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RECRUITING

NCT05194397

PHASE2

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

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

10 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-02-23

Completion Date

2026-06-30

Last Updated

2025-12-04

Healthy Volunteers

Conditions

Lymphoblastic Leukemia Cancer Survivors Aplastic Anemia Myelodysplastic Syndromes Myeloid Leukemia

Interventions

DIETARY_SUPPLEMENT

Nicotinamide Riboside

Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules. The 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.

DIETARY_SUPPLEMENT

Placebo

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)

OTHER

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/week. For resistance exercises the goal will be a load/weight that results in fatigue after 3 sets of 10-12 repetitions on 8-10 exercises 2 days/week.

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

Locations (3)

City of Hope Medical Center

Duarte, California, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States