Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy

NCT03333993 | Completed

• 1 other identifier: 64099717.7.0000.5274
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Adjuvant Radiotherapy

Keywords

Pilates exercise; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fatigue

  It will be assessed by FACIT-FATIGUE (Version 4) questionnaire.

  2 years

Secondary Outcomes (5)

• Quality of Life in breast cancer

  2 years

• Functionality

  2 years

• Depression

  2 years

• Quality of life related to health

  2 years

• Physical activity level

  2 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Pilates Exercise; Other: Home exercises

Control Group

ACTIVE COMPARATOR

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.

Other: Home exercises

Interventions

Pilates Exercise OTHER

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.

Also known as: Pilates method

Intervention Group

Home exercises OTHER

Exercises for upper limbs according to the institutional routine.

Also known as: Institutional Routine

Control Group; Intervention 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Daniele Medeiros Torres

Rio de Janeiro, 20521060, Brazil

Location

Related Publications (1)

• Torres 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Daniele Torres, master

  National Cancer Institute, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 7, 2017
• Study Start: March 15, 2017
• Primary Completion: May 30, 2019
• Study Completion: December 10, 2019
• Last Updated: April 15, 2021

Record last verified: 2019-11

Locations

BR (1)