NCT03826979

Brief Summary

INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels. OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy. METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained. CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 31, 2019

Last Update Submit

January 31, 2019

Conditions

Keywords

Breast cancer.Exercise TherapyModified Radical Mastectomy

Outcome Measures

Primary Outcomes (3)

  • Muscle strength

    Medical Research Council scale for muscle power

    2 months

  • Range of motion

    Range of motion evaluation by goniometry

    2 months

  • Functionality assess with Functional independence measure scale

    Functional independence measure scale

    2 months

Study Arms (1)

Pilates treatment

EXPERIMENTAL

The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.

Other: Pliates method treatment

Interventions

The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.

Pilates treatment

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen in post-operative radical-mastectomy treatment.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days

You may not qualify if:

  • Women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raphael Pereira

Belém, Pará, 66060-585, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Raphael do Nascimento Pereira

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 1, 2019

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 30, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations