Exercise for body composition and bone health in people with thalassemia

Effect of Aerobic Exercise Paired With Strength Conditioning on Bone Health in Patients With Thalassemia

This program tries a weight-bearing exercise plan to see if it improves muscle mass, lowers body fat, and increases bone density and strength in teens and adults with thalassemia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 40 Years
• Sex: All
• Sponsor: University of California, San Francisco (other)
• Locations: 2 sites (Oakland, California and 1 other locations)
• Trial ID: NCT07064941 on ClinicalTrials.gov

What this trial studies

This interventional protocol enrolls adolescents and adults (age 14–40) with thalassemia and low bone density to compare a period of usual activity with a supervised weight-bearing exercise intervention. Body composition and bone mineral density are measured by DXA, while muscle function and endurance are measured by handgrip strength, sit-to-stand, vertical jump, and the 6-minute walk test. The intervention includes a 12-week program focused on lean mass and function and a longer 36-week, 30-min/day, 5x/week component aimed at changing bone density. Outcomes are analyzed as within-participant changes between the usual-activity period and the exercise periods.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–40 with thalassemia who have a BMD Z-score < -1.0, vitamin D >20 ng/mL, can consent in English, and are not already exercising vigorously.

Not a fit: People who already exercise regularly, are pregnant, have recent long-bone or vertebral fractures, untreated hypogonadism, significant cardiac iron overload, uncontrolled cardiovascular risk, or other conditions affecting bone may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the exercise program could increase lean mass, reduce body fat, improve bone density and muscle strength, and potentially lower fracture risk and improve mobility.

How similar studies have performed: Exercise interventions have improved bone and muscle outcomes in other populations and small reports suggest benefit in thalassemia, but large controlled data in thalassemia remain limited.

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

Where this trial is running

Oakland, California and 1 other locations

• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (RECRUITING)
• University of California, San Francisco — Oakland, California, United States (RECRUITING)

Study contacts

• Principal investigator: Ellen Fung, PhD — University of California, San Francisco
• Study coordinator: Ellen Fung, PhD

Conditions: Thalassemia, Exercise, Body composition, Bone, Muscle function