Nctid:
NCT06611969
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000053120", "term"=>"Respiratory Aspiration"}], "ancestors"=>[{"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M27137", "name"=>"Respiratory Aspiration", "asFound"=>"Inspiratory", "relevance"=>"HIGH"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M6392", "name"=>"Complement System Proteins", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"The evaluators are unaware of the assignment at all times. Outcomes assessor will discover group assigment after data analysis."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>38}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-26", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-13", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Expiratory forced volume in first second", "timeFrame"=>"Before starting the intervention and after its completion (12 weeks)", "description"=>"FEV1, in liters/second, assessed by spirometry"}], "secondaryOutcomes"=>[{"measure"=>"Hearth rate variability", "timeFrame"=>"From the beginning to the end of the programme, recorded on a daily basis.", "description"=>"In miliseconds, assessed by hearth rate monitor"}, {"measure"=>"Hearth rate", "timeFrame"=>"From the beginning to the end of the programme, recorded on a daily basis.", "description"=>"Maximal and specifically in rest, measured in beats per minute, assessed by heart rate monitor"}, {"measure"=>"Respiratory rate", "timeFrame"=>"From the beginning to the end of the programme, recorded on a daily basis.", "description"=>"Measured in respirations per minute, estimated by the hearth rate monitor."}, {"measure"=>"Running performance", "timeFrame"=>"From the beginning to the end of the programme, recorded on a daily basis.", "description"=>"Measured by running pace (time per kilometre) and perceived exertion (modified Borg scale 0-10), recorded individually in a written register."}, {"measure"=>"Maximal inspiratory pressure", "timeFrame"=>"Before starting the intervention and after its completion (12 weeks)", "description"=>"MIP, in cmH2O, assessed by inspiratory manouever"}, {"measure"=>"Maximal consumption of oxygen", "timeFrame"=>"Before starting the intervention and after its completion (12 weeks)", "description"=>"VO2 max, in ml/kg/min, estimated by heart rate monitor in training efforts."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["inspiratory muscle training", "respiratory function", "performance", "exercise"], "conditions"=>["Amateur Athletes"]}, "descriptionModule"=>{"briefSummary"=>"The main objective of the study is to study the changes in FEV1 with the introduction of the specific inspiratory muscle training programme in the training programme of the popular athletes included. In addition, the secondary aims are to observe the differences in the respiratory capacities of the patients, in the vital signs, VO2 max, respiratory frequency and cardiac variability, as well as to assess the running performance of the participants.\n\nParticipants will be assigned to one of 2 study groups: IMT group (n=20) or not-IMT group (n=20) The IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan. The not-IMT group will follow only the conventional marathon training plan. The study will be conducted over a 12 week period."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Individuals willing to follow the 16-week running training plan\n* Possibility of combining aerobic training with inspiratory muscle training\n* Previous half marathon runner\n\nExclusion Criteria:\n\n* - Exclusive or professional dedication to athletics\n* Previous or current use of respiratory muscle training.\n* Inadequate or health risk physical condition\n* Significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD).\n* Neurological, muscular or neuromuscular problems that interfere with the ability to participate in tests and training protocols.\n* Discontinuity in the performance of training.\n* A terminal illness or any other major medical contraindication\n* Lack of informed consent"}, "identificationModule"=>{"nctId"=>"NCT06611969", "briefTitle"=>"Inspiratory Muscle Training in Amateur Athletes", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Valencia"}, "officialTitle"=>"Effects of Inspiratory Muscle Training As a Complement to Usual Training on Respiratory Function and Performance in Amateur Athletes", "orgStudyIdInfo"=>{"id"=>"2024-FIS-3390079"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Inspiratory muscle training (IMT) plus conventional training group", "description"=>"IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan", "interventionNames"=>["Procedure: Exercise"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Conventional training group (not-IMT) group", "description"=>"The not-IMT group will follow only the conventional marathon training plan", "interventionNames"=>["Procedure: Exercise"]}], "interventions"=>[{"name"=>"Exercise", "type"=>"PROCEDURE", "description"=>"The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility, plus specific training of the inspiratory muscles, 3 times a week, at a load between 50 and 80% of the maximum inspiratory pressure of each participant, after re-education of their diaphragmatic ventilation.", "armGroupLabels"=>["Inspiratory muscle training (IMT) plus conventional training group"]}, {"name"=>"Exercise", "type"=>"PROCEDURE", "description"=>"The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility.", "armGroupLabels"=>["Conventional training group (not-IMT) group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Francisco Martínez-Arnau, PhD", "role"=>"CONTACT", "email"=>"francisco.m.martinez@uv.es", "phone"=>"+34 963983853", "phoneExt"=>"51227"}], "overallOfficials"=>[{"name"=>"Francisco Miguel Martínez Arnau, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Universitat de Valencia, Spain"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Valencia", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor of Physiotherapy", "investigatorFullName"=>"Francisco Martínez Arnau", "investigatorAffiliation"=>"University of Valencia"}}}}
