Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy

April 12, 2021 updated by: Instituto Nacional de Cancer, Brazil

Randomized Trial With Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After recruitment, women will be randomly assigned to: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). At 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). The Mat Pilates program will be based on group sessions with the supervision of physiotherapists specialized in technique. The groups will consist of a maximum of 4 patients, to achieve the basic principles of the technique that include concentration, control, accuracy and fluidity of movement. Mat Pilates sessions will be held in the physiotherapy gymnasium of Cancer Hospital III / INCA. The Mat Pilates program will be held twice a week and the duration of sessions will be 60 minutes, consisting of 5 minutes of exercises 50 minutes of strengthening exercises with flexibilization of the muscular fibers, where the concentric phase of the movement will be performed at the expiration, followed by 5 minutes of relaxation and stretching. The movements will be carried out slowly and with the maximum of 2 sets of 10 replicates. The Swiss ball and elastic band accessories will be used. The Mat Pilates intensity exercises will be controlled by means of the adapted Borg Scale (0-10), where the perception of the effort will vary from 2 (very light) to 7 (moderate-intense). On days of the week in which the patient will not practice the Mat Pilates program, the usual upper limb exercises will be maintained by the physiotherapists on the first postoperative day at Cancer Hospital III / INCA. Patients allocated to the control group will not participate in the Mat Pilates program, but will be directed to maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative. In both groups, the patients will be submitted, the functional capacity evaluation composed of the Disability Arm, Shoulder and Hand (DASH) questionnaire, flexibility assessment, presence of lymphedema, radiodermatitis and application of the questionnaires International Questionnaire of Physical Activity (IPAQ), Functional Assessment of Cancer Therapy- Fatigue (FACT-F) for Fatigue, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (EORTC QLQ-C30) and specific module EORTC QLQ Breast-23 (EORTC QLQ-BR23) for quality of life, and Geriatric Depression Scale(GDS) for depression at the time of study inclusion and in the follow-up (end of radiotherapy, 30 days and 6 months after end).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20521060
        • Daniele Medeiros Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
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
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 Names:
  • Pilates method
Other: Home exercises
Exercises for upper limbs according to the institutional routine.
Other Names:
  • Institutional Routine
Active Comparator: Control Group
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
Exercises for upper limbs according to the institutional routine.
Other Names:
  • Institutional Routine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 2 years
It will be assessed by FACIT-FATIGUE (Version 4) questionnaire.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life in breast cancer
Time Frame: 2 years
It will be measured by EORTC QLQ - BR23 questionnaire.
2 years
Functionality
Time Frame: 2 years
It will be evaluated by Brazilian DASH questionnaire.
2 years
Depression
Time Frame: 2 years
This outcome will be measured by GDS-15 questionnaire.
2 years
Quality of life related to health
Time Frame: 2 years
It will be measured by EORTC QLQ- C30 questionnaire.
2 years
Physical activity level
Time Frame: 2 years
It will be measured by IPAQ questionnaire.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Nacional de Cancer, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniele Torres, master, National Cancer Institute, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 64099717.7.0000.5274

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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