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

NCT07599098 | Not Yet Recruiting

• 1 other identifier: CAAE: 88530425.5.0000.5087
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Breasts - Female; Breast Cancer; Breast Cancer in Women

Keywords

Neoplasia; Pilates; Quality of life; Functional capacity

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From registration to the end of treatment in 16 weeks

Secondary Outcomes (9)

• Functional Capacity: 6-minute walk test

  From registration to the end of treatment in 16 weeks

• Functional capacity: 6-minute step test

  From registration to the end of treatment in 16 weeks

• Functional independence

  From registration to the end of treatment in 16 weeks

• General Flexibility

  From registration to the end of treatment, in 16 weeks

• Upper limb strength

  From registration to the end of treatment, in 16 weeks

Study Arms (2)

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.

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.

Interventions

Pilates Studio Program Group BEHAVIORAL

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.

Also known as: Pilates studio intervention in breast cancer treatment, Effects of Pilates studio in the treatment of breast cancer.

Pilates Studio Programming Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Maranhao: lead

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Dias Reis, Teacher

  Federal University of Maranhão, São Luís, Maranhão, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andréa D Reis Dra., Teacher

CONTACT

98987220570; andrea.dr@ufma.br

Hyrllanny P Santos Hyrllanny Pereira dos Santos, Student

CONTACT

98988359435; hyrllanny.santos@discente.ufma.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Graduate Program in Physical Education at the Federal University of Maranhão, São Luís - MA, Brazil.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 20, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 16, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05