Thalassemia
Conditions
Keywords
Exercise, Body composition, Bone, Muscle function
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).
Interventions
BEHAVIORALExercise
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.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Lean Mass (grams) | 12 weeks (Period 1) and 36 weeks (Period 2) | Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA) |
| Percentage Body Fat | 12 weeks (Period 1) and 36 weeks (Period 2) | Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test (6MWT) | 12 weeks (Period 1) and 36 weeks (Period 2) | Distanced walked during a 6MWT |
| Vertical Jump | 12 weeks (Period 1) and 36 weeks (Period 2) | Vertical jump from a standing height (cm) |
| Bone Mineral Density (BMD) | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREllen Fung, PhD
University of California, San Francisco
Outcome results
None listed