RecruitingNot ApplicableNCT07334626

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

Sponsor

Benha University

Enrollment

60 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Survivors Aromatase Inhibitors Osteoporosis or Osteopenia Pilates Exercise

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.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Inclusion Criteria7

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.

Exclusion Criteria9

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.

Interventions

OTHERPilates 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.

DRUGCalcium 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.