[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454196":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":43,"centralContacts":47,"locations":57,"responsibleParty":112,"collaborators":114,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":35,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":148,"overallStatus":60,"whyStopped":35,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Nicotinamide Riboside (NR)","EXPERIMENTAL","Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).\n\nFor individuals with weight \\> 72 kg: 900 mg po qd x 16 wks.\n\nFor individuals with weight \\> 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks.\n\nFor individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks.",[13],"Dietary Supplement: Nicotinamide Riboside",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).\n\nFor individuals with weight \\> 72 kg: 900 mg po qd x 16 wks.\n\nFor individuals with weight \\> 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks.\n\nFor individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks.",[19],"Dietary Supplement: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Exercise Intervention and NR","The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.\n\nParticipants in this arm will receive both the Exercise Intervention and the NR.",[13,24],"Other: Exercise Intervention",{"label":26,"type":10,"description":27,"interventionNames":28},"Exercise Intervention and Placebo","The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.\n\nParticipants in this arm will receive both the Exercise Intervention and the Placebo",[19,24],[30,36,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT","Nicotinamide Riboside","Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).\n\nNR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.\n\nThe dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.",[21,9],null,{"type":31,"name":15,"description":37,"armGroupLabels":38,"otherNames":35},"The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule)",[26,15],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":35},"Exercise Intervention","The exercise program consists of at-home training sessions and will include aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strengthening over 16 weeks. For aerobic training, the eventual intensity and duration goal (adapted for each person as necessary) will be for persons to train at 70-80% of peak 2MSPT heart rate 20-45 minutes 3-5 days\u002Fweek. For resistance exercises the goal will be a load\u002Fweight that results in fatigue after 3 sets of 10-12 repetitions on 8-10 exercises 2 days\u002Fweek.",[21,26],[44],{"name":45,"affiliation":5,"role":46},"Sogol Mostoufi-Moab, MD, MSCE","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":35,"email":52},"Katherine Cambareri, MPH","CONTACT","445-942-7801","cambarerik@chop.edu",{"name":54,"role":50,"phone":55,"phoneExt":35,"email":56},"Kristin Wade","267-398-5761","wadekl@chop.edu",[58,79,95],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"City of Hope Medical Center","RECRUITING","Duarte","California","91010","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-117.97729,34.13945,{"lat":70,"lon":69},[73,77],{"name":74,"role":50,"phone":75,"phoneExt":35,"email":76},"Lanie Lindenfeld, MA, CCRP","626-218-1150","llindenfeld@coh.org",{"name":78,"role":46,"phone":35,"phoneExt":35,"email":35},"Saro H Armenian, DO, MPH",{"facility":5,"status":60,"city":80,"state":81,"zip":82,"country":64,"countryCode":65,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Philadelphia","Pennsylvania","19104",{"type":67,"coordinates":84},[85,86],-75.16362,39.95238,{"lat":86,"lon":85},[89,93,94],{"name":90,"role":50,"phone":91,"phoneExt":35,"email":92},"Susan Lee","267-602-4603","leess@chop.edu",{"name":54,"role":50,"phone":55,"phoneExt":35,"email":56},{"name":45,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":96,"status":60,"city":97,"state":98,"zip":99,"country":64,"countryCode":65,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",{"type":67,"coordinates":101},[102,103],-90.04898,35.14953,{"lat":103,"lon":102},[106,110],{"name":107,"role":50,"phone":108,"phoneExt":35,"email":109},"Sarah Terrell, MS","901-595-4466","sarah.terrell@stjude.org",{"name":111,"role":46,"phone":35,"phoneExt":35,"email":35},"Kirsten K. Ness, PhD",{"type":113,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[115,118,119,120,122],{"name":116,"class":117},"National Institutes of Health (NIH)","NIH",{"name":59,"class":6},{"name":96,"class":6},{"name":121,"class":117},"National Cancer Institute (NCI)",{"name":123,"class":6},"University of Pennsylvania","100454196","phase-2-exercise-training-and-nr-supplementation-trial-to-improve-fitness-in-aya-hct-survivors-100454196",false,"NCT05194397","Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors","Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors","IAMFIT","Inclusion Criteria:\n\n1. Males and females, ages 10-30 years at enrollment\n2. Able to understand and speak English\n3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT\n4. 6-48 months from allogeneic HCT\n5. Females must have a negative urine\u002Fserum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.\n6. Subject's informed consent or parental\u002Fguardian permission (informed consent) and if appropriate, child assent\n7. Minimum weight of 24 kg\n\nExclusion Criteria:\n\n1. Known sensitivity to NR\n2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity\n3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit\n4. Currently meeting public health exercise guidelines\n5. Use of NAD+ precursors (supra-physiologic) within 4 weeks\n6. Hemoglobin \\\u003C 10 g\u002FdL\n7. Platelets \\\u003C 50K\n8. Diabetes Mellitus requiring insulin or insulin secretagogue\n9. HbA1C ≥ 8% or fasting glucose \\> 125 mg\u002FdL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible.\n10. Kidney disease (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2)\n11. Liver disease Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) (ALT\u002FAST \\> 3 x ULN)\n12. Limitations in physical function preventing exercise testing\u002Ftraining\n13. Unstable angina or history of acute myocardial infarction (\\\u003C5 days of planned study procedures)\n14. Recurrent syncope\n15. Symptomatic severe aortic stenosis\n16. Uncontrolled arrhythmia causing symptoms\n17. Pulmonary embolus \\\u003C3 months of study procedures\n18. Thrombosis of lower extremities\n19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing\n20. Room air desaturation at rest ≤85%\n21. Females: Pregnant or planning pregnancy\n22. Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis, \\>moderate Graft versus host disease (GVHD) resulting in physical or functional impairment)\n23. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n24. For MRI procedure: Contraindications to MRI. Individuals will be screened to ensure they can safely complete the MRI. \\*participants who cannot complete the MRI will not be excluded from participation in the remainder of the study procedures if they meet those inclusion and exclusion criteria.\n25. Current weight precludes safe completion of study procedures","ALL","10 Years","30 Years",{"count":136,"type":137},80,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors.\n\nThe primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to 16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity (VO2 max) from baseline to 16 weeks.",[143,144,145,146,147],"Lymphoblastic Leukemia","Cancer Survivors","Aplastic Anemia","Myelodysplastic Syndromes","Myeloid Leukemia",[149,150,40,151,152,153,144,154],"Sarcopenia","NAD+","OXPHOS Capacity","VO2 Max","Adolescent young adults","Hematopoietic Stem Cell Transplantation (HCT)","2025-12-02",{"date":157,"type":158},"2025-12-04","ACTUAL",{"date":160,"type":158},"2023-02-23",{"date":162,"type":137},"2026-06-30",{"name":5,"class":6},3]