh thickness and inspiratory muscle strength of all geriatric individuals participating in the study will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatric Individuals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Getting a score between 24 and 30 on the Mini Mental State Assessment\n* Ability to stand without assistance for at least 90 seconds\n\nExclusion Criteria:\n\n* Inability to communicate verbally\n* Using a walking aid\n* Older adults with severe visual impairment, neurological disorders, and/or congestive heart failure\n* Older adults for whom exercise is not recommended'}, 'identificationModule': {'nctId': 'NCT06398704', 'briefTitle': 'Investigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effects of Sarcopenia and Dynapenia on Inspiratory Muscle Strength and Cardiorespiratory Fitness in Geriatric Individuals', 'orgStudyIdInfo': {'id': 'E-59394181-604.01-83836'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcopenia Group', 'description': 'Individuals with sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip', 'interventionNames': ['Other: Standart of care']}, {'label': 'Dinapenia Group', 'description': 'Individuals with dynapenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip', 'interventionNames': ['Other: Standart of care']}, {'label': 'Non-sarcopenia Group', 'description': 'Individuals with non-sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip', 'interventionNames': ['Other: Standart of care']}], 'interventions': [{'name': 'Standart of care', 'type': 'OTHER', 'description': 'No additional intervention was made. An evaluation was made.', 'armGroupLabels': ['Dinapenia Group', 'Non-sarcopenia Group', 'Sarcopenia Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Atılım University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Süleyman Korkusuz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atılım University'}, {'name': 'Özlem Yürük, Prof.Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Baskent University'}, {'name': 'Büşra Seçkinoğulları Korkusuz, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ferdi Yavuz, Assoc.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'European University of Lefke'}, {'name': 'Hülya Arıkan, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Atılım University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suleyman Korkusuz', 'investigatorAffiliation': 'Hacettepe University'}}}}