Effects of a Pilates Studio Program on Quality of Life and Functional Capacity of Women Undergoing Breast Cancer Treatment (Cancer)
2026年5月13日 更新者：Andréa Dias Reis、Federal University of Maranhao
Effects of a Pilates Studio Program on Quality of Life, Functional Capacity, Pain, Fatigue, Sarcopenia, Flexibility, Strength, Body Composition, Self-Esteem, Anxiety and Depression in Women Undergoing Breast Cancer Treatment
Introduction: Cancer treatment generates undesirable effects, directly affecting the functional and psychosocial capacity faced by breast cancer patients during treatment.
In order to evaluate the practical effects of a pilates studio program that aims to promote significant improvements in their quality of life, emotional and social well-being.
Objective: To assess quality of life, pain, fatigue, sarcopenia, flexibility of upper limbs, functional capacity, functional independence, general flexibility, strength of upper limbs and lower limbs, muscle mass, self-steem, anxiety and depression in women undergoing breast cancer treatment.
Method: This is a cross-sectional study in which the sample will be composed of female individuals undergoing cancer treatment who participated in a Pilates studio program, twice a week lasting 60 minutes with light to moderate exercises, the intervention will last 16 weeks.
The primary outcomes of study will be quality of life, pain, fatigue, sarcopenia, flexibility of upper limbs, functional capacity, functional independence.
The secondary outcomes of study will be general flexibility, strength of upper limbs and lower limbs, muscle mass, self-steem, anxiety and depression in women undergoing breast cancer treatment.
All evaluated using instruments: EORTC-QLQ-30 and EORTC-QLQ-23 questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire); Brief Pain Inventory; PIPER Fatigue Scale; SARC -F and SARC-Calf questionnaires; Back Scratch Test; Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH; Six-minute walk test (6MWT) and 6-Minute Step Test; Barthel Index; Schober test; Handgrip Strength and 30-second sit-to-stand test; Bioimpedance; Rosenberg Self-Esteem Scale and Hospital Anxiety and Depression Scale (HADS), respectively.
The data will be presented by descriptive statistics, for two independent samples and multivariate analysis, comparing the effects of the intervention between the two groups in the R 4.3.3
software.
Expected results: Improvement in primary and secondary outcomes due to adjustments in physical training, Pilates studio.
研究概览
详细说明
Breast cancer is one of the most common neoplasms and a leading cause of death among women worldwide, representing a significant public health problem.
Beyond the physiological impact of the disease, cancer treatment, which may include surgery, chemotherapy, radiotherapy, immunotherapy, and hormone therapy, is associated with various adverse physical and emotional effects.
Among the main impairments observed are pain, fatigue, loss of muscle strength, reduced flexibility, functional limitations of the upper limbs, changes in body composition, anxiety, depression, and significant impairments in quality of life.
These effects can directly compromise the functional autonomy, self-esteem, and overall well-being of patients during and after treatment.
In this context, physical exercise has been widely recommended as a complementary non-pharmacological strategy to minimize the side effects of breast cancer treatment.
Among the exercise modalities, the Pilates Studio method stands out for integrating muscle strengthening, respiratory control, flexibility, balance, and body awareness, promoting physical and psychosocial benefits.
Furthermore, Pilates allows for individualized adaptation of exercises, enabling women undergoing cancer treatment to perform activities safely and progressively according to their functional limitations.
Studies demonstrate that interventions based on the Pilates method can contribute to improved quality of life, functionality, muscle strength, range of motion, and reduced fatigue in women with breast cancer.
However, most research focuses on mat Pilates, with a scarcity of studies specifically addressing the effects of Studio Pilates, performed with specific equipment and progressive load control.
Therefore, this study aims to evaluate the effects of a Studio Pilates program on quality of life, functional capacity, pain, fatigue, sarcopenia, muscle strength, flexibility, body composition, self-esteem, anxiety, and depression in women undergoing breast cancer treatment.
It is expected that the results will contribute to expanding the scientific evidence on the use of Studio Pilates as a complementary therapeutic tool in cancer care, promoting the physical, functional, and emotional rehabilitation of this population.
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Andréa D Reis Dra., Teacher
- 电话号码：98987220570
- 邮箱：andrea.dr@ufma.br
研究联系人备份
- 姓名：Hyrllanny P Santos Hyrllanny Pereira dos Santos, Student
- 电话号码：98988359435
- 邮箱：hyrllanny.santos@discente.ufma.br
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Women aged 18 or older;
- Being under treatment for breast cancer (chemotherapy, radiotherapy, immunotherapy and/or hormone therapy);
- No previous neurological/musculoskeletal disorders that impede active movement;
- No recent surgeries.
