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

Part of paid clinical trials in Oakland, California.

Sponsor
University of California, San Francisco
Study ID
NCT07064941
Status
Recruiting
Apply to this trial

Conditions

  • Thalassemia

Eligibility Criteria

Sex
ALL
Age
14 Years - 40 Years
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Dec 1, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Usual Activity
    Subjects will participate in usual daily activities during this period

Primary Outcome Measure

Total Body Lean Mass (grams) [ Time Frame: 12 weeks (Period 1) and 36 weeks (Period 2) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Ellen Fung, PhD
[email protected]
510-428-3885
Raquel Manzo
[email protected]
University of California, San FranciscoOaklandCalifornia94609-

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By research site
UCSF Benioff Children's Hospital Oakland· Oakland, CAUniversity of California, San Francisco· Oakland, CA

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