Effects of the Anchor System in the Postural Stability

NCT ID: NCT04303221

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-03-01

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%.

Conditions

Breast Cancer; Balance; Distorted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAJL - Young adult with lymphedema

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

GAJ - Young adult without lymphedema

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

GIL - Elderly with lymphedema

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

GI - Elderly without lymphedema

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Elaine Caldeira de Oliveira Guirro

OTHER

Sponsor Role: lead

Responsible Party

Elaine Caldeira de Oliveira Guirro

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elaine Guirro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo - Ribeirao Preto - Brazil

Locations

Medical School of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Elaine C Guirro, PhD

Role: CONTACT

ecguirro@fmrp.usp.br

(16)33150215

Flávia B Rangon

Role: CONTACT

flavia.rangon@gmail.com

(16)33150215

Facility Contacts

Elaine C Guirro, Ph. D

Role: primary

ecguirro@fmrp.usp.br

551636024584

References

Rangon FB, Marinho IL, Cuviena CF, de Moraes R, de Jesus Guirro RR, de Oliveira Guirro EC. Effects of the Anchor System on Postural Balance of Women Undergoing Breast Cancer Treatment: A Clinical, Randomized, Controlled, and Crossover Trial. Arch Phys Med Rehabil. 2024 Feb;105(2):258-267. doi: 10.1016/j.apmr.2023.07.005. Epub 2023 Jul 25.

Reference Type: DERIVED

PMID: 37499853 (View on PubMed)

Other Identifiers

3474028/2019

Identifier Type: -

Identifier Source: org_study_id