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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental |
| |
| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilates Exercises | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density (BMD) measurement | Change in bone mineral density (BMD) at the lumbar spine and total hip (g/cm²) from baseline to 12 weeks. BMD will be measured using dual-energy X-ray absorptiometry (DEXA), which is the standard technique for assessing BMD at the lumbar spine and proximal femur. The BMD and T-score of the femoral neck and lumbar vertebrae will be determined using a Hologic Discovery W series DEXA scanner. | Base line and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. | Change in health-related quality of life (HRQoL) from baseline to 12 weeks, assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. The FACT-B is a validated, self-administered instrument that evaluates five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns. Scores for each domain and the total FACT-B score will be calculated according to standardized scoring guidelines, with higher scores indicating better quality of life. Participants will complete the questionnaire at baseline (pre-intervention) and at 12 weeks (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Hamada Mohamed Associate Professor, Ph.D | Contact | 01096968910 | mahmoud.mohamed@fpt.bu.edu.eg | |
| Ahmed Mounir Salama Associate Professor, Ph.D | Contact | ahmed.moumir@fpt.bu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic, faculty of Physical Therapy, Benha university | Recruiting | Banhā | Benha | 11603 | Egypt |
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Single (Participant) This is a parallel group randomized controlled trial with two arms receiving different interventions
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| Calcium and Vitamin D Supplementation | Drug | 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. |
|
| Base line and after 12 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D026241 | Exercise Movement Techniques |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
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