Breast Cancer FemaleNCT06419023
Impact of Pilates Method on Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Breast Cancer Women
A study testing supervised physical activity intervention using the Pilates Method (exercises on the mat) in people with Breast Cancer Female, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The effectiveness of breast cancer treatment is quite well documented. Still, side effects can underpin other treatment-induced diseases such as osteopenia, diabetes, and especially cardiovascular dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- supervised physical activity intervention using the Pilates Method (exercises on the mat)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2022to 15 Dec 2023
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with invasive breast cancer
- stage of disease according to TNM classification I-III
- cancer with estrogen receptor expression in at least 10% of cell nuclei
- supplemental hormone therapy with an aromatase inhibitor used for at least 6 months
- performance status according to ECOG classification 0-1
- BMI of 18.5-30
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- without chronic diseases affecting the limitation of the use of oncological treatment
- without contraindications to participation in group supervised Pilates classes
- participation in at least 17 of 24 classes according to the proposed schedule
Who cannot join
- invasive breast cancer stage IV according to TNM classification
- performance status according to ECOG classification 2-4
- unregulated hypertension
- unstable ischemic heart disease
- arrhythmia
- rheumatic diseases
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- osteoporosis
- advanced osteoarthritis
- disease of rheumatic origin (AS, RA, fibromyalgia)
- pregnancy
- BMI < 18.5 or above 30
- unregulated hypothyroidism/hyperthyroidism
- Criteria for drop out The criteria for discontinuing allocated interventions are as follows: 1) participant's voluntary withdrawal from the study; 2) worsening of oncological prognosis that prevents the continuation; 3) absence of training sessions due to unjustified reasons in the case of the PG (compliance below 70%).
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Greater Poland Voivodeship, 60-871
About this study
Official title: Influence of Pilates Method Intervention on Changes in Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Women With Breast Cancer
The effectiveness of breast cancer treatment is quite well documented. Still, side effects can underpin other treatment-induced diseases such as osteopenia, diabetes, and especially cardiovascular dysfunction. Therefore, finding a method that could partly counteract these side effects and at the same time be implemented throughout treatment is a challenge for researchers.
The main purpose of this experimental, randomized control trial was to analyze the effect of the Pilates Method (PM) intervention on changing the myofascial stiffness along the thoracic and lumbar spine, cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy. The apllied procedure of 12 -week PM training included the training intervention based on hypothesis:
Read more
- PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy
- PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy
- PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy.
Possible practical applications include the domains of exercise medicine, physical activity in cancer and public health.
Read the detailed description
The trial was conducted by Poznan University of Physical Education in cooperation with UMP (Poland).
This design of trial assumed the parallel two-arm group, prospective, randomized controlled trial (RCT) comparing an exercises-based intervention (experimental group) to usual care and physical activity recommendation (control group) in women with breast cancer with perioperative hormonal treatment AI.Randomization were performed as a simple randomization with a 1:1 allocation (coin toss).
All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study.
Before enrollment, all participants were given detailed information about experiment, procedures, risks, and benefits of the study and gave their written consent to participation. The patients were informed at any stage of the project may resign from participation without having to give a reason.The study was conducted in two stages. Patient recruitment and data collection started in February 2022. The baseline assessment of patients is carried out two weeks before the start of PT intervention. PT intervention lasted 12 weeks. Post-intervention assessment is performed during two weeks after PT intervention. Finally data (reports) collection and data preparation for analysis were completed in December 2023.
Potential patients matching primary criteria underwent clinical, laboratory, EKG and echocardiographic follow-up assessment by cardiologist. Clinical specialists eligible for the study provided information about the study and presented informed consent to patients. The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research.
Together with oncologists the research group also included sports physiologists, cardiologist, certified Pilates teacher. All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention. Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information.
