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Completed

NCT Number: NCT07334626

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

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.

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Key information

Conditions

Breast Cancer Aromatase Inhibitors Bone Diseases Bone Diseases, Metabolic Breast Cancer Survivors Breast Diseases Breast Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Osteoporosis or Osteopenia Pilates Exercise Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, 11603, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Bone mineral density (BMD) measurement

    Time frame: Base line and after 12 weeks

    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.

Secondary outcomes

  1. 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 were calculated according to standardized scoring guidelines, with higher scores indicating better quality of life. Participants completed the questionnaire at baseline (pre-intervention) and at 12 weeks (post-intervention)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Acronym: PilatesBCS2026

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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