Impact of Pilates Exercises on Bone Mineral Density in Breast Cancer Survivors Receiving Hormonal Therapy (PilatesBCS2026)

Benha University

Status: Enrolling

Conditions: Breast Cancer; Aromatase Inhibitors; Breast Cancer Survivors; Pilates Exercise; Osteoporosis or Osteopenia

Treatments: Drug: Calcium and Vitamin D Supplementation; Other: Pilates Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07334626

Pilates on osteoporosis BCS26

Details and patient eligibility

About

Breast cancer survivors receiving endocrine (hormonal) therapy (aromatase inhibitors) are at high risk for cancer treatment-induced bone loss and osteoporosis due to estrogen depletion.

Full description

Pilates is a safe, low-impact exercise approach that may help manage osteoporosis in breast cancer survivors by improving postural control, core strength, balance, and functional mobility. When appropriately modified, Pilates supports musculoskeletal health, reduces fall risk, and promotes safe movement patterns, making it a suitable intervention for osteoporosis-focused clinical trials in this population.

Guidelines recommend weight-bearing and resistance exercise to slow bone loss, but no RCT has specifically tested Pilates for bone health outcomes in this population.

Existing trials have shown Pilates improves strength and balance, which are relevant for fracture risk, but bone mineral density (BMD) has not yet been clearly evaluated The aim of this study is to evaluate the effect of a 12-weeks Pilates program on bone mineral density (BMD) at the lumbar spine and hip in breast cancer survivors on hormonal therapy.

A total of 60 patients (n=30 per group). Breast cancer survivors receiving endocrine (hormonal) therapy ( aromatase inhibitors) in the past 3 months. Participants will be recruited from Benha University hospital and local oncology clinics in benha. Participants will be screened for eligibility prior to being enrolled in the study participating in the study assessments.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Study group

Experimental group

Treatment:

Other: Pilates Exercises

Drug: Calcium and Vitamin D Supplementation

Control group

Active Comparator group

Treatment:

Drug: Calcium and Vitamin D Supplementation