At the baseline and post training period were performed following assessments:
- anthropometrics using digital stadiometer
- body composition tested by the dual X-ray absorptiometry method
- bone mineral density tested by the dual X-ray absorptiometry method
- questionnaire assessment of: (i) quality of life using EORTC QLQ-C30 Questionnaire version 3.0, EORTC QLQ-BR23 Questionnaire Breast cancer module), (ii) pain using Brief Pain Inventory Short Form Questionnaire), (iii) level of physical activity using IPAQ Questionnaire
- myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination
- respiratory function measured with spirometric tests
- cardiorespiratory fitness measured with: (i) cardiopulmonary exercise test CPET on the treadmil, (ii) metabolic response assessment with blood lactic acid concentration, (iii) subjective rating of perceived exertion with the Borg 6-20 scale
- vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence
- inflammatory hematological ratios were calculated based on hematological medical patients indicators.
Patients characteristics has been completed by medical records and socio-demographic questionnaires.
The supervised physical activity intervention using the Pilates Method (60min each session, 2 sessions each week over 12 weeks) was used in this study.
In the study took part two groups - Exercise Group (experimental group performing PM intervention) and Usual-Care Group (control group).
The training program involved exercise performed on mats. The subjects took part in a model training session, during which all exercises were explained, performance was discussed, common mistakes were pointed out, and efforts were made to maintain proper exercise intensity and muscle activation and relaxation.The model PM training sessions was consisted of:
- warm-up and respiratory exercises (5-10 min);
- mat Pilates exercises with the traditional Pilates repertoire (basic, beginner) adapted for breast cancer patients needs and restrictions (40 min);
- cool down and endings exercises (5 min);
- session summary (2-3min). The training program was supervised by the same specialist of PM.
- Conditions
- Breast Cancer Female
- Being tested
- supervised physical activity intervention using the Pilates Method (exercises on the mat)
- Keywords
- Pilates Method, quality of life, myofascial stiffness, pain, cardiorespiratory fitness, inflammation, breast cancer, aromatase inhibitor
- Medical subject headings
- Pain, Inflammation, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised physical activity intervention using the Pilates Method (exercises on the mat)Behavioural
Each Pilates session was consisted of: a) introduction to the goal of training, familiarizing new skills (2-3 min); b) Pre-Pilates warm-up and respiratory exercises (5-10 min); c) mat Pilates exercises with the traditional Pilates repertoire: basic, beginner (40 min); d) cool down and endings exercises (5 min); e) session summary (2-3min). When required, exercises were adapted for breast cancer body needs and restrictions. Depending on the purpose of the exercise, different equipment was used (Pilates small ball 22 cm, Swiss ball, small massage balls, resistance band, towels, rollers, boxes, "Magic Circle").
| Study group | Role | What they receive |
|---|---|---|
| Exercises group (EG) | Experimental | The exercise group (EG) participated in supervised physical activity intervention using the Pilates Method (exercises on the mat, 60min each session, 2 sessions each week over 12 weeks) were administered by certified Pilates teacher. Receives: Behavioral: supervised physical activity intervention using the Pilates Method (exercises on the mat) |
| Usual-Care Group (U-CG) | No intervention | Patients in the U-CG were instructed to continue with their usual activities: a) to avoid changing their diet habits during intervention; b) being physically active as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life - Global Health Status
Quality of life - Global Health Status (GHS) assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 7. A high score represents a high QoL (better outcome).
Measured: before and after 12-week intervention
Quality of life - Functional scores
Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0.
On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).
Measured: before and after 12-week intervention
Quality of life - Symptom scores
Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0.
On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology /problems (worse outcome).
Measured: before and after 12-week intervention
Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective)
Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).
Measured: before and after 12-week intervention
Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss)
Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome).
Measured: before and after 12-week intervention
Subjective pain assessment - Pain Severity Total Score
Pain Severity Total Score assessment with Brief Pain Inventory (short form) Questionnaire. Pain severity is measured by four items: worst pain, least pain, average pain in the last 24 h, and pain now. On the scale minimum value is 0 (no pain), maximum value is 10 (pain as as you can imagine).
