[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617952":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":12,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Observation cohort","NO_INTERVENTION","These participants did not have early signs of sarcopenia at the post induction therapy assessment point, but will be followed up at all timepoints to better understand the natural progression of acute lymphoblastic leukaemia.\n\nUsual care is a ward based physiotherapist service which is reactive and referral based only.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Usual care control group","These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the control group. Usual care is a ward based physiotherapist service which is reactive and referral based only.",{"label":17,"type":18,"description":19,"interventionNames":20},"Intervention group","EXPERIMENTAL","These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the intervention group. The intervention group receives 9 weeks of goal setting and physical activity behaviour change coaching, as well as concurrently receiving 8 weeks of structured exercise sessions weekly (45-60 minutes per session x 3\u002Fweek). These sessions are individualised based on the participant's functional performance outcomes from the assessment prior to randomisation, with a resistance strength training and progressive overload principles. The delivery of the specific exercises will be based on a pragmatic, participation based focus and will incorporate the individual's development stage, age, interests and enjoyment.",[21],"Behavioral: Exercise",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Exercise","These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the intervention group. The intervention group receives 9 weeks of goal setting and physical activity behaviour change coaching (with activity tracking via Fitbit for continuous feedback) as well as concurrent 8 weeks of 3x45-60 minute structured exercise sessions weekly. These are individualised based on their functional performance outcomes from the assessment prior to randomisation with a resistance strength training and progressive overload principles. The delivery of the specific exercises will be based on a pragmatic, participation based focus and will incorporate the individuals development stage, age, interests and enjoyment.",[17],[29,30,31],"physical activity","behaviour change","wearable device",[33],{"name":34,"affiliation":35,"role":36},"Rachel Conyers, A\u002FProf Paediatric Oncologist","Murdoch Children's Research Institute, Royal Children's Hospital (Melbourne), University of Melbourne","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},"Sarah Grimshaw, PhD Physiotherapy","CONTACT","+61417162166","sarah.grimshaw@mcri.edu.au",{"name":44,"role":40,"phone":45,"phoneExt":12,"email":46},"Ella Thorburn, Bachelor of Physiotherapy(hon)","+61415066889","ella.thorburn@student.unimelb.edu.au",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Royal Children's Hospital","RECRUITING","Melbourne","Victoria","3052","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],144.96332,-37.814,{"lat":60,"lon":59},[63,64,65],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},{"name":44,"role":40,"phone":45,"phoneExt":12,"email":46},{"name":39,"role":66,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100617952","physical-activity-and-exercise-during-early-treatment-phases-for-childhood-acute-lymphoblastic-leukaemia-to-protect-against-muscle-loss-and-improve-frailty-outcomes-100617952",false,"NCT07325305","Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes","The PROTECT Trial Physical Activity and Exercise During Early Treatment for Children With Acute Lymphoblastic Leukaemia to Protect Against Sarcopenia and Improve Frailty Outcomes: a Pilot Randomised Controlled Trial","PROTECT","Inclusion Criteria:\n\n* Aged 5-17 years at the time of consent\n* New diagnosis of acute lymphoblastic leukaemia \\\u003C7 days\n* Is planned to receive management for their cancer treatment at the trial site for the duration of the trial period\n* Has a legally acceptable representative capable of understanding the informed consent document in English and providing consent on the participant's behalf\n* Have a family electronic device that can be linked with the tool to be used (Fitbit)\n\nExclusion Criteria:\n\n* none","ALL","5 Years","17 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85],"NA","This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children\u002Fadolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty.\n\nKids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do.\n\nThe goal:\n\nTo see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back\u002Fmaintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.",[88,89],"Sarcopenia","Acute Lymphoblastic Leukemia",[91,29,30,92],"exercise","paediatrics","2026-04-08",{"date":95,"type":96},"2026-04-13","ACTUAL",{"date":98,"type":96},"2026-02-24",{"date":100,"type":82},"2028-10",{"name":5,"class":6},1]