Exclusion Criteria:
- Patients with problems secondary to breast cancer that limit active movement;
- Presence of inflammation or edema in the abdomen, groin, and upper and lower extremities;
- Having another type of cancer;
- Having a cognitive impairment or injury that prevents them from performing physical assessments or completing questionnaires.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Pilates Studio Programming Group
The intervention will consist of 16 weeks of in-person Pilates studio classes, three times a week in the mornings, lasting 60 minutes each, totaling 48 sessions.
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There will be 16 weeks of intervention, with in-person Pilates studio classes three times a week, lasting 60 minutes each, in the morning, totaling 48 sessions. The classes will follow this order: Warm-up with initial stretches, lasting 10 minutes. This will be followed by the Pilates program lasting 40 minutes, and concluding with a 10-minute relaxation period. Every four weeks there will be a progression in intensity, with modifications to the exercises.
其他名称：
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无干预：Control group
Participants in the Control Group will receive standard care.
They will not participate in the intervention, only answering questionnaires and performing tests during the initial assessment periods, after 4 weeks, 8 weeks, 12 weeks, and after 16 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain assessment
大体时间：From registration to the end of treatment in 16 weeks
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Pain will be assessed using the Brief Pain Inventory (BPI), a 10-point pain intensity scale ranging from 0 (no pain) to 10 (worst imaginable pain), developed specifically for patients with cancer-related pain.
In addition, the BPI provides information on how pain interferes with daily functioning in 7 areas: general activity, walking, mood, sleep, work, enjoyment of life, and social activity.
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From registration to the end of treatment in 16 weeks
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Fatigue
大体时间：From registration to the end of treatment in 16 weeks
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Fatigue will be measured using the Piper Fatigue Scale (PFS-P).
Fatigue is a relevant symptom for cancer patients, with a greater impact than in the general population.
It is described at all stages of the cancer patient's journey, presenting as physical, emotional, or cognitive exhaustion or weakness, which can interfere with daily function and chemotherapy treatment.
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From registration to the end of treatment in 16 weeks
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General quality of life evaluation
大体时间：From enrollment to end of treatment in 16 weeks
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The instrument used to assess Quality of life will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
The questions are using a numerical scale from 0 to 100 for scales.
In the functional and global scales the EORTC-BR 30, the higher scores mean a better quality of life and lower scores mean a worse quality of life.
Unlike, in the symptom scale EORTC-BR 30, the higher scores mean a worse quality of life and lower scores mean a better quality of life.
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From enrollment to end of treatment in 16 weeks
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Quality of life specifically for breast cancer
大体时间：From registration to the end of treatment in 16 weeks
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The instrument used to assess Quality of life specifically for breast cancer will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-BR).
The questions are using a numerical scale from 0 to 100 for scales.
In the functional scale the EORTC-BR 23, the higher scores mean a better quality of life and lower scores mean a worse quality of life.
Unlike, in the symptom scale the EORTC-BR 23, the higher scores mean a worse quality of life and lower scores mean a better quality of life.
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From registration to the end of treatment in 16 weeks
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Sarcopenia
大体时间：From registration to the end of treatment in 16 weeks
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Sarcopenia assessment will be performed using the SARC-F questionnaire.
The protocol includes five components: strength, assisted gait, rising from a chair, climbing stairs, and falls.
The SARC-F items were selected to reflect changes in health status associated with the consequences of sarcopenia.
SARC-F scale scores range from 0 to 10 (i.e., 0-2 points for each component; 0 = best to 10 = worst) and were dichotomized to represent symptomatic (4+) versus healthy (0-3) status.
Additionally, a modified version of the instrument, the SARC-Calf (SARC-F + CP), which integrates an anthropometric measure into the traditional score, was employed.
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From registration to the end of treatment in 16 weeks
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Functional capacity of upper limbs
大体时间：From registration to the end of treatment in 16 weeks
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The Back Scratch Test is part of the battery of physical fitness tests for older adults and is used to measure the flexibility and range of motion of the shoulder joint (scapular girdle).
The test consists of placing one hand on the same shoulder and the other hand underneath, attempting to touch or overlap the middle fingers of both hands on the back.
The distance between the fingers is measured, where positive values indicate overlap and negative values indicate the distance remaining for touch.
Test scores are classified as: negative (-): If the fingers do not touch (distance between them); zero (0): If the fingers only touch; positive (+): If the fingers overlap.
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From registration to the end of treatment in 16 weeks
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Functional capacity of the upper limbs
大体时间：From registration to the end of treatment in 16 weeks
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The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated self-administered instrument for assessing symptoms and functional capacity in individuals with musculoskeletal disorders of the upper limbs. The questionnaire is validated for Brazilian Portuguese and consists of 30 items that assess an individual's ability to perform certain physical activities (21 items), the severity of symptoms such as pain, tingling, and weakness (5 items), and the impact of upper limb function on social life, work, sleep, and self-confidence (4 items). Each item is scored on a scale of 1 to 5. DASH score = ({Sum of responses}/{n} - 1 ) x 25. Where n is the number of questions answered. The score ranges from 0 to 100, where the higher the value, the greater the functional disability. |
From registration to the end of treatment in 16 weeks
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Quality of life specifically for breast cancer
大体时间：From registration to the end of treatment in 16 weeks
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The instrument used to assess quality of life specifically in cases of breast cancer will be the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-BR).
The questions use a numerical scale from 0 to 100.
On the functional scale of the EORTC-BR-23, higher scores indicate better quality of life and lower scores indicate worse quality of life.
On the symptom scale of the EORTC-BR-23, higher scores indicate worse quality of life and lower scores indicate better quality of life.
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From registration to the end of treatment in 16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Capacity: 6-minute walk test
大体时间：From registration to the end of treatment in 16 weeks
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Functional capacity, or cardiorespiratory fitness, will be assessed using the 6-minute walk test performed in a 10-meter corridor.
The patient will be monitored during the test for safety.
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From registration to the end of treatment in 16 weeks
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Functional capacity: 6-minute step test
大体时间：From registration to the end of treatment in 16 weeks
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Functional capacity will be assessed using the 6-minute step test.
The test consists of repeatedly stepping up and down a step with a standardized height between 20 and 30 cm for a continuous period of six minutes, with the total number of cycles or steps completed being recorded at the end of the established time.
The patient will be monitored during the test for safety.
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From registration to the end of treatment in 16 weeks
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Functional independence
大体时间：From registration to the end of treatment in 16 weeks
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The Barthel Index is a widely used instrument to assess the degree of functional independence of individuals in performing basic activities of daily living.
Its score ranges from 0 to 100 points, distributed across ten dimensions that encompass tasks related to self-care and mobility.
It is a validated measure for Portuguese, with evidence of reliability and clinical applicability in different contexts of functional assessment.
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From registration to the end of treatment in 16 weeks
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General Flexibility
大体时间：From registration to the end of treatment, in 16 weeks
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For flexibility assessment, the Schober test was used, which determines functional flexibility and is more specific to the lumbar region.
It is a test with high specificity compared to the gold standard, radiography.
However, it is a quick and low-cost test, widely used in clinical practice.
The test evaluates lumbar movement restrictions through markings: on the lumbosacral joint (joining the posterior superior iliac spines) and 10 cm above; the distance between these markings is noted in an upright position.
Immediately after, the subject performs a maximum trunk flexion (lower limbs extended), and the evaluator measures the new distance between the points with a measuring tape and records the difference between the marks based on the patient's best reach score in relation to the ground.
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From registration to the end of treatment, in 16 weeks
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Upper limb strength
大体时间：From registration to the end of treatment, in 16 weeks
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Measuring handgrip strength using a dynamometer is a simple, objective, practical, and easy-to-use procedure.
Recommended by the American Society of Hand Therapists.
The instruction is to perform a maximum contraction for 3 seconds in each test.
A 30-second rest period is required between each test, and a 2-minute rest period is required between tests for each hand.
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From registration to the end of treatment, in 16 weeks
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Lower limb strength
大体时间：From registration to the end of treatment, in 16 weeks
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The 30-Second Chair Stand Test is widely used to assess lower limb strength and muscle endurance in clinical and elderly populations.
The protocol requires the participant to stand from a chair and sit down as many times as possible within 30 seconds, without using their hands.
Performance on this test is a strong predictor of functional autonomy and is directly related to screening for sarcopenia risk.
Classification varies according to age and conditioning achieved during the test, defined as: Disability Risk: >8 repetitions for women are considered predictors of high risk of falls and loss of autonomy; Cutoff Point for Sarcopenia: >15 repetitions is an indicator of reduced muscle quality.
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From registration to the end of treatment, in 16 weeks
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Muscle Mass
大体时间：From registration to the end of treatment, in 16 weeks.
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It will be measured using Bioelectrical Impedance Analysis (BIA), a widely used method that estimates muscle mass by measuring the body's resistance and reactance to the passage of a low-intensity electrical current, and is low-cost, easy to apply, and portable.
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From registration to the end of treatment, in 16 weeks.
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Self-esteem
大体时间：From registration to the end of treatment in 16 weeks
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To assess self-esteem, the Portuguese version adapted and validated by Hutz of the Rosenberg Self-Esteem Scale will be used.
The total score ranges from 10 to 40 points.
Higher scores indicate better self-esteem and lower scores indicate worse self-esteem.
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From registration to the end of treatment in 16 weeks
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Anxiety and Depression
大体时间：From registration to the end of treatment, in 16 weeks.
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Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
The total score ranges from 0 to 21 points.
The cut-off points adopted will be: an anxiety score of 8 or higher; and a depression score of 9 or higher.
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From registration to the end of treatment, in 16 weeks.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrea Dias Reis, Teacher、Federal University of Maranhão, São Luís, Maranhão, Brazil
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月15日
初级完成 (估计的)
2026年9月15日
研究完成 (估计的)
2026年11月16日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.