Measured: before and after 12-week intervention
Subjective pain assessment - Pain Interference Total Score, Physical Interference, Affective Interference
Pain Interference Total Score, Physical Interference, Affective Interference assessment with Brief Pain Inventory (short form) Questionnaire. The seven interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely".
Measured: before and after 12-week intervention
Subjective pain assessment - the extent of pain complaints
The extent of pain complaints assessment with Brief Pain Inventory (short form) Questionnaire. Pointing out on the body diagram the places where the subject feels pain.
Measured: before and after 12-week intervention
Myofascial stiffness
Myofascial stiffness (N/m) assessment using myotonometer, MyotonPro® .
Measured: before and after 12-week intervention, before and after unit Pilates session
Myofascial stiffness
Assessment of myofascial stiffness (kPa) and (m/s) using a non-invasive shear-wave elastography examination AIXPLORER SuperSonic Imagine.
Measured: before and after 12-week intervention
Resting Vital Capacity
Level of Resting Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Measured: before and after 12-week intervention
Forced Vital Capacity
Level of Forced Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Measured: before and after 12-week intervention
Maximal Voluntary Ventilation
Maximal Voluntary Ventilation (l/min). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Measured: before and after 12-week intervention
Forced Expiratory Volume in the first second of expiration
Forced Expiratory Volume in the first second of expiration in %. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Measured: before and after 12-week intervention
Peak Expiratory Flow
Peak Expiratory Flow (l/s). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany
Measured: before and after 12-week intervention
The modified Tiffeneau-Pinelli index
The modified Tiffeneau-Pinelli index is Forced Expiratory Volume in 1 second/ Vital Capacity ratio (%). A ratio below 70% is typically indicative of obstructive lung disease. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Measured: before and after 12-week intervention
absolute Oxygen Uptake
Absolute Oxygen Uptake (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
relative Oxygen Uptake
Relative Oxygen Uptake (l/min/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Volume of carbon dioxide
Volume of carbon dioxide (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
absolute Power Output
Absolute Power Output (Watts) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
relative Power Output
Relative Power Output (W/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Power Output when respiratory ratio (RQ) equal 1
Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Ventilatory equivalent for carbon dioxide
Ventilatory equivalent for carbon dioxide (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Minute ventilation per carbon dioxide production VE/VCO2 slope
Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Heart Rate
Resting and maximal Heart Rate (beats/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while an walking test on the treadmill using a heart rate monitor.
Measured: before and after 12-week intervention
Blood Lactic Acid Concentration
Metabolic response assessment with blood lactic acid concentration (mmol/l) are tasted before and after a cardiopulmonary exercise test (CPET) (Biosen C-line, EKF Diagnostics)
Measured: before and after 12-week intervention
Subjective rating of perceived exertion
Borg 6-20 scale was applied to indicate the level of exertion by participant at maximal oxygen uptake /peak oxygen uptake workload during CPET. On the scale minimum value is 6 (no exertion at all), maximum value is 20 (maximal exertion).
Measured: before and after 12-week intervention
Secondary outcomes (30)
Body Height
Body Height (m) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany).
Measured: before and after 12-week intervention
Body Mass
Body Mass (kg) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany).
Measured: before and after 12-week intervention
Total Body Mass
Total Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Bone Mass
Bone Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Muscle Mass
Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Skeletal Muscle Mass
Skeletal Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Lean Body Mass
Lean Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Fat Mass
Fat Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Fat-Free Mass
Fat-Free Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Visceral Adipose Tissue 1
Visceral Adipose Tissue (cm^3). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Visceral Adipose Tissue 2
Visceral Adipose Tissue (g). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Body Mass Index
Body Mass Index (BMI) (kg/m^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Relative Skeletal Muscle Mass Index
Relative Skeletal Muscle Mass Index (RSMI) (kg/m^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Intra-Cellular Water
Intra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device.
