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

NCT07064941 | Recruiting

• 1 other identifier: Thal Exercise
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Thalassemia

Keywords

Exercise; Body composition; Bone; Muscle function

Outcome Measures

Primary Outcomes (2)

• Total Body Lean Mass (grams)

  Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA)

  12 weeks (Period 1) and 36 weeks (Period 2)

• Percentage Body Fat

  Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA)

  12 weeks (Period 1) and 36 weeks (Period 2)

Secondary Outcomes (3)

• 6 minute walk test (6MWT)

  12 weeks (Period 1) and 36 weeks (Period 2)

• Vertical Jump

  12 weeks (Period 1) and 36 weeks (Period 2)

• Bone Mineral Density (BMD)

  36 weeks (Period 2)

Study Arms (1)

Usual Activity

OTHER

Subjects will participate in usual daily activities during this period

Behavioral: Exercise

Interventions

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.

Usual Activity

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

RECRUITING

University of California, San Francisco

Oakland, California, 94609, United States

RECRUITING

MeSH Terms

Conditions

Thalassemia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ellen Fung, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Fung, PhD

CONTACT

510-428-3885; ellen.fung@ucsf.edu

Raquel Manzo, BS

CONTACT

510-428-3429; raquel.manzo@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a delayed start interventional study where subjects serve as their own controls. Each subject will first participate in a 12 week usual care period in which they will not change their activity, followed by a 12 week exercise intervention (Period 1) and end with an additional 24 weeks of the exercise intervention (Period 2).

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)