Actively Recruiting
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
Led by Children's Hospital of Philadelphia · Updated on 2025-12-04
80
Participants Needed
3
Research Sites
174 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 10 to 30 years at enrollment
- Able to understand and speak English
- Diagnosis of leukemia (myeloid or lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT
- Between 6 and 48 months since allogeneic HCT
- Females must have a negative pregnancy test and use acceptable contraception during the study
- Informed consent or parental/guardian permission and child assent if appropriate
- Minimum weight of 24 kg
You will not qualify if you...
- Known sensitivity to nicotinamide riboside (NR)
- Concurrent use of medications that increase risk of NR toxicity, including statins
- Active cancer, investigational agents within 4 weeks, or high-dose glucocorticoids at baseline
- Currently meeting public health exercise guidelines
- Use of NAD+ precursors at high doses within 4 weeks
- Hemoglobin below 10 g/dL
- Platelet count below 50,000
- Diabetes requiring insulin or secretagogues
- HbA1C 8% or higher or fasting glucose over 125 mg/dL (both must be met if diabetic)
- Kidney disease with low eGFR below 60 ml/min/1.73 m2
- Liver disease with ALT or AST levels over 3 times normal
- Physical limitations preventing exercise testing or training
- Recent unstable angina or heart attack within 5 days
- Recurrent fainting
- Severe aortic stenosis symptoms
- Uncontrolled arrhythmia causing symptoms
- Pulmonary embolus within 3 months
- Blood clots in lower limbs
- Moderate or severe persistent asthma
- Low oxygen saturation at rest below 85%
- Pregnant or planning pregnancy
- Non-cardiopulmonary disorders affecting exercise or aggravated by it
- Possible non-compliance with study procedures
- MRI contraindications (those who cannot do MRI may still participate in other parts)
- Weight that prevents safe study procedures completion
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
K
Katherine Cambareri, MPH
CONTACT
K
Kristin Wade
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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