Measured: before and after 12-week intervention, test conducted while fasting
Extra-Cellular Water
Extra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device.
Measured: before and after 12-week intervention, test conducted while fasting
Total Body Water
Total Body Water (kg). Body water component measured using TANITA MC-98OMA plus device.using TANITA MC-98OMA plus device.
Measured: before and after 12-week intervention, test conducted while fasting
Bone Mineral Density
Bone Mineral Density (g/cm^2). Indicators of bone mineral density are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Bone Mass Component
Bone Mass Component (kg). Indicator is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
T-Score
T-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Z-Score
Z-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).
Measured: before and after 12-week intervention, test conducted while fasting
Inflammatory hematological ratios
Indicators of inflammation (Neutrophil to Lymphocyte ratio, Monocyte to Lymphocyte ratio, Platelet to Lymphocyte ratio) are calculated made based on hematological medical records.
Measured: before and after 12-week intervention
Level of Physical activity
A self-report scale that measures physical activity. The IPAQ comprises 27 items that assess time spent engaging in various levels of physical activity and includes sitting time. Participants are asked to report their responses in terms of minutes, hours, or days. The units of measurement are METs min/week. The amount of physical activity is assessed based on intensity (moderate, intense, walking), and the amount of total physical activity is calculated by summing up the records across each dimension by intensity. A category of low physical activity is considered a result in the total physical activity below 600 METs min/week, moderate between 600 and 3000 METs min/week and high above 3000 METs min/week. Scores can be computed continuously or categorically.
Measured: before and after 12-week intervention
Oxygen Pulse
Oxygen Pulse (ml). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Breathing Frequency
Breathing Frequency (breaths/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Respiratory Exchange Ratio
Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Ventilatory Efficiency
Ventilatory Efficiency (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Tidal Volume
Tidal Volume (l) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Speed
Speed (km/h). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Distance
Distance (m) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Measured: before and after 12-week intervention
Indicators of vascular circulation
Vascular circulation indicators (Reactive Hyperemia Response, Hypoxia Sensitivity, Normoxia Oscillatory Index, the rate of Nicotinamide Adenine Dinucleotide fluorescence growth) are measured with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland).
Measured: baseline (before and immediately after CPET) and after 12-week intervention (before and immediately after CPET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Feb 2022
- Primary completion15 Jan 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Tarnas, Master, Principal investigator, Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419023
- Sponsor's protocol ID
- MTarnas_PhD
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tarnas M, Stemplewski R, Ciekot-Soltysiak M, Pospieszna B, Kufel-Grabowska J, Marszalek A, Zielinski J, Ziemann E. Pilates Method as a complementary activity reduces myofascial stiffness and pain in women with breast cancer undergoing aromatase inhibitor therapy: a randomized controlled trial. Sci Rep. 2026 Jun 25. doi: 10.1038/s41598-026-58461-7. Online ahead of print.
PubMed 42350535
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pilates Method Intervention on Changes in Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06419023
- Acronym / sponsor ID
- MTarnas_PhD
- Conditions
- Breast Cancer Female
- Keywords
- Pilates Method, quality of life, myofascial stiffness, pain, cardiorespiratory fitness, inflammation, breast cancer, aromatase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 17 May 2024 (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.
The effectiveness of breast cancer treatment is quite well documented. Still, side effects can underpin other treatment-induced diseases such as osteopenia, diabetes, and especially cardiovascular dysfunction. Therefore, finding a method that could partly counteract these side effects and at the same time be implemented throughout treatment is a challenge for researchers.
The main purpose of this experimental, randomized control trial was to analyze the effect of the Pilates Method (PM) intervention on changing the myofascial stiffness along the thoracic and lumbar spine, cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy. The apllied procedure of 12 -week PM training included the training intervention based on hypothesis:
- PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy
- PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy
- PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy.
Possible practical applications include the domains of exercise medicine, physical activity in cancer and public health.
Detailed description
The trial was conducted by Poznan University of Physical Education in cooperation with UMP (Poland).
