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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Female breast cancer survivors aged 40-60 years. 2. diagnosed by tissue sample (biopsy-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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Pilates Exercises

The Pilates program will consist of mat-based exercises with optional use of light equipment such as resistance bands and small weights. Each session will last 60 minutes and will be performed three times per week over a total duration of 12 weeks. The program will follow a structured progression with systematic increases in exercise difficulty, load, and repetitions based on individual tolerance. The intervention will focus on enhancing core control, spinal extension and posture, lower-limb weight-bearing activities, and balance. Sessions will be initially supervised by a trained physiotherapist with expertise in oncology rehabilitation.

DRUG

Calcium and Vitamin D Supplementation

Participants will receive daily oral calcium supplementation at a total dose of 1,200 mg/day, combined with vitamin D (total daily vitamin D dose: 200 IU), administered throughout the study period as part of standard osteoporosis management for breast cancer survivors receiving hormonal therapy.

Locations (1)

Outpatient clinic, faculty of Physical Therapy, Benha university
Banhā, Benha, Egypt