- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566509
Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer
September 30, 2022 updated by: Saglik Bilimleri Universitesi
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
112
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
breast cancer
Description
Inclusion Criteria:
- patients who had breast cancer surgery
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Conservative Surgery
The patients who had minimally invasive surgery.
|
some patient had minimal excision, some had maximal excision.
|
|
Mastectomy
The patients who had invasive and destructive surgery.
|
some patient had minimal excision, some had maximal excision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
decrease in the physical activity
Time Frame: 2
|
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer.
|
2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- SaglikBilimleriUEZBERCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.