Influence of Pilates Method Intervention on Changes in Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Quality of life - Global Health Status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •invasive breast cancer stage IV according to TNM classification
- •performance status according to ECOG classification 2-4
- •unregulated hypertension
- •unstable ischemic heart disease
- •rheumatic diseases
- •osteoporosis
- •advanced osteoarthritis
- •disease of rheumatic origin (AS, RA, fibromyalgia)
- •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%).
结局指标
主要结局
Quality of life - Global Health Status
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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 Interference Total Score, Physical Interference, Affective Interference
时间窗: 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
时间窗: 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.
Subjective pain assessment - Pain Severity Total Score
时间窗: 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).
Myofascial stiffness
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
relative Power Output
时间窗: 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).
absolute Power Output
时间窗: 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).
Ventilatory equivalent for carbon dioxide
时间窗: 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).
Power Output when respiratory ratio (RQ) equal 1
时间窗: 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).
Minute ventilation per carbon dioxide production VE/VCO2 slope
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Body Height(before and after 12-week intervention)
- Body Mass(before and after 12-week intervention)
- Total Body Mass(before and after 12-week intervention, test conducted while fasting)
- Bone Mass(before and after 12-week intervention, test conducted while fasting)
- Muscle Mass(before and after 12-week intervention, test conducted while fasting)
- Skeletal Muscle Mass(before and after 12-week intervention, test conducted while fasting)
- Fat Mass(before and after 12-week intervention, test conducted while fasting)
- Visceral Adipose Tissue 2(before and after 12-week intervention, test conducted while fasting)
- Relative Skeletal Muscle Mass Index(before and after 12-week intervention, test conducted while fasting)
- Intra-Cellular Water(before and after 12-week intervention, test conducted while fasting)
- Total Body Water(before and after 12-week intervention, test conducted while fasting)
- Bone Mineral Density(before and after 12-week intervention, test conducted while fasting)
- Lean Body Mass(before and after 12-week intervention, test conducted while fasting)
- Fat-Free Mass(before and after 12-week intervention, test conducted while fasting)
- Visceral Adipose Tissue 1(before and after 12-week intervention, test conducted while fasting)
- Body Mass Index(before and after 12-week intervention, test conducted while fasting)
- Extra-Cellular Water(before and after 12-week intervention, test conducted while fasting)
- Bone Mass Component(before and after 12-week intervention, test conducted while fasting)
- T-Score(before and after 12-week intervention, test conducted while fasting)
- Z-Score(before and after 12-week intervention, test conducted while fasting)
- Inflammatory hematological ratios(before and after 12-week intervention)
- Level of Physical activity(before and after 12-week intervention)
- Oxygen Pulse(before and after 12-week intervention)
- Breathing Frequency(before and after 12-week intervention)
- Respiratory Exchange Ratio(before and after 12-week intervention)
- Ventilatory Efficiency(before and after 12-week intervention)
- Tidal Volume(before and after 12-week intervention)
- Speed(before and after 12-week intervention)
- Distance(before and after 12-week intervention)
- Indicators of vascular circulation(baseline (before and immediately after CPET) and after 12-week intervention (before and immediately after CPET))