This design of trial assumed the parallel two-arm group, prospective, randomized controlled trial (RCT) comparing an exercises-based intervention (experimental group) to usual care and physical activity recommendation (control group) in women with breast cancer with perioperative hormonal treatment AI.Randomization were performed as a simple randomization with a 1:1 allocation (coin toss).
All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study.
Before enrollment, all participants were given detailed information about experiment, procedures, risks, and benefits of the study and gave their written consent to participation. The patients were informed at any stage of the project may resign from participation without having to give a reason.The study was conducted in two stages. Patient recruitment and data collection started in February 2022. The baseline assessment of patients is carried out two weeks before the start of PT intervention. PT intervention lasted 12 weeks. Post-intervention assessment is performed during two weeks after PT intervention. Finally data (reports) collection and data preparation for analysis were completed in December 2023.
Potential patients matching primary criteria underwent clinical, laboratory, EKG and echocardiographic follow-up assessment by cardiologist. Clinical specialists eligible for the study provided information about the study and presented informed consent to patients. The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research.
Together with oncologists the research group also included sports physiologists, cardiologist, certified Pilates teacher. All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention. Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information.
At the baseline and post training period were performed following assessments:
- anthropometrics using digital stadiometer
- body composition tested by the dual X-ray absorptiometry method
- bone mineral density tested by the dual X-ray absorptiometry method
- questionnaire assessment of: (i) quality of life using EORTC QLQ-C30 Questionnaire version 3.0, EORTC QLQ-BR23 Questionnaire Breast cancer module), (ii) pain using Brief Pain Inventory Short Form Questionnaire), (iii) level of physical activity using IPAQ Questionnaire
- myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination
- respiratory function measured with spirometric tests
- cardiorespiratory fitness measured with: (i) cardiopulmonary exercise test CPET on the treadmil, (ii) metabolic response assessment with blood lactic acid concentration, (iii) subjective rating of perceived exertion with the Borg 6-20 scale
- vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence
- inflammatory hematological ratios were calculated based on hematological medical patients indicators.
Patients characteristics has been completed by medical records and socio-demographic questionnaires.
The supervised physical activity intervention using the Pilates Method (60min each session, 2 sessions each week over 12 weeks) was used in this study.
In the study took part two groups - Exercise Group (experimental group performing PM intervention) and Usual-Care Group (control group).
The training program involved exercise performed on mats. The subjects took part in a model training session, during which all exercises were explained, performance was discussed, common mistakes were pointed out, and efforts were made to maintain proper exercise intensity and muscle activation and relaxation.The model PM training sessions was consisted of:
- warm-up and respiratory exercises (5-10 min);
- mat Pilates exercises with the traditional Pilates repertoire (basic, beginner) adapted for breast cancer patients needs and restrictions (40 min);
- cool down and endings exercises (5 min);
- session summary (2-3min). The training program was supervised by the same specialist of PM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises group (EG) | Experimental | Behavioral: supervised physical activity intervention using the Pilates Method (exercises on the mat)The exercise group (EG) participated in supervised physical activity intervention using the Pilates Method (exercises on the mat, 60min each session, 2 sessions each week over 12 weeks) were administered by certified Pilates teacher. |
| Usual-Care Group (U-CG) | No intervention | –Patients in the U-CG were instructed to continue with their usual activities: a) to avoid changing their diet habits during intervention; b) being physically active as usual. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- women with invasive breast cancer
- stage of disease according to TNM classification I-III
- cancer with estrogen receptor expression in at least 10% of cell nuclei
- supplemental hormone therapy with an aromatase inhibitor used for at least 6 months
- performance status according to ECOG classification 0-1
Key exclusion criteria (13 listed)
- invasive breast cancer stage IV according to TNM classification
- performance status according to ECOG classification 2-4
- unregulated hypertension
- unstable ischemic heart disease
- arrhythmia
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 |
|---|---|---|
| supervised physical activity intervention using the Pilates Method (exercises on the mat)Each Pilates session was consisted of: a) introduction to the goal of training, familiarizing new skills (2-3 min); b) Pre-Pilates warm-up and respiratory exercises (5-10 min); c) mat Pilates exercises with the traditional Pilates repertoire: basic, beginner (40 min); d) cool down and endings exercises (5 min); e) session summary (2-3min). When required, exercises were adapted for breast cancer body needs and restrictions. Depending on the purpose of the exercise, different equipment was used (Pilates small ball 22 cm, Swiss ball, small massage balls, resistance band, towels, rollers, boxes, "Magic Circle"). | Behavioural | Exercises group (EG) |
Primary outcome
Quality of life - Global Health Status
Time frame: before and after 12-week intervention
Quality of life - Global Health Status (GHS) assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 7. A high score represents a high QoL (better outcome).
