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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Activity | Other | Subjects will participate in usual daily activities during this period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test (6MWT) | Distanced walked during a 6MWT | 12 weeks (Period 1) and 36 weeks (Period 2) |
| Vertical Jump | Vertical jump from a standing height (cm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Fung, PhD | Contact | 510-428-3885 | 4939 | ellen.fung@ucsf.edu |
| Raquel Manzo, BS | Contact | 510-428-3429 | raquel.manzo@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ellen Fung, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital Oakland | Recruiting | Oakland | California | 94609 | United States |
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| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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).
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|
| 12 weeks (Period 1) and 36 weeks (Period 2) |
| 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) | 36 weeks (Period 2) |
| University of California, San Francisco | Recruiting | Oakland | California | 94609 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |