Actively Recruiting

Phase Not Applicable
Age: 14Years - 40Years
All Genders
NCT07064941

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

Age: 14Years - 40Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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