Nctid:
NCT06614556
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009410", "term"=>"Nerve Degeneration"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M12354", "name"=>"Nerve Degeneration", "asFound"=>"Nerve Degeneration", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2024-09-17", "size"=>178308, "label"=>"Study Protocol and Statistical Analysis Plan", "hasIcf"=>false, "hasSap"=>true, "filename"=>"Prot_SAP_000.pdf", "typeAbbrev"=>"Prot_SAP", "uploadDate"=>"2024-09-17T10:17", "hasProtocol"=>true}, {"date"=>"2024-09-09", "size"=>384037, "label"=>"Informed Consent Form", "hasIcf"=>true, "hasSap"=>false, "filename"=>"ICF_001.pdf", "typeAbbrev"=>"ICF", "uploadDate"=>"2024-09-11T13:23", "hasProtocol"=>false}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"FACTORIAL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>59}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-09-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-07-18", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-12", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-07-18", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Motor nerve conduction velocity (m/s)", "timeFrame"=>"Before and after 4 weeks of training (or just 4 weeks, for controls)", "description"=>"Conduction velocity of the median nerve, via nerve stimulation, as measured through EMG at the Flexor Digitorum Superficialis muscle"}], "secondaryOutcomes"=>[{"measure"=>"Nerve cross-sectional area (mm^2)", "timeFrame"=>"Before and after 4 weeks of training (or just 4 weeks, for controls)", "description"=>"The area within the visible borders of the nerve, as seen and measured via ultrasound"}, {"measure"=>"Maximal strength (kg)", "timeFrame"=>"Before and after 4 weeks of training (or just 4 weeks, for controls)", "description"=>"Maximal handgrip strength using a handgrip dynamometer"}, {"measure"=>"Hand motor dexterity (seconds)", "timeFrame"=>"Before and after 4 weeks of training (or just 4 weeks, for controls)", "description"=>"A timed Minnesota manual dexterity task"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Nerve Degeneration", "Healthy Aging"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week resistance training intervention with nerve conduction velocity measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention.", "detailedDescription"=>"Studies have shown that nerve speed slows with advancing age. As a result, slower nerves may result in slower movement speed and can alter response time. The investigators propose that a resistance training intervention may elicit positive adaptations to the nerves. The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week, at-home, resistance training intervention with nerve conduction velocity (m/s) measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention. Other outcome measures included nerve size, via ultrasound, maximal handgrip strength, and hand dexterity."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Apparently healthy adults 18 - 100 years old.\n\nExclusion Criteria:\n\n* If you have been notified by a physician to refrain from exercise due to cardiovascular issues.\n* Known orthopedic or neuromuscular limitations or illness of the upper extremities.\n* Known neuromuscular disorders.\n* Individuals that are experiencing a fever (\\> 100.4° F) or have identified as symptomatic on the COVID-19 screening questionnaire may not participate at this time."}, "identificationModule"=>{"nctId"=>"NCT06614556", "briefTitle"=>"Quantifying the Trainability of Peripheral Nerve Function in Young and Older Adults.", "organization"=>{"class"=>"OTHER", "fullName"=>"Oklahoma State University"}, "officialTitle"=>"Quantifying the Trainability of Peripheral Nerve Function in Young and Older Adults.", "orgStudyIdInfo"=>{"id"=>"IRB-22-270"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Young Training Group", "description"=>"Ages 18-35. Performed 4 weeks of an at-home, hand grip resistance training intervention.", "interventionNames"=>["Other: Resistance Training"]}, {"type"=>"NO_INTERVENTION", "label"=>"Young Control Group", "description"=>"Ages 18-35. Did not perform the training intervention"}, {"type"=>"EXPERIMENTAL", "label"=>"Older Training Group", "description"=>"Ages 60+. Performed 4 weeks of an at-home, hand grip resistance training intervention.", "interventionNames"=>["Other: Resistance Training"]}, {"type"=>"NO_INTERVENTION", "label"=>"Older Control Group", "description"=>"Ages 60+. Did not perform the training intervention"}], "interventions"=>[{"name"=>"Resistance Training", "type"=>"OTHER", "otherNames"=>["Strength Training", "Exercise"], "description"=>"Participants in the training groups performed bilateral hand grip resistance training three times per week for four weeks using a specialized hand-grip kit provided to them. Participants were provided with pictures and instructions for each exercise upon completion of the initial testing (PRE) session. They were asked to perform 12 training sessions (approximately 30-45 mins) over the 4 weeks according to their schedule. Each participant was asked to keep a training log to assist with accountability. Those assigned to the control groups were asked to maintain their normal daily activities throughout the four weeks.", "armGroupLabels"=>["Older Training Group", "Young Training Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"74078", "city"=>"Stillwater", "state"=>"Oklahoma", "country"=>"United States", "facility"=>"Applied Neuromuscular Physiology Laboratory", "geoPoint"=>{"lat"=>36.11561, "lon"=>-97.05837}}], "overallOfficials"=>[{"name"=>"Jason M DeFreitas, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Oklahoma State University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Oklahoma State University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"American College of Sports Medicine - Central States Chapter", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
