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

NCT ID: NCT07334626

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Group Type: EXPERIMENTAL

Pilates Exercises

Intervention Type: OTHER

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.

Calcium and Vitamin D Supplementation

Intervention Type: DRUG

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.

Control group

Group Type: ACTIVE_COMPARATOR

Calcium and Vitamin D Supplementation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hamada Mohamed

Associate Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

Role: CONTACT

mahmoud.mohamed@fpt.bu.edu.eg

01096968910

Ahmed Mounir Salama Associate Professor, Ph.D

Role: CONTACT

ahmed.moumir@fpt.bu.edu.eg

Facility Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

Role: primary

mahmoud.mohamed@fpt.bu.edu.eg

01096968910

Ahmed Mounir Salama Associate Professor, Ph.D

Role: backup

ahmed.moumir@fpt.bu.edu.eg

Other Identifiers

Pilates on osteoporosis BCS26

Identifier Type: -

Identifier Source: org_study_id