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).
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
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)
Single group
Exercise
BehavioralExercise 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.
Total Body Lean Mass (grams)
Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA)
Percentage Body Fat
Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA)
6 minute walk test (6MWT)
Distanced walked during a 6MWT
Vertical Jump
Vertical jump from a standing height (cm)
Bone Mineral Density (BMD)
Bone mineral density at the spine, left hip, left distal radius and whole body as assessed by Dual Energy X-Ray Absorptiometry (DXA)
Click on the lead sponsor to view all of their trials.
