Breast CancerPilatesBCS2026NCT07334626
Impact of Pilates Exercises on Bone Mineral Density in Breast Cancer Survivors Receiving Hormonal Therapy
A study testing Pilates Exercises and Calcium and Vitamin D Supplementation in people with Breast Cancer and Breast Cancer Survivors, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Survivors, Aromatase Inhibitors
- What is being tested?
- Pilates Exercises and Calcium and Vitamin D Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, faculty of Physical Therapy, Benha university
Banhā, Benha, 11603
About this study
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.
Read the 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
- Being tested
- Pilates Exercises, Calcium and Vitamin D Supplementation
- Keywords
- pilates exercises, breast cancer survivors, bone mineral denisty, aromatase inhibitors
- Medical subject headings
- Breast Neoplasms, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
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 SupplementationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Pilates Exercises; Drug: Calcium and Vitamin D Supplementation |
| Control group | Active comparator | Not described Receives: Drug: Calcium and Vitamin D Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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)
Measured: Base line and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2026
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamada Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334626
- Sponsor's protocol ID
- Pilates on osteoporosis BCS26
- Acronym
- PilatesBCS2026
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pilates Exercises on Bone Mineral Density in Breast Cancer Survivors Receiving Hormonal Therapy
- ClinicalTrials.gov ID
- NCT07334626
- Acronym / sponsor ID
- PilatesBCS2026 / Pilates on osteoporosis BCS26
- Conditions
- Breast Cancer, Breast Cancer Survivors, Aromatase Inhibitors, Osteoporosis or Osteopenia, Pilates Exercise
- Keywords
- pilates exercises, breast cancer survivors, bone mineral denisty, aromatase inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Pilates Exercises, Drug: Calcium and Vitamin D Supplementation |
| Control group | Active comparator | Drug: Calcium and Vitamin D Supplementation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisesPilates 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 | Other | Study group |
| Calcium and Vitamin D SupplementationParticipants 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. | Drug | Control group, Study group |
Primary outcome
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.
1 secondary outcome
Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire.
Time frame: Base line and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises and Calcium and Vitamin D Supplementation in people with Breast Cancer and Breast Cancer Survivors, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (BMD) measurement (time frame: Base line and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.