ThalassemiaNCT07064941
Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia
A study testing Exercise in people with Thalassemia, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Thalassemia
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
University of California, San Francisco
Oakland, California, 94609
About this study
Official title: Effect of Aerobic Exercise Paired With Strength Conditioning on Bone Health in Patients With Thalassemia
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:
Read more
- 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).
- Conditions
- Thalassemia
- Being tested
- Exercise
- Keywords
- Exercise, Body composition, Bone, Muscle function
- Medical subject headings
- Thalassemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Activity | Other | Subjects will participate in usual daily activities during this period Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Lean Mass (grams)
Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA)
Measured: 12 weeks (Period 1) and 36 weeks (Period 2)
Percentage Body Fat
Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA)
Measured: 12 weeks (Period 1) and 36 weeks (Period 2)
Secondary outcomes (3)
6 minute walk test (6MWT)
Distanced walked during a 6MWT
Measured: 12 weeks (Period 1) and 36 weeks (Period 2)
Vertical Jump
Vertical jump from a standing height (cm)
Measured: 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)
Measured: 36 weeks (Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Fung, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064941
- Sponsor's protocol ID
- Thal Exercise
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Paired With Strength Conditioning on Bone Health in Patients With Thalassemia
- ClinicalTrials.gov ID
- NCT07064941
- Acronym / sponsor ID
- Thal Exercise
- Conditions
- Thalassemia
- Keywords
- Exercise, Body composition, Bone, Muscle function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Usual Activity | Other | Behavioral: ExerciseSubjects will participate in usual daily activities during this period |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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. | Behavioural | Usual Activity |
Primary outcome
Total Body Lean Mass (grams)
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Total body lean mass assessed by Dual Energy X-Ray Absorptiometry (DXA)
Percentage Body Fat
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Percentage body fat assessed by Dual Energy X-Ray Absorptiometry (DXA)
3 secondary outcomes
6 minute walk test (6MWT)
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Vertical Jump
Time frame: 12 weeks (Period 1) and 36 weeks (Period 2)
Bone Mineral Density (BMD)
Time frame: 36 weeks (Period 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Fung, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Thalassemia, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Lean Mass (grams) (time frame: 12 weeks (Period 1) and 36 weeks (Period 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.