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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Aromatase Inhibitors; Breast Cancer Survivors; Osteoporosis or Osteopenia; Pilates Exercise
• Intervention / Treatment: Other: Pilates Exercises; Drug: Calcium and Vitamin D Supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 11603
      • Outpatient clinic, faculty of Physical Therapy, Benha university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Drug: Calcium and Vitamin D Supplementation; 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.
Experimental: Study group	Other: Pilates 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; Drug: Calcium and Vitamin D Supplementation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density (BMD) measurement	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.	Base line and after 12 weeks

Secondary Outcome Measures

Outcome Measure	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 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)	Base line and after 12 weeks

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): July 20, 2026
• Study Completion (Actual): July 20, 2026

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: aromatase inhibitors; breast cancer survivors; pilates exercises; bone mineral denisty
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Metabolic Diseases; Skin Diseases; Breast Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Osteoporosis; Bone Diseases, Metabolic; Therapeutics; Biological Factors; Physical Therapy Modalities; Inorganic Chemicals; Elements; Metals; Blood Coagulation Factors; Metals, Alkaline Earth; Calcium; Exercise Movement Techniques
• Other Study ID Numbers: Pilates on osteoporosis BCS26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No