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Search / Trial NCT07064941

Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 7, 2025

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Exercise Body Composition Bone Muscle Function

ClinConnect Summary

This clinical trial is studying whether a special exercise program can help improve muscle strength, body makeup, and bone health in teenagers and adults with thalassemia—a blood condition that can affect overall health. The study wants to see if doing weight-bearing exercises (like walking, jumping, or strength training) for about 30 minutes a day, five days a week, over several months can increase muscle mass, reduce body fat, and strengthen bones.

People between 14 and 40 years old who have thalassemia and lower-than-normal bone density might be eligible to join, as long as they don’t already exercise regularly, aren’t pregnant, and meet a few other health-related criteria. Participants will first go through 12 weeks of their usual activity, then 12 weeks of the exercise program, and finally continue the exercise for another 24 weeks. During this time, researchers will check changes in muscle strength, endurance, body composition, and bone density using safe and painless tests. This study aims to find out if exercise can be a helpful way to support bone and muscle health in people living with thalassemia.

Gender

ALL

Eligibility criteria

  • 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

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

Oakland, California, United States

Oakland, California, United States

Patients applied

0 patients applied

Trial Officials

Ellen Fung, PhD

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported