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?

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).

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
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Recruited
19,080,000+
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