- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06859593
Upper Extremity Exercise Capacity Of Breast Cancer
Comparison Of Upper Extremity Exercise Capacity Of Breast Cancer Patients With Healthy Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. While the breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently observed during and/or after breast cancer treatments. Upper extremity lymphedema that develops after breast cancer treatment usually affects the glenohumeral joint by increasing the tension in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. In addition, lymphedema may cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity. Kinesiophobia (fear-avoidance reaction to activity), which may develop in patients in relation to the affected extremity, is another factor in decreased capacity of the upper extremity. Patients may restrict the use of their extremities to prevent aggravation of lymphedema. Decreased functional capacity is common after breast cancer treatment. The '6 Minute Pegboard and Ring Test-6PBRT' is a valid and reliable, useful, practical and easy-to-administer test that evaluates unsupported arm endurance in breast cancer patients, patients with COPD, patients with asthma and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried for 6 minutes is recorded as a score. In a study conducted in patients with mild to very severe COPD, it was shown that there was a positive correlation between the 6PBRT score and activity counts assessed by accelerometry. In addition, the 6PBRT score showed a clear relationship with upper extremity ROM and it was concluded that the 6PBRT test can be used as a suitable test for predicting and demonstrating improvement of ROM in pulmonary rehabilitation programs. Therefore, the aim of this study was to test both arm endurance and arm exercise capacity of patients with breast cancer using the 6PBRT test and to compare them with healthy individuals to understand how much they are affected compared to healthy individuals.
As a secondary aim of the study, it is planned to investigate the relationship between lymph edema severity and anthropometric measurements and upper extremity activities and arm exercise capacity in the group with breast cancer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
State
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Ankara, State, Turkey, 06100
- Hcettepe University, Ankara, State 06100
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Breast Cancer Group:
- Being between 18-65 years of age,
- Volunteering to participate in the research,
- Stage I-III breast cancer,
- At least 15 months after breast cancer surgery,
- Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
- No problems in reading and/or understanding the scales and being able to cooperate with the tests,
Healthy group:
- Age between 18-65 years,
- Volunteering to participate in the research,
- No problems in reading and/or understanding the scales and being able to cooperate with the tests.
Exclusion Criteria:
Breast Cancer Group:
- Presence of active infection,
- Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
- Having a neurological disease or other clinical diagnosis that may affect cognitive status.
Healthy group:
- Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
- Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Cancer Group
Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e.
surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests.
Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.
|
Upper Extremity Exercise Capacity
|
|
Control Group
The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests.
Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.
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Upper Extremity Exercise Capacity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Exercise Capacity
Time Frame: One Year
|
6-Minute Pegboard and Ring Test
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lymphedema Evaluation
Time Frame: One Year
|
Arm circumference measurement
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One Year
|
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Measurement of arm length, arm and forearm circumference
Time Frame: One Year
|
The circumference and length measurements of the participants' dominant and non-dominant arm will be measured using a tape measure
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One Year
|
|
Evaluation of Upper Extremity Functionality
Time Frame: One Year
|
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) The score ranges from 0 to 100.
A higher score reflects more severe upper extremity dysfunction, and the cutoff scores are 0-15 for normal, 16-40 for having problems but working, and more than 40 for being unable to work
|
One Year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Melda Saglam, PhD, Hacettepe University, Ankara, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FTREK 25/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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