Clinical trial · Interventional
Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy
Randomized Trial With Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant therapies resulted in an estimated increase of 22 million cancer survivors worldwide (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown benefits in the increase of the functional capacity that generates a reduction of effort and decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema, radiodermatitis and depression, in the women with breast cancer and with an indication of adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA). After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). Patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). Patients assigned to the control group will not participate in the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative period. In both groups, patients will be submitted, functional capacity assessment, flexibility assessment, assessment of the presence of lymphedema, and questionnaire application of fatigue, quality of life, level of physical activity and depression. Will be performed a descriptive analysis of the population. Univariate logistic regression will be performed between the outcomes according to the exercise groups and also, for the possible confounding variables. The variables with p\<0.20 will be selected for adjustment in the construction of the multiple logistic regression model. Those with p\<0.05 and/or with clinical significance will be maintained in the model.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Radiotherapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home exercises | Other | — | UNRESOLVED |
| Pilates Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Patients in this group will be submitted to 10 sessions of Mat Pilates exercises, performed twice a week, lasting 60 minutes, for a period of 5 weeks (from the beginning to the end of radiotherapy). The program will consist of group sessions of up to 4 patients, supervised by a specialized physiotherapist. In addition, they will be guided to follow with the home exercises, according to the institutional routine.
- interventionNames
- Other: Pilates Exercise
- Other: Home exercises
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Patients assigned to this group will not participate in the Mat Pilates exercises and will be instructed to maintain the home exercises for upper limbs, guided by physiotherapists in the postoperative period, according to the institutional routine.
- interventionNames
- Other: Home exercises
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 years and older * Women with indication of adjuvant radiotherapy in the period from March 15, 2017 to May 30, 2019 to be performed exclusively at the Hospital de Cancer III (INCA / HCIII). Exclusion Criteria: * Women who practice physical activity at least 2 times a week for 1 hour * Women with previous cancer diagnosis * Women submitted to immediate breast reconstruction * Presence of acute infections and orthopedic, neurological, decompensated cardiorespiratory and severe renal dysfunction * Women who are not able to respond to questionnaires and not to agree to sign the Informed Consent Form.
References
Publications (1)
- DERIVEDTorres DM, de Menezes Fireman K, Fabro EAN, Thuler LCS, Koifman RJ, Bergmann A, da Silva Santos S. Effectiveness of mat pilates on fatigue in women with breast cancer submitted to adjuvant radiotherapy: randomized controlled clinical trial. Support Care Cancer. 2023 May 30;31(6):362. doi: 10.1007/s00520-023-07824-1. PMID 37249715