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Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy

NCT03333993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-04-15

No results posted yet for this study

Summary

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

Interventions

OTHER

Pilates Exercise

The Mat Pilates exercise will be performed twice a week and the duration of the sessions will be 60 minutes, consisting of 5 minutes of warm-up exercises, 50 minutes of strengthening exercises followed by 5 minutes of relaxation and stretching.

OTHER

Home exercises

Exercises for upper limbs according to the institutional routine.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Daniele Torres, master · National Cancer Institute, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2019-05-30
Completion
2019-12-10

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333993 on ClinicalTrials.gov