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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pilates Exercises

    Other intervention

    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

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Base line and after 12 weeks

Secondary outcomes

1

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

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)

Time frame
Base line and after 12 weeks

Other outcomes

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