Breast CancerNCT04303221
Effects of the Anchor System in the Postural Stability
A study testing Exercise in people with Breast Cancer and Balance; Distorted, run by Elaine Caldeira de Oliveira Guirro at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Balance; Distorted
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2020to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
Elaine C Guirro, Ph. D, 551636024584, ecguirro@fmrp.usp.br
About this study
Official title: Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer
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.
Read the 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
- Being tested
- Exercise
- Keywords
- Breast cancer, Lymphedema, Postural balance, Falls
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GAJL - Young adult with lymphedema | Experimental | Women age 35 to 59 years (young adult) with lymphedema - exercise group Receives: Other: Exercise |
| GAJ - Young adult without lymphedema | Experimental | Women age 35 to 59 years (young adult) without lymphedema - exercise group Receives: Other: Exercise |
| GIL - Elderly with lymphedema | Experimental | Women aged 60 to 80 years (elderly) with lymphedema - exercise group Receives: Other: Exercise |
| GI - Elderly without lymphedema | Experimental | Women aged 60 to 80 years (elderly) without lymphedema - exercise group Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional balance
Balance evaluation systems test - BESTest
Measured: 5 minutes
Accidental falls
Falls efficacy scale international - FES-I
Measured: 5 minutes
Plantar pressure distribution
Baropodometry system
Measured: 10 minuntes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elaine Caldeira de Oliveira Guirro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
- Investigators
- Elaine Guirro, PhD, Principal investigator, University of Sao Paulo - Ribeirao Preto - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303221
- Sponsor's protocol ID
- 3474028/2019
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37499853
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT04303221
- Acronym / sponsor ID
- 3474028/2019
- Conditions
- Breast Cancer, Balance; Distorted
- Keywords
- Breast cancer, Lymphedema, Postural balance, Falls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Elaine Caldeira de Oliveira GuirroUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GAJL - Young adult with lymphedema | Experimental | Other: ExerciseWomen age 35 to 59 years (young adult) with lymphedema - exercise group |
| GAJ - Young adult without lymphedema | Experimental | Other: ExerciseWomen age 35 to 59 years (young adult) without lymphedema - exercise group |
| GIL - Elderly with lymphedema | Experimental | Other: ExerciseWomen aged 60 to 80 years (elderly) with lymphedema - exercise group |
| GI - Elderly without lymphedema | Experimental | Other: ExerciseWomen aged 60 to 80 years (elderly) without lymphedema - exercise group |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | GAJ - Young adult without lymphedema, GAJL - Young adult with lymphedema, GI - Elderly without lymphedema, GIL - Elderly with lymphedema |
Primary outcome
Functional balance
Time frame: 5 minutes
Balance evaluation systems test - BESTest
Accidental falls
Time frame: 5 minutes
Falls efficacy scale international - FES-I
Plantar pressure distribution
Time frame: 10 minuntes
Baropodometry system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 37499853Rangon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Guirro, PhD principal investigator
University of Sao Paulo - Ribeirao Preto - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer and Balance; Distorted, run by Elaine Caldeira de Oliveira Guirro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine C Guirro, PhD ((16)33150215, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional balance (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.