Breast Neoplasm FemaleNCT03826979
PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY
A study testing Pliates method treatment in people with Breast Neoplasm Female, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Pliates method treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2018to 30 Jan 2019
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days
Who cannot join
- Women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY OF THE MASTECTOMIZED WOMEN
INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels.
OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy.
Read more
METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained.
CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.
- Conditions
- Breast Neoplasm Female
- Being tested
- Pliates method treatment
- Keywords
- Breast cancer., Exercise Therapy, Modified Radical Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pliates method treatmentOther
The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Pilates treatment | Experimental | The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months. Receives: Other: Pliates method treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Medical Research Council scale for muscle power
Measured: 2 months
Range of motion
Range of motion evaluation by goniometry
Measured: 2 months
Functionality assess with Functional independence measure scale
Functional independence measure scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 May 2018
- Primary completion1 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael do Nascimento Pereira, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826979
- Sponsor's protocol ID
- 2.510.081
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY OF THE MASTECTOMIZED WOMEN
- ClinicalTrials.gov ID
- NCT03826979
- Acronym / sponsor ID
- 2.510.081
- Conditions
- Breast Neoplasm Female
- Keywords
- Breast cancer., Exercise Therapy, Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 1 Feb 2019 (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.
INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels.
OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy.
METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained.
CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
| Arm | Type | Receives |
|---|---|---|
| Pilates treatment | Experimental | Other: Pliates method treatmentThe participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days
Key exclusion criteria (1 listed)
- Women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.
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 |
|---|---|---|
| Pliates method treatmentThe participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months. | Other | Pilates treatment |
Primary outcome
Muscle strength
Time frame: 2 months
Medical Research Council scale for muscle power
Range of motion
Time frame: 2 months
Range of motion evaluation by goniometry
Functionality assess with Functional independence measure scale
Time frame: 2 months
Functional independence measure scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pliates method treatment in people with Breast Neoplasm Female, run by Universidade Metodista de Piracicaba 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: finished, as of the sponsor's last update on 1 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 2 months). 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?
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 1 Feb 2019.