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NCT Number: NCT07064941

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Motor Activity

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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 outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 6 minute walk test (6MWT)

    Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)

    Distanced walked during a 6MWT

  2. Vertical Jump

    Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)

    Vertical jump from a standing height (cm)

  3. Bone Mineral Density (BMD)

    Time frame: 36 weeks (Period 2)

    Bone mineral density at the spine, left hip, left distal radius and whole body as assessed by Dual Energy X-Ray Absorptiometry (DXA)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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