Quality of life - Functional scores
Time frame: before and after 12-week intervention
Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).
Quality of life - Symptom scores
Time frame: before and after 12-week intervention
Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology /problems (worse outcome).
Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective)
Time frame: before and after 12-week intervention
Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).
Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss)
Time frame: before and after 12-week intervention
Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome).
Subjective pain assessment - Pain Severity Total Score
Time frame: before and after 12-week intervention
Pain Severity Total Score assessment with Brief Pain Inventory (short form) Questionnaire. Pain severity is measured by four items: worst pain, least pain, average pain in the last 24 h, and pain now. On the scale minimum value is 0 (no pain), maximum value is 10 (pain as as you can imagine).
Subjective pain assessment - Pain Interference Total Score, Physical Interference, Affective Interference
Time frame: before and after 12-week intervention
Pain Interference Total Score, Physical Interference, Affective Interference assessment with Brief Pain Inventory (short form) Questionnaire. The seven interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely".
Subjective pain assessment - the extent of pain complaints
Time frame: before and after 12-week intervention
The extent of pain complaints assessment with Brief Pain Inventory (short form) Questionnaire. Pointing out on the body diagram the places where the subject feels pain.
Myofascial stiffness
Time frame: before and after 12-week intervention, before and after unit Pilates session
Myofascial stiffness (N/m) assessment using myotonometer, MyotonPro® .
Myofascial stiffness
Time frame: before and after 12-week intervention
Assessment of myofascial stiffness (kPa) and (m/s) using a non-invasive shear-wave elastography examination AIXPLORER SuperSonic Imagine.
Resting Vital Capacity
Time frame: before and after 12-week intervention
Level of Resting Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Forced Vital Capacity
Time frame: before and after 12-week intervention
Level of Forced Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Maximal Voluntary Ventilation
Time frame: before and after 12-week intervention
Maximal Voluntary Ventilation (l/min). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Forced Expiratory Volume in the first second of expiration
Time frame: before and after 12-week intervention
Forced Expiratory Volume in the first second of expiration in %. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
Peak Expiratory Flow
Time frame: before and after 12-week intervention
Peak Expiratory Flow (l/s). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany
The modified Tiffeneau-Pinelli index
Time frame: before and after 12-week intervention
The modified Tiffeneau-Pinelli index is Forced Expiratory Volume in 1 second/ Vital Capacity ratio (%). A ratio below 70% is typically indicative of obstructive lung disease. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.
absolute Oxygen Uptake
Time frame: before and after 12-week intervention
Absolute Oxygen Uptake (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
relative Oxygen Uptake
Time frame: before and after 12-week intervention
Relative Oxygen Uptake (l/min/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Volume of carbon dioxide
Time frame: before and after 12-week intervention
Volume of carbon dioxide (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
absolute Power Output
Time frame: before and after 12-week intervention
Absolute Power Output (Watts) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
relative Power Output
Time frame: before and after 12-week intervention
Relative Power Output (W/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Power Output when respiratory ratio (RQ) equal 1
Time frame: before and after 12-week intervention
Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Ventilatory equivalent for carbon dioxide
Time frame: before and after 12-week intervention
Ventilatory equivalent for carbon dioxide (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Minute ventilation per carbon dioxide production VE/VCO2 slope
Time frame: before and after 12-week intervention
Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).
