Impact of Pilates Exercises on Bone Mineral Density in Breast Cancer Survivors Receiving Hormonal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone mineral density (BMD) measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physiotherapists and participants were not blind to group allocation, given the study nature (exercise). However, the physiotherapist who administered the HRQoL assessment remained blinded throughout the study, and participants were instructed not to disclose their treatment during assessment. BMD measurements were performed and interpreted independently by a certified radiologist blinded to treatment group, according to the standard DEXA protocol. Statistical analyses were conducted using coded datasets, with treatment allocation concealed throughout all analyses.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivors aged 40-60 years.
- •Histologically confirmed stage I-III breast cancer.
- •Currently receiving hormonal therapy (aromatase inhibitors) for at least 3 months.
- •At risk of osteoporosis or with low bone mineral density (BMD) defined by T-score ≤ -1.0 at lumbar spine or hip.
- •Medically cleared for exercise, specifically low-to-moderate intensity Pilates.
- •Able to attend supervised exercise sessions three times per week for 12 weeks.
- •Willing and able to provide written informed consent.
排除标准
- •Metastatic (stage IV) or recurrent breast cancer.
- •History of osteoporotic fractures in the past 12 months.
- •Severe cardiovascular, respiratory, or musculoskeletal conditions that contraindicate exercise.
- •Uncontrolled hypertension, diabetes, or thyroid disorders.
- •Current use of corticosteroids.
- •Active bone metabolic disease other than osteoporosis (e.g., Paget's disease, osteomalacia).
- •Severe cognitive impairment or psychiatric illness preventing adherence to exercise or supplementation.
- •Known allergy or intolerance to calcium or vitamin D supplementation.
- •Participation in another clinical trial with structured exercise or bone-targeted intervention within the last 3 months.
研究组 & 干预措施
Study group
干预措施: Pilates Exercises (Other)
Study group
干预措施: Calcium and Vitamin D Supplementation (Drug)
Control group
干预措施: Calcium and Vitamin D Supplementation (Drug)
结局指标
主要结局
Bone mineral density (BMD) measurement
时间窗: Base line and after 12 weeks
Bone mineral density (BMD; g/cm²) of the lumbar spine (L1-L4) and total hip, measured by dual-energy X-ray absorptiometry (DEXA; Hologic Discovery W Series), which is the standard technique for assessing BMD at the lumbar spine and total hip.
次要结局
- Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire.(Base line and after 12 weeks)
研究者
Mahmoud Hamada Mohamed
Associate Professor of Physical Therapy
Benha University