Balance and Physical Activity Deficits After Breast SurgeryNCT05566509
Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer
An observational study of Balance and Physical Activity Deficits After Breast Surgery, run by Saglik Bilimleri Universitesi.
Trial summary
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Balance and Physical Activity Deficits After Breast Surgery
- What is being tested?
- Breast excision
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: breast cancer
Who may be able to join
- patients who had breast cancer surgery
Who cannot join
- balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease), bone metastasis, patients who have undergone reconstructive surgery
About this study
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed.
- Being tested
- Breast excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast excisionProcedure or surgery
some patient had minimal excision, some had maximal excision.
| Study group | Role | What they receive |
|---|---|---|
| Breast Conservative Surgery | The patients who had minimally invasive surgery. Receives: Procedure: Breast excision | |
| Mastectomy | The patients who had invasive and destructive surgery. Receives: Procedure: Breast excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in the physical activity
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer.
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance and Physical Activity Deficits After Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566509
- Sponsor's protocol ID
- SaglikBilimleriUEZBERCI
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer
- ClinicalTrials.gov ID
- NCT05566509
- Acronym / sponsor ID
- SaglikBilimleriUEZBERCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Oct 2022 (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.
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Conservative Surgery | – | Procedure: Breast excisionThe patients who had minimally invasive surgery. |
| Mastectomy | – | Procedure: Breast excisionThe patients who had invasive and destructive surgery. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- breast cancer
Key inclusion criteria (1 listed)
- patients who had breast cancer surgery
Key exclusion criteria (1 listed)
- balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease), bone metastasis, patients who have undergone reconstructive surgery
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 |
|---|---|---|
| Breast excisionsome patient had minimal excision, some had maximal excision. | Procedure or surgery | Breast Conservative Surgery, Mastectomy |
Primary outcome
decrease in the physical activity
Time frame: 2
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer.
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 4 Oct 2022.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Balance and Physical Activity Deficits After Breast Surgery, run by Saglik Bilimleri Universitesi.
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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
decrease in the physical activity (time frame: 2). 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 4 Oct 2022.