Aromatase Inhibitors, Breast Cancer, Breast Cancer Survivors, Osteoporosis or Osteopenia, Pilates Exercise
Conditions
Keywords
pilates exercises, breast cancer survivors, bone mineral denisty, aromatase inhibitors
Brief summary
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.
Detailed 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.
Interventions
OTHERPilates Exercises
Pilates Exercise Program: Participants completed a supervised Pilates exercise program three times weekly for 12 consecutive weeks. Each 60-minute session was delivered by a certified physiotherapist experienced in oncology rehabilitation and consisted of a 10-minute warm-up, 40-minute progressive mat-based Pilates training, and 10-minute cool-down. The program emphasized breathing control, core stabilization, postural alignment, precision, and coordinated movement. Exercises targeted the trunk, pelvic floor, spinal extensors, hip stabilizers, and lower-extremity muscles and included pelvic tilts, abdominal drawing-in, modified Hundred, Single- and Double-Leg Stretch, Shoulder Bridge, Spine Stretch Forward, modified Swimming, Side Leg Series, Clam, Bird Dog, and Wall Squats. Exercises were generally performed in 2 sets of 10-15 repetitions with 5-10-second isometric holds and 30-60-second rest intervals. Exercise intensity and progression were individualized and advanced every two week
Participants received oral calcium (1,200 mg/day) and vitamin D (1,000 IU/day) throughout the 12-week study as standard supportive care for aromatase inhibitor-associated bone loss. Supplementation was prescribed by the treating oncologist before enrollment and continued unchanged during the study.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density (BMD) measurement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. | Base line and after 12 weeks | 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 were calculated according to standardized scoring guidelines, with higher scores indicating better quality of life. Participants completed the questionnaire at baseline (pre-intervention) and at 12 weeks (post-intervention) |
Countries
Egypt
Outcome results
None listed