NCT07064941 · University of California, San Francisco
Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia
What this study is about
The goal of this clinical trial is to determine if a weight bearing exercise intervention can improve body composition and bone health in adolescents and adults with Thalassemia.
View original scientific description
The goal of this clinical trial is to determine if a weight bearing exercise intervention can improve body composition and bone health in adolescents and adults with Thalassemia. The main questions it aims to answer are: * Does participation in a 12-week weight bearing exercise intervention change total body lean mass and percentage body fat (as assessed by DXA) in adolescents and adults with Thalassemia? * Does participation in a 12-week weight bearing exercise intervention change muscle function (assessed by hand grip strength, sit to stand and vertical jump) and endurance (assessed by the 6 minute walk test) in adolescents and adults with Thalassemia? * Does participation in a 36 week weight bearing exercise intervention (30 min/day; 5x/week) change bone mineral density as assessed by DXA in adolescents and adults with Thalassemia? Researchers will compare participants' change in body composition, muscle mass, and muscle function during a "Usual Activity" period (12 weeks) with an exercise intervention (Period 1: 12 weeks) to see if exercise can improve body composition and muscle function. The intervention will then be extended an additional 24 weeks for a total of 36 weeks of exercise (Period 2) to explore the change in bone mineral density between between "Usual Activity" and "Exercise Intervention" (Period 2) in individuals with Thalassemia. During the intervention period, participants will engage in a self-directed exercise regime of either weight bearing aerobic exercise or strength training exercises (30 min/day; 5x/week).
Interventions
BEHAVIORAL
Exercise
Exercise for 30 min a day 5x a week with a choice between Aerobic or strength training. Subjects will choose an aerobic activity to perform 3x/week (e.g. brisk walking, hiking, jogging). They will start at 15-20 min/day depending on fitness level and build up by 5 min intervals/week as tolerated to 50 min/day or 150 min/week by 12 weeks. Subjects will choose strength exercises to perform 2x/week, on days separate from aerobic activity. They will start with 1-2 exercises (e.g. squats, lunges, planks with and without resistance) and gradually add exercises to include all muscle groups (arms, legs, chest, back, abdomen). Start with 2 sets of 10 reps, and work up to 3 sets of 15 reps of given exercises.
Primary outcome measures
Total Body Lean Mass (grams)
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA)
Percentage Body Fat
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 14 - 40 years
- BMD Z-score at any skeletal site \< -1.0
- Diagnosed with thalassemia (any genotype, regardless of transfusion dependency)
- Vitamin D (25-Hydroxy) drawn within the previous 12 months \>20 ng/mL
- English speaking, able to consent
Exclusion criteria
- Patients who self-identify as 'exercisers' e.g. routinely exercise for minimum of 45 min/day, 5x/week
- Pregnant (unable to conduct bone density measurements in pregnant females)
- Hypogonadal, must be on replacement sex hormone therapy for min of 6 months
- Cardiac T2\
- by Magnetic Resonance Imaging of \<20 ms (e.g. evidence of cardiac iron overload)
- Recent long bone or vertebral fracture (within the last 6 months)
- Cognitive impairment limiting ability to understand instructions during orientation
- Other conditions known to influence bone health or body composition as determined by the investigator
- Patients at risk for cardiovascular disease yet have not received a routine cardiology assessment within the previous 12 months
- Bone medication (e.g. Zometa, Prolia, Forteo) use in previous 2 years
Where
- Oakland, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2025 · Source of record for eligibility and locations