Nctid:
NCT06223776
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Rare Diseases", "abbrev"=>"Rare"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["CARE_PROVIDER"]}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2023-05-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-08-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-10", "studyFirstSubmitDate"=>"2023-11-10", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-11", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Objective Sleep - Total sleep time", "timeFrame"=>"1 day after night with or without intervention", "description"=>"Total sleep time obtained from sleep onset to time at wake-up assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Objective Sleep - Sleep efficiency", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"The percentage of total sleep time to lights off and leaving bed assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Objective Sleep - WASO (Wake After Sleep Onset)", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"The total number of minutes that a person is awake after having initially fallen asleep assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Objective Sleep - Sleep duration", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"The quantity of time that a person sleeps assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Objective Sleep - Sleep onset time", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"The time it takes a person to fall asleep after turning the lights out assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Objective Sleep - Wake time", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"The hours in the day that a person is awake assessed by actigraphy. The night before and after the experimental sessions."}, {"measure"=>"Blood collection - progesterone", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"Blood will be drawn to measure progesterone. Before each experimental sesion"}, {"measure"=>"Blood collection - estradiol", "timeFrame"=>"1 day after night with or without intervention.", "description"=>"Blood will be drawn to measure estradiol. Before each experimental sesion"}], "primaryOutcomes"=>[{"measure"=>"Maximal strength bench press test", "timeFrame"=>"1 day after night with or without intervention", "description"=>"The next day after a) sleep restriction b) normal sleep"}, {"measure"=>"Muscle endurance test in bench press", "timeFrame"=>"1 day after night with or without intervention", "description"=>"muscle endurance test in the bench press exercise at 50% 1RM"}, {"measure"=>"Explosive bench press exercise", "timeFrame"=>"1 day after night with or without intervention", "description"=>"three sets of three repetitions of explosive bench press exercise at 50% of the load representing one-repetition maximum (1RM)"}, {"measure"=>"Countermovement jump", "timeFrame"=>"1 day after night with or without intervention", "description"=>"Vertical jump test performed by having an athlete quickly squat to a self-selected depth and then jump as high as possible."}], "secondaryOutcomes"=>[{"measure"=>"Mood (POMS)", "timeFrame"=>"1 day after night with or without intervention", "description"=>"The POMS is a widely-applied measure for the assessment of an individual's mood. During each experimental session. Before sports performance protocol."}, {"measure"=>"Pain (Pain scale)", "timeFrame"=>"1 day after night with or without intervention", "description"=>"A pain scale is a tool use to help assess a person's pain. Scale 0-10 (0- lack of pain; 10 - maximal pain). Immediately after the last performance exercise in experimental sessions."}, {"measure"=>"Motivation", "timeFrame"=>"1 day after night with or without intervention", "description"=>"During each experimental session. Before sports performance protocol."}, {"measure"=>"Rating perceived exertion (RPE)", "timeFrame"=>"1 day after night with or without intervention", "description"=>"A subjective scale that assesses the severity of effort exerted. Includes a rating from 6 perceiving \"no effort\" to 20 perceiving \"maximum effort.\" Immediately after the last performance exercise in experimental sessions."}, {"measure"=>"Stress and recovery (SRSS)", "timeFrame"=>"1 day after night with or without intervention", "description"=>"The Short Recovery and Stress Scale (SRSS) measure the recovery-stress state of an athlete multidimensionally with eight items on emotional, mental, physical, and overall levels. In the morning, each experimental day and the day after."}, {"measure"=>"Readiness-to-train questionnaire (RTT-Q)", "timeFrame"=>"1 day after night with or without intervention", "description"=>"Subjective reactions related to the level of motivation for effort. In the morning, each experimental day and the day after."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["acute sleep restriction", "early sleep restriction"], "conditions"=>["Sleep Restriction", "Sleep"]}, "descriptionModule"=>{"briefSummary"=>"The study aims to see how acute sleep restriction will affect women resistance trainers. Above all, the investigators will be interested in observing the relationship between shorter sleep and athletic performance, as well as other important aspects, such as their level of motivation to exercise, how much pain participants felt during exercise and how demanding they found exercise. The investigators assume that differences in subjective measures (such as pain levels, motivation and mood) will be most apparent.", "detailedDescription"=>"Participants would take part in two identical experimental sessions under two sleep conditions:\n\nwith sleep restrictions (SR), where will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep); with the control condition (CON), where participants will follow their habitual sleep-wake routines.\n\nEvery session would separated by a 1-week interval. The average sleep duration (CON) is going to be estimated by using actigraphy Motionwatch 8 for 5 days (from Monday to Friday).\n\nFemale athletes will receive accelerometers one day before experimental sessions. Participants will be asked to wear them on their non-dominant wrists from 8 p.m. to the next morning (experimental sessions day).\n\nThe participants would complete the morning session with a battery of physical tests, measuring several components of specific physical performance capacity and cognitive function.\n\nDuring the experimental sessions, participants would be at the luteal or follicular phases excluding the period of bleeding (4-5 days) and the time immediately before planned bleeding (3 days before), because this can have a bad influence on sleep."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"30 years", "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* a minimum of 3 years of training experience;\n* practicing physical activity for the last 6 months at least 3 times per week for 2h\n* current medical qualification for competitive sport\n\nExclusion Criteria:\n\n* diseases that can have a bad influence on the menstrual cycle (e.g. polycystic ovarian syndrome, endometriosis);\n* using hormonal contraception;\n* regularity of the menstrual cycle.\n* diagnosed cardiovascular, metabolic, gastrointestinal, or neurological diseases;\n* movement, neuromuscular or musculoskeletal disorders;\n* taking medications and supplements that may affect fitness test results;\n* taking supplements that may affect biochemical test results\n* sleep disorders\n* PSQI \\>5"}, "identificationModule"=>{"nctId"=>"NCT06223776", "briefTitle"=>"Effects of Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.", "organization"=>{"class"=>"OTHER", "fullName"=>"University School of Physical Education, Krakow, Poland"}, "officialTitle"=>"Effects of One Night's Acute Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.", "orgStudyIdInfo"=>{"id"=>"160/MN/INoS/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Normal sleep", "description"=>"The night before the experimental session, where participants will follow their habitual sleep-wake routines."}, {"type"=>"EXPERIMENTAL", "label"=>"Sleep restriction", "description"=>"The night before the experimental session (with sleep restrictions (SR)), where participants will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep).", "interventionNames"=>["Procedure: Sleep restriction"]}], "interventions"=>[{"name"=>"Sleep restriction", "type"=>"PROCEDURE", "description"=>"Participants will experience a night of acute sleep restriction. During this night, they will sleep 3 hours less than usual.", "armGroupLabels"=>["Sleep restriction"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31-571", "city"=>"Kraków", "country"=>"Poland", "facility"=>"University School of Physical Education in Cracow", "geoPoint"=>{"lat"=>50.06143, "lon"=>19.93658}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University School of Physical Education, Krakow, Poland", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