Heart Rate
Time frame: before and after 12-week intervention
Resting and maximal Heart Rate (beats/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while an walking test on the treadmill using a heart rate monitor.
Blood Lactic Acid Concentration
Time frame: before and after 12-week intervention
Metabolic response assessment with blood lactic acid concentration (mmol/l) are tasted before and after a cardiopulmonary exercise test (CPET) (Biosen C-line, EKF Diagnostics)
Subjective rating of perceived exertion
Time frame: before and after 12-week intervention
Borg 6-20 scale was applied to indicate the level of exertion by participant at maximal oxygen uptake /peak oxygen uptake workload during CPET. On the scale minimum value is 6 (no exertion at all), maximum value is 20 (maximal exertion).
30 secondary outcomes
Body Height
Time frame: before and after 12-week intervention
Body Mass
Time frame: before and after 12-week intervention
Total Body Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Bone Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Muscle Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Skeletal Muscle Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Lean Body Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Fat Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Fat-Free Mass
Time frame: before and after 12-week intervention, test conducted while fasting
Visceral Adipose Tissue 1
Time frame: before and after 12-week intervention, test conducted while fasting
Visceral Adipose Tissue 2
Time frame: before and after 12-week intervention, test conducted while fasting
Body Mass Index
Time frame: before and after 12-week intervention, test conducted while fasting
Relative Skeletal Muscle Mass Index
Time frame: before and after 12-week intervention, test conducted while fasting
Intra-Cellular Water
Time frame: before and after 12-week intervention, test conducted while fasting
Extra-Cellular Water
Time frame: before and after 12-week intervention, test conducted while fasting
Total Body Water
Time frame: before and after 12-week intervention, test conducted while fasting
Bone Mineral Density
Time frame: before and after 12-week intervention, test conducted while fasting
Bone Mass Component
Time frame: before and after 12-week intervention, test conducted while fasting
T-Score
Time frame: before and after 12-week intervention, test conducted while fasting
Z-Score
Time frame: before and after 12-week intervention, test conducted while fasting
Inflammatory hematological ratios
Time frame: before and after 12-week intervention
Level of Physical activity
Time frame: before and after 12-week intervention
Oxygen Pulse
Time frame: before and after 12-week intervention
Breathing Frequency
Time frame: before and after 12-week intervention
Respiratory Exchange Ratio
Time frame: before and after 12-week intervention
Ventilatory Efficiency
Time frame: before and after 12-week intervention
Tidal Volume
Time frame: before and after 12-week intervention
Speed
Time frame: before and after 12-week intervention
Distance
Time frame: before and after 12-week intervention
Indicators of vascular circulation
Time frame: baseline (before and immediately after CPET) and after 12-week intervention (before and immediately after CPET)
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 22 May 2024.
- Derived from this study: PubMed 42350535Tarnas M, Stemplewski R, Ciekot-Soltysiak M, Pospieszna B, Kufel-Grabowska J, Marszalek A, Zielinski J, Ziemann E. Pilates Method as a complementary activity reduces myofascial stiffness and pain in women with breast cancer undergoing aromatase inhibitor therapy: a randomized controlled trial. Sci Rep. 2026 Jun 25. doi: 10.1038/s41598-026-58461-7. Online ahead of print.
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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.
Maria Tarnas, Master principal investigator
Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised physical activity intervention using the Pilates Method (exercises on the mat) in people with Breast Cancer Female, run by Poznan University of Physical Education at 1 site in Poland.
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 9 inclusion and 13 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 22 May 2024. 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 Poland. 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?
Quality of life - Global Health Status (time frame: before and after 12-week intervention). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06419023, which also lists 1 linked publication.
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 22 May 2024.