Actively Recruiting
Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia
Led by University of California, San Francisco · Updated on 2025-07-15
20
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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).
CONDITIONS
Official Title
Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 40 years
- Bone mineral density Z-score below -1.0 at any skeletal site
- Diagnosed with Thalassemia of any genotype
- Vitamin D level above 20 ng/mL within the last 12 months
- English speaking and able to provide consent
You will not qualify if you...
- Regular exercisers who work out at least 45 minutes per day, 5 times a week
- Pregnant females
- Hypogonadal patients not on sex hormone replacement therapy for at least 6 months
- Cardiac iron overload with T2* MRI less than 20 ms
- Recent long bone or vertebral fracture within the past 6 months
- Cognitive impairment affecting ability to follow instructions
- Other medical conditions affecting bone health or body composition as judged by the investigator
- Patients at risk for cardiovascular disease without cardiology assessment in past 12 months
- Use of bone medications like Zometa, Prolia, or Forteo in the last 2 years
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
2
University of California, San Francisco
Oakland, California, United States, 94609
Actively Recruiting
Research Team
E
Ellen Fung, PhD
CONTACT
R
Raquel Manzo, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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