RECRUITING

Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Effect of Aerobic Exercise Paired With Strength Conditioning on Bone Health in Patients With Thalassemia

Quick Facts

Study Start:2024-12-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07064941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 14 - 40 years
  2. * BMD Z-score at any skeletal site \< -1.0
  3. * Diagnosed with thalassemia (any genotype, regardless of transfusion dependency)
  4. * Vitamin D (25-Hydroxy) drawn within the previous 12 months \>20 ng/mL
  5. * English speaking, able to consent
  1. * Patients who self-identify as 'exercisers' e.g. routinely exercise for minimum of 45 min/day, 5x/week
  2. * Pregnant (unable to conduct bone density measurements in pregnant females)
  3. * Hypogonadal, must be on replacement sex hormone therapy for min of 6 months
  4. * Cardiac T2\* by Magnetic Resonance Imaging of \<20 ms (e.g. evidence of cardiac iron overload)
  5. * Recent long bone or vertebral fracture (within the last 6 months)
  6. * Cognitive impairment limiting ability to understand instructions during orientation
  7. * Other conditions known to influence bone health or body composition as determined by the investigator
  8. * Patients at risk for cardiovascular disease yet have not received a routine cardiology assessment within the previous 12 months
  9. * Bone medication (e.g. Zometa, Prolia, Forteo) use in previous 2 years

Contacts and Locations

Study Contact

Ellen Fung, PhD
CONTACT
510-428-3885
ellen.fung@ucsf.edu
Raquel Manzo, BS
CONTACT
510-428-3429
raquel.manzo@ucsf.edu

Principal Investigator

Ellen Fung, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
United States
University of California, San Francisco
Oakland, California, 94609
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Ellen Fung, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Exercise
  • Body composition
  • Bone
  • Muscle function

Additional Relevant MeSH Terms

  • Thalassemia