20 Participants Needed

Exercise for Thalassemia

Recruiting at 1 trial location
EF
RM
Overseen ByRaquel Manzo, BS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a regular routine of weight-bearing exercise can improve body composition and bone health in people with thalassemia, a blood disorder. The researchers aim to determine if exercise can increase muscle mass, reduce body fat, and strengthen bones over time. Participants will initially maintain their normal activities and then switch to an exercise program to compare changes. Suitable candidates are those aged 14 to 40 with thalassemia and lower bone density (indicated by a BMD Z-score less than -1.0) who do not already exercise regularly. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can benefit individuals with thalassemia.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking bone medications like Zometa, Prolia, or Forteo, you must not have used them in the past 2 years to participate.

What prior data suggests that this exercise intervention is safe for individuals with Thalassemia?

Research has shown that weight-bearing exercise is generally safe for people with Thalassemia. These exercises help strengthen bones by improving bone mineral density, benefiting bone health. They pose a low risk and can help manage common bone problems in Thalassemia, such as weaker bones (osteopenia) and brittle bones (osteoporosis).

One study found that physical activity was linked to stronger bones in adults with Thalassemia. Another study showed that weight-bearing exercises increased bone strength in children with Thalassemia. These exercises provide a safe way to support bone health without major side effects.12345

Why are researchers excited about this trial?

Unlike traditional treatments for thalassemia, which often focus on blood transfusions and iron chelation therapy, weight-bearing exercise offers a non-invasive approach that could improve bone health and overall physical well-being. Researchers are excited about this method because it taps into the body's natural ability to strengthen bones through regular physical activity, potentially reducing some of the complications associated with thalassemia. This exercise regimen could complement existing treatments by enhancing patients' quality of life and providing a holistic way to manage the condition.

What evidence suggests that weight bearing exercise might be an effective treatment for Thalassemia?

Research has shown that exercise can benefit people with thalassemia, a blood disorder. Studies have found that increased activity may improve bone health and reduce pain for these patients. In animal studies, endurance exercise strengthened bones and reduced breakdown. One study found that regular exercise, combined with medication and blood transfusions, improved the lives of people with beta-thalassemia. Additionally, in a test where children with thalassemia walked for six minutes, they walked farther after regular exercise, demonstrating better physical fitness. Overall, these findings suggest exercise could enhance body composition, muscle function, and bone health in individuals with thalassemia. Participants in this trial will engage in weight-bearing exercises to further explore these benefits.15678

Who Is on the Research Team?

EF

Ellen Fung, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with Thalassemia who are interested in how exercise affects their body composition and bone health. Participants will engage in a self-directed, weight-bearing exercise program to see if it improves muscle mass, strength, endurance, and bone density.

Inclusion Criteria

BMD Z-score at any skeletal site < -1.0
Vitamin D (25-Hydroxy) drawn within the previous 12 months >20 ng/mL
I am between 14 and 40 years old.
See 2 more

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)
Cardiac T2* by Magnetic Resonance Imaging of <20 ms (e.g. evidence of cardiac iron overload)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Activity

Participants engage in their usual daily activities to establish baseline body composition and muscle function

12 weeks

Exercise Intervention Period 1

Participants engage in a 12-week weight bearing exercise intervention to improve body composition and muscle function

12 weeks
Self-directed exercise (30 min/day; 5x/week)

Exercise Intervention Period 2

Participants continue the exercise intervention for an additional 24 weeks to assess changes in bone mineral density

24 weeks
Self-directed exercise (30 min/day; 5x/week)

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Weight Bearing Exercise
Trial Overview The study tests whether a 12-week weight bearing exercise regimen can change body lean mass and fat percentage, muscle function, and endurance in individuals with Thalassemia. It also examines the impact of extending the intervention to 36 weeks on bone mineral density.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Usual ActivityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Relationships among Physical Activity, Pain, and Bone ...Studies focused on increasing physical activity may contribute to improved bone health and reduced pain in patients with Thal. Keywords: ...
Mild-intensity physical activity prevents cardiac and ...In thalassemic animals, endurance exercise was found to improve bone microstructure by enhancing bone formation and suppressing bone resorption.
Effects of Aquatic Exercise on Dimensions of Quality of Life ...Conclusions: The use of a regular exercise program combined with drug therapy and blood transfusion can be useful in the treatment of beta-thalassemia patients.
Physical Fitness in Children with Thalassemia Major...The outcome measure used in this study was 6-min walk test (6 MWT). Results: The mean distance covered in 6 min was 351.3 m on average. There was increase in ...
(PDF) The Effects of Nutrition, Exercise, and a Praying ...Results The results showed that the mean level of serum ferritin significantly decreased in the intervention group two months after beginning ...
Osteoporosis Prevention Exercise Effects to Bone Density ...Weight-bearing exercise will increase the. BMD in people of all age ... The data revealed that practicing OPE can increase BMD in children with ...
a potential risk factor for osteopenia and osteoporosisCalcium and vitamin D supplementation, as well as weight-bearing exercise, also remain low-risk management options with likely benefit to bone ...
LIFESTYLE AND QUALITY OF LIFE - NCBI - NIHSerious consequences include short stature, bone deformities, delayed puberty, and a varied pathology which can interfere with daily activities and life ...
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