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

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

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Pain assessment [Time frame: From registration to the end of treatment in 16 weeks]
• Fatigue [Time frame: From registration to the end of treatment in 16 weeks]
• General quality of life evaluation [Time frame: From enrollment to end of treatment in 16 weeks]
• Quality of life specifically for breast cancer [Time frame: From registration to the end of treatment in 16 weeks]
• Sarcopenia [Time frame: From registration to the end of treatment in 16 weeks]
• Functional capacity of upper limbs [Time frame: From registration to the end of treatment in 16 weeks]
• Functional capacity of the upper limbs [Time frame: From registration to the end of treatment in 16 weeks]
• Quality of life specifically for breast cancer [Time frame: From registration to the end of treatment in 16 weeks]

Secondary outcome measures (9)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07599098 · CAAE: 88530425.5.0000.5087

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