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Effects of a Pilates Studio Program on Quality of Life and Functional Capacity of Women Undergoing Breast Cancer Treatment (Cancer)

13 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Andréa D Reis Dra., Teacher
  • Numer telefonu: 98987220570
  • E-mail: andrea.dr@ufma.br

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Pilates Studio Program Group

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.

Inne nazwy:
  • Pilates studio intervention in breast cancer treatment
  • Effects of Pilates studio in the treatment of breast cancer.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain assessment
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
Fatigue
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
General quality of life evaluation
Ramy czasowe: 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.
From enrollment to end of treatment in 16 weeks
Quality of life specifically for breast cancer
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
Sarcopenia
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
Functional capacity of upper limbs
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
Functional capacity of the upper limbs
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks
Quality of life specifically for breast cancer
Ramy czasowe: 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.
From registration to the end of treatment in 16 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Functional Capacity: 6-minute walk test
Ramy czasowe: From registration to the end of treatment in 16 weeks
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.
From registration to the end of treatment in 16 weeks
Functional capacity: 6-minute step test
Ramy czasowe: From registration to the end of treatment in 16 weeks
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.
From registration to the end of treatment in 16 weeks
Functional independence
Ramy czasowe: From registration to the end of treatment in 16 weeks
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.
From registration to the end of treatment in 16 weeks
General Flexibility
Ramy czasowe: From registration to the end of treatment, in 16 weeks
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.
From registration to the end of treatment, in 16 weeks
Upper limb strength
Ramy czasowe: From registration to the end of treatment, in 16 weeks
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.
From registration to the end of treatment, in 16 weeks
Lower limb strength
Ramy czasowe: From registration to the end of treatment, in 16 weeks
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.
From registration to the end of treatment, in 16 weeks
Muscle Mass
Ramy czasowe: From registration to the end of treatment, in 16 weeks.
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.
From registration to the end of treatment, in 16 weeks.
Self-esteem
Ramy czasowe: From registration to the end of treatment in 16 weeks
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.
From registration to the end of treatment in 16 weeks
Anxiety and Depression
Ramy czasowe: From registration to the end of treatment, in 16 weeks.
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.
From registration to the end of treatment, in 16 weeks.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Federal University of Maranhao

Śledczy

  • Główny śledczy: Andrea Dias Reis, Teacher, Federal University of Maranhão, São Luís, Maranhão, Brazil

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2026

Zakończenie podstawowe (Szacowany)

15 września 2026

Ukończenie studiów (Szacowany)

16 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

8 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CAAE: 88530425.5.0000.5087

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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