Pilates to improve spine and hip bone density in breast cancer survivors on aromatase inhibitors
Impact of Pilates Exercises on Bone Mineral Density in Breast Cancer Survivors Receiving Hormonal Therapy
NA · Benha University · NCT07334626
This 12-week program will see if supervised Pilates combined with calcium and vitamin D can improve spine and hip bone density in breast cancer survivors taking aromatase inhibitors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Benha University (other) |
| Locations | 1 site (Banhā, Benha) |
| Trial ID | NCT07334626 on ClinicalTrials.gov |
What this trial studies
Sixty female breast cancer survivors aged 40–60 with low bone mineral density and receiving aromatase inhibitor therapy will be enrolled and assigned to a 12-week supervised Pilates program or a comparison group, with both groups receiving calcium and vitamin D supplementation. The Pilates intervention consists of low-to-moderate intensity, clinic-based sessions three times per week focused on core strength, balance, posture, and functional mobility. Bone mineral density at the lumbar spine and hip will be measured by DXA at baseline and after 12 weeks, alongside functional measures related to strength and balance. Participants will be recruited from Benha University outpatient clinics and screened for medical clearance and eligibility prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are women aged 40–60 with stage I–III breast cancer who have been on aromatase inhibitors for at least 3 months and have a T-score ≤ -1.0 at the spine or hip and are medically cleared for low-to-moderate intensity exercise.
Not a fit: Patients with metastatic or recurrent disease, recent osteoporotic fractures, severe cardiopulmonary or musculoskeletal contraindications, or who cannot attend supervised sessions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could offer a low-impact exercise option to slow bone loss and lower fracture risk for breast cancer survivors on hormonal therapy.
How similar studies have performed: Previous Pilates trials in similar populations have improved strength and balance relevant to fracture risk, but randomized evidence showing a clear benefit for bone mineral density is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female breast cancer survivors aged 40-60 years. 2. Histologically confirmed stage I-III breast cancer. 3. Currently receiving hormonal therapy (aromatase inhibitors) for at least 3 months. 4. At risk of osteoporosis or with low bone mineral density (BMD) defined by T-score ≤ -1.0 at lumbar spine or hip. 5. Medically cleared for exercise, specifically low-to-moderate intensity Pilates. 6. Able to attend supervised exercise sessions three times per week for 12 weeks. 7. Willing and able to provide written informed consent. Exclusion Criteria: 1. Metastatic (stage IV) or recurrent breast cancer. 2. History of osteoporotic fractures in the past 12 months. 3. Severe cardiovascular, respiratory, or musculoskeletal conditions that contraindicate exercise. 4. Uncontrolled hypertension, diabetes, or thyroid disorders. 5. Current use of corticosteroids. 6. Active bone metabolic disease other than osteoporosis (e.g., Paget's disease, osteomalacia). 7. Severe cognitive impairment or psychiatric illness preventing adherence to exercise or supplementation. 8. Known allergy or intolerance to calcium or vitamin D supplementation. 9. Participation in another clinical trial with structured exercise or bone-targeted intervention within the last 3 months.
Where this trial is running
Banhā, Benha
- Outpatient clinic, faculty of Physical Therapy, Benha university — Banhā, Benha, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Email: mahmoud.mohamed@fpt.bu.edu.eg
- Phone: 01096968910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Cancer Survivors, Aromatase Inhibitors, Osteoporosis or Osteopenia, Pilates Exercise, pilates exercises, breast cancer survivors, bone mineral denisty