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

NCT07334626 | Recruiting

• 1 other identifier: Pilates on osteoporosis BCS26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pilates exercises; breast cancer survivors; bone mineral denisty; aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD) measurement

  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 Outcomes (1)

• Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire.

  Base line and after 12 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Other: Pilates Exercises; Drug: Calcium and Vitamin D Supplementation

Control group

ACTIVE COMPARATOR

Drug: Calcium and Vitamin D Supplementation

Interventions

Pilates Exercises 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.

Study group

Calcium and Vitamin D Supplementation 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; Study group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, 11603, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis; Bone Diseases, Metabolic

Interventions

Exercise Movement Techniques; Calcium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Central Study Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

CONTACT

01096968910; mahmoud.mohamed@fpt.bu.edu.eg

Ahmed Mounir Salama Associate Professor, Ph.D

CONTACT

ahmed.moumir@fpt.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) This is a parallel group randomized controlled trial with two arms receiving different interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

EG (1)