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

January 14, 2026 updated by: Mahmoud Hamada Mohamed, Benha University
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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Drug: Calcium 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.
Experimental: Study group
Other: Pilates 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.
Drug: Calcium 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire.
Time Frame: 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 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)
Base line and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Collaborators

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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