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

NCT07334626 | Completed

• 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

  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 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

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

Study group

Calcium and Vitamin D Supplementation DRUG

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.

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

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physiotherapists and participants were not blind to group allocation, given the study nature (exercise). However, the physiotherapist who administered the HRQoL assessment remained blinded throughout the study, and participants were instructed not to disclose their treatment during assessment. BMD measurements were performed and interpreted independently by a certified radiologist blinded to treatment group, according to the standard DEXA protocol. Statistical analyses were conducted using coded datasets, with treatment allocation concealed throughout all analyses.
• 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: July 20, 2026
• Study Completion: July 20, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-01

Locations

EG (1)