Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia (NCT07064941) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia
United States20 participantsStarted 2024-12-01
Plain-language 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).
Who can participate
Age range
14 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Body Lean Mass (grams)
Timeframe: 12 weeks (Period 1) and 36 weeks (Period 2)
2
Percentage Body Fat
Timeframe: 12 weeks (Period 1) and 36 weeks (Period 2)