Effects of the Anchor System in the Postural Stability

Study Overview
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Brief Summary
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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
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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%.

Official Title
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Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer

Conditions
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Breast Cancer, Balance; Distorted

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAJL - Young adult with lymphedema<br>Women age 35 to 59 years (young adult) with lymphedema - exercise group | Other: Exercise<br>* 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.<br>|
| Experimental: GAJ - Young adult without lymphedema<br>Women age 35 to 59 years (young adult) without lymphedema - exercise group | Other: Exercise<br>* 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.<br>|
| Experimental: GIL - Elderly with lymphedema<br>Women aged 60 to 80 years (elderly) with lymphedema - exercise group | Other: Exercise<br>* 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.<br>|
| Experimental: GI - Elderly without lymphedema<br>Women aged 60 to 80 years (elderly) without lymphedema - exercise group | Other: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional balance | Balance evaluation systems test - BESTest | 5 minutes | 
| Accidental falls | Falls efficacy scale international - FES-I | 5 minutes | 
| Plantar pressure distribution | Baropodometry system | 10 minuntes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Lymphedema, Postural balance, Falls