- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05303675
The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery
The Effect of Education, Lymphedema Risk Scoring, and Progressive Upper Extremity Exercises on Strengthening the Self-care Skills of Women Who Have Breast Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Melikgazi
-
Kayseri̇, Melikgazi, Turkey, 38260
- Recruiting
- Erciyes University
-
Contact:
- Gülseren Maraş, Ress. Assist.
- Phone Number: 28557 +90 352 207 6666
- Email: gulserenmaras@erciyes.edu.tr
-
Contact:
- Yeliz Sürme, Dr.
- Phone Number: 28567 +90 352 207 6666
- Email: yelizsurme@erciyes.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female gender,
- Between 18-65 years old
- BMI ≤30 kg/m2
- Axillary lymph node dissection (removal of at least 2 lymph nodes),
- No history of cancer other than breast cancer,
- Does not have any chronic disease (such as diabetes mellitus, hypertension, chronic obstructive pulmonary disease) that prevents exercise
- No previous diagnosis of lymphedema,
- Not pregnant or breastfeeding during the study,
- Individuals who agree to participate in the study will be included in the study.
Exclusion Criteria:
- