Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors

Description

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.

Conditions

Lymphoblastic Leukemia, Cancer Survivors, Aplastic Anemia, Myelodysplastic Syndromes, Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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.

Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors

Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors

Condition
Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Memphis

St. Jude Children's Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, 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. Parental/guardian permission (informed consent) and if appropriate, child assent
  • 7. Minimum weight of 24 kg
  • 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 guidelines1
  • 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.

Ages Eligible for Study

10 Years to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Sogol Mostoufi-Moab, MD, MSCE, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2026-06-30