Effects of the Anchor System in the Postural Stability

Not Applicable

• Conditions: Balance; Distorted; Breast Cancer
• Interventions: Other: Exercise

• Registration Number: NCT04303221
• Lead Sponsor: Elaine Caldeira de Oliveira Guirro

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%.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-08
• Last Update Submitted: 2020-03-08
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Primary Completion: 2022-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIL - Elderly with lymphedema	Exercise	Women aged 60 to 80 years (elderly) with lymphedema - exercise group
GAJL - Young adult with lymphedema	Exercise	Women age 35 to 59 years (young adult) with lymphedema - exercise group
GI - Elderly without lymphedema	Exercise	Women aged 60 to 80 years (elderly) without lymphedema - exercise group
GAJ - Young adult without lymphedema	Exercise	Women age 35 to 59 years (young adult) without lymphedema - exercise group

Primary Outcome Measures

Name	Time	Method
Functional balance	5 minutes	Balance evaluation systems test - BESTest
Accidental falls	5 minutes	Falls efficacy scale international - FES-I
Plantar pressure distribution	10 minuntes	Baropodometry system

Trial Locations

Locations (1)

Medical School of Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil