Effects of the Anchor System in the Postural Stability

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303221
• Other study ID #: 3474028/2019
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2020
• Source: University of Sao Paulo
• Contact: Elaine C Guirro, PhD
• Phone: (16)33150215
• Email: ecguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance; Distorted
• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Exercise
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.

Locations

Country	Name	City	State
Brazil	Medical School of Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Elaine Caldeira de Oliveira Guirro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional balance	Balance evaluation systems test - BESTest	5 minutes
Primary	Accidental falls	Falls efficacy scale international - FES-I	5 minutes
Primary	Plantar pressure distribution	Baropodometry system	10 minuntes