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Effects of the Anchor System in the Postural Stability

Primary Purpose

Breast Cancer, Balance; Distorted

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
Elaine Caldeira de Oliveira Guirro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Lymphedema, Postural balance, Falls

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women undergoing treatment for breast cancer, in the 35 to 59 age group with lymphedema, women in the same age group without lymphedema, women in the 60 to 80 age group with lymphedema, and women in the same age group without lymphedema.

Exclusion Criteria:

  • Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.

Sites / Locations

  • Medical School of Ribeirão PretoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

GAJL - Young adult with lymphedema

GAJ - Young adult without lymphedema

GIL - Elderly with lymphedema

GI - Elderly without lymphedema

Arm Description

Women age 35 to 59 years (young adult) with lymphedema - exercise group

Women age 35 to 59 years (young adult) without lymphedema - exercise group

Women aged 60 to 80 years (elderly) with lymphedema - exercise group

Women aged 60 to 80 years (elderly) without lymphedema - exercise group

Outcomes

Primary Outcome Measures

Functional balance
Balance evaluation systems test - BESTest
Accidental falls
Falls efficacy scale international - FES-I
Plantar pressure distribution
Baropodometry system

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 8, 2020
Sponsor
Elaine Caldeira de Oliveira Guirro
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1. Study Identification

Unique Protocol Identification Number
NCT04303221
Brief Title
Effects of the Anchor System in the Postural Stability
Official Title
Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine Caldeira de Oliveira Guirro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the effect of a balance rehabilitation program associated or not with the use of the anchor system, on the postural control of women undergoing breast cancer treatment.
Detailed Description
The aim of this study is to compare the effects of an exercise program associated or not with a non-rigid instrument, called the anchor system, on the postural control of women undergoing breast cancer treatment. For this purpose, 80 women submitted to breast cancer treatment will be invited to participate, divided into four homogeneous groups, determined by the sample calculation: women submitted to breast cancer treatment in the age group of 35 to 59 years (young adult) with lymphedema (GAJL), women in the same age group without lymphedema (GAJ), women in the age group 60 to 80 years (elderly) with lymphedema (GIL), and women in the same age group without lymphedema (GI). Cognitive status will be assessed by the Mini Mental State Examination. To assess the subsystems responsible for maintaining balance, the Balance Evaluation Systems Test (BESTest) will be used, presented in order to guide clinical intervention, in addition to the Falls Efficacy Scale -International (FES-I). The distribution of plantar pressure and balance will be assessed using baropodometry. For data analysis, a normality test and data distribution will be performed, in addition to a statistical test consistent with the appropriate intra and intergroup comparisons, with a significance level of 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Balance; Distorted
Keywords
Breast cancer, Lymphedema, Postural balance, Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GAJL - Young adult with lymphedema
Arm Type
Experimental
Arm Description
Women age 35 to 59 years (young adult) with lymphedema - exercise group
Arm Title
GAJ - Young adult without lymphedema
Arm Type
Experimental
Arm Description
Women age 35 to 59 years (young adult) without lymphedema - exercise group
Arm Title
GIL - Elderly with lymphedema
Arm Type
Experimental
Arm Description
Women aged 60 to 80 years (elderly) with lymphedema - exercise group
Arm Title
GI - Elderly without lymphedema
Arm Type
Experimental
Arm Description
Women aged 60 to 80 years (elderly) without lymphedema - exercise group
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.
Primary Outcome Measure Information:
Title
Functional balance
Description
Balance evaluation systems test - BESTest
Time Frame
5 minutes
Title
Accidental falls
Description
Falls efficacy scale international - FES-I
Time Frame
5 minutes
Title
Plantar pressure distribution
Description
Baropodometry system
Time Frame
10 minuntes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women undergoing treatment for breast cancer, in the 35 to 59 age group with lymphedema, women in the same age group without lymphedema, women in the 60 to 80 age group with lymphedema, and women in the same age group without lymphedema. Exclusion Criteria: Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine C Guirro, PhD
Phone
(16)33150215
Email
ecguirro@fmrp.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Flávia B Rangon
Phone
(16)33150215
Email
flavia.rangon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Guirro, PhD
Organizational Affiliation
University of Sao Paulo - Ribeirao Preto - Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine C Guirro, Ph. D
Phone
551636024584
Email
ecguirro@fmrp.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of the Anchor System in the Postural Stability

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