Breasts - FemaleCancerNCT07599098
Effects of a Pilates Studio Program on Quality of Life and Functional Capacity of Women Undergoing Breast Cancer Treatment
A study testing Pilates Studio Program Group in people with Breasts - Female and Breast Cancer, run by Federal University of Maranhao.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breasts - Female, Breast Cancer, Breast Cancer in Women
- What is being tested?
- Pilates Studio Program Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 16 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hyrllanny P Santos Hyrllanny Pereira dos Santos, Student contact
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Breasts - Female, Breast Cancer, Breast Cancer in Women
- Being tested
- Pilates Studio Program Group
- Keywords
- Neoplasia, Pilates, Quality of life, Functional capacity
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Studio Program GroupBehavioural
Also called Pilates studio intervention in breast cancer treatment, Effects of Pilates studio in the treatment of breast cancer.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Studio Programming Group | Experimental | 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. Receives: Behavioral: Pilates Studio Program Group |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
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.
Measured: From registration to the end of treatment in 16 weeks
Fatigue
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.
Measured: From registration to the end of treatment in 16 weeks
General quality of life evaluation
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.
Measured: From enrollment to end of treatment in 16 weeks
Quality of life specifically for breast cancer
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.
Measured: From registration to the end of treatment in 16 weeks
Sarcopenia
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.
Measured: From registration to the end of treatment in 16 weeks
Functional capacity of upper limbs
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.
Measured: From registration to the end of treatment in 16 weeks
Functional capacity of the upper limbs
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.
Measured: From registration to the end of treatment in 16 weeks
Quality of life specifically for breast cancer
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.
Measured: From registration to the end of treatment in 16 weeks
Secondary outcomes (9)
Functional Capacity: 6-minute walk test
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.
Measured: From registration to the end of treatment in 16 weeks
Functional capacity: 6-minute step test
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.
Measured: From registration to the end of treatment in 16 weeks
Functional independence
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.
Measured: From registration to the end of treatment in 16 weeks
General Flexibility
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.
Measured: From registration to the end of treatment, in 16 weeks
Upper limb strength
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.
Measured: From registration to the end of treatment, in 16 weeks
Lower limb strength
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.
Measured: From registration to the end of treatment, in 16 weeks
Muscle Mass
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.
Measured: From registration to the end of treatment, in 16 weeks.
Self-esteem
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.
Measured: From registration to the end of treatment in 16 weeks
Anxiety and Depression
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.
Measured: From registration to the end of treatment, in 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breasts - 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Maranhao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Dias Reis, Federal University of Maranhao
- Investigators
- Andrea Dias Reis, Teacher, Principal investigator, Federal University of Maranhão, São Luís, Maranhão, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599098
- Sponsor's protocol ID
- CAAE: 88530425.5.0000.5087
- Acronym
- Cancer
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07599098
- Acronym / sponsor ID
- Cancer / CAAE: 88530425.5.0000.5087
- Conditions
- Breasts - Female, Breast Cancer, Breast Cancer in Women
- Keywords
- Neoplasia, Pilates, Quality of life, Functional capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 16 Nov 2026 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Studio Programming Group | Experimental | Behavioral: Pilates Studio Program GroupThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates Studio Program GroupAlso: Pilates studio intervention in breast cancer treatment, Effects of Pilates studio in the treatment of breast cancer.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. | Behavioural | Pilates Studio Programming Group |
Primary outcome
Pain assessment
Time frame: From registration to the end of treatment in 16 weeks
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.
Fatigue
Time frame: From registration to the end of treatment in 16 weeks
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.
General quality of life evaluation
Time frame: From enrollment to end of treatment in 16 weeks
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.
Quality of life specifically for breast cancer
Time frame: From registration to the end of treatment in 16 weeks
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.
Sarcopenia
Time frame: From registration to the end of treatment in 16 weeks
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.
Functional capacity of upper limbs
Time frame: From registration to the end of treatment in 16 weeks
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.
Functional capacity of the upper limbs
Time frame: From registration to the end of treatment in 16 weeks
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.
Quality of life specifically for breast cancer
Time frame: From registration to the end of treatment in 16 weeks
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.
9 secondary outcomes
Functional Capacity: 6-minute walk test
Time frame: From registration to the end of treatment in 16 weeks
Functional capacity: 6-minute step test
Time frame: From registration to the end of treatment in 16 weeks
Functional independence
Time frame: From registration to the end of treatment in 16 weeks
General Flexibility
Time frame: From registration to the end of treatment, in 16 weeks
Upper limb strength
Time frame: From registration to the end of treatment, in 16 weeks
Lower limb strength
Time frame: From registration to the end of treatment, in 16 weeks
Muscle Mass
Time frame: From registration to the end of treatment, in 16 weeks.
Self-esteem
Time frame: From registration to the end of treatment in 16 weeks
Anxiety and Depression
Time frame: From registration to the end of treatment, in 16 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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.
Hyrllanny P Santos Hyrllanny Pereira dos Santos, Student contact
Andrea Dias Reis, Teacher principal investigator
Federal University of Maranhão, São Luís, Maranhão, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Studio Program Group in people with Breasts - Female and Breast Cancer, run by Federal University of Maranhao.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andréa D Reis Dra., Teacher (98987220570, andrea.dr@ufma.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: From registration to the end of treatment in 16 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.