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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 30 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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. The 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. Males and females, ages 10-30 years at enrollment 2. Able to understand and speak English 3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT 4. 6-48 months from allogeneic HCT 5. Females must have a negative urine/serum 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. 6. Subject's informed consent or parental/guardian permission (informed consent) and if appropriate, child assent 7. Minimum weight of 24 kg Exclusion Criteria: 1. Known sensitivity to NR 2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity 3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit 4. Currently meeting public health exercise guidelines 5. Use of NAD+ precursors (supra-physiologic) within 4 weeks 6. Hemoglobin \< 10 g/dL 7. Platelets \< 50K 8. Diabetes Mellitus requiring insulin or insulin secretagogue 9. HbA1C ≥ 8% or fasting glucose \> 125 mg/dL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible. 10. Kidney disease (eGFR \< 60 ml/min/1.73 m2) 11. Liver disease Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) (ALT/AST \> 3 x ULN) 12. Limitations in physical function preventing exercise testing/training 13. Unstable angina or history of acute myocardial infarction (\<5 days of planned study procedures) 14. Recurrent syncope 15. Symptomatic severe aortic stenosis 16. Uncontrolled arrhythmia causing symptoms 17. Pulmonary embolus \<3 months of study procedures 18. Thrombosis of lower extremities 19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing 20. Room air desaturation at rest ≤85% 21. Females: Pregnant or planning pregnancy 22. 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) 23. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 24. 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. 25. Current weight precludes safe completion of study procedures

Study sites (3)

CA

PA

TN