Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT04444661
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2020-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SMI', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Skeletal muscle mass index (appendicular skeletal muscle mass / body height; kg/m2) as determined by Dual Energy x-Ray Absorptiometry'}], 'secondaryOutcomes': [{'measure': 'BMD-LS', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Bone Mineral Density at the Lumbar Spine as determined by Dual Energy x-Ray Absorptiometry'}, {'measure': 'BMD-hip', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Bone Mineral Density at the total hip as determined by Dual Energy x-Ray Absorptiometry'}, {'measure': 'Sarcopenia-Z-Score', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Z-Score of parameters constituting the metabolic syndrome (i.e. SMI, hand-grip strength, gait velocity)'}, {'measure': 'Fat infiltration thigh muscles', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging'}, {'measure': 'Fat infiltration para-vertebral muscles', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Intramuscular adipose tissue at the mid thigh as determined by Magnetic Resonance Imaging'}, {'measure': 'Maximum hip-/leg extensor strength', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Maximum hip-/leg extensor strength as determined by an isokinetic leg press'}, {'measure': 'Metabolic Syndrome Z-Score', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Metabolic Syndrome Z-Score based on the definition of the International Diabetes Federation including waist circumference, resting glucose, HDL-cholesterol, triglyzerides, mean arterial blood pressure)'}, {'measure': 'Self rated physical performance', 'timeFrame': 'Change from Baseline to 26 weeks', 'description': 'Late-Life Function and Disability Index of McAuley et al.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '32270891', 'type': 'BACKGROUND', 'citation': 'Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.'}, {'pmid': '31908428', 'type': 'BACKGROUND', 'citation': 'Lichtenberg T, von Stengel S, Sieber C, Kemmler W. The Favorable Effects of a High-Intensity Resistance Training on Sarcopenia in Older Community-Dwelling Men with Osteosarcopenia: The Randomized Controlled FrOST Study. Clin Interv Aging. 2019 Dec 16;14:2173-2186. doi: 10.2147/CIA.S225618. eCollection 2019.'}, {'pmid': '33249320', 'type': 'DERIVED', 'citation': 'Kemmler W, Kohl M, Frohlich M, Schoene D, von Stengel S. Detraining effects after 18 months of high intensity resistance training on osteosarcopenia in older men-Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). Bone. 2021 Jan;142:115772. doi: 10.1016/j.bone.2020.115772. Epub 2020 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort.\n\nThe aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '74 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of the FrOST study (men 72 years and older with osteosarcopenia)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants of the FrOST study (NCT03453463)\n\nExclusion Criteria:\n\n* medication and diseases with potential impact on study outcomes during the last 26 weeks.'}, 'identificationModule': {'nctId': 'NCT04444661', 'briefTitle': 'Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise in Older Men With Osteosarcopenia A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FrOST-FU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIT-resistance exercise', 'description': 'High Intensity Resistance Exercise'}, {'label': 'Non exercising control', 'description': 'Control group that maintained life style and physical activity habits'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'wolfgang Kemmler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'no limitation', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study are available from the corresponding author, \\[WK\\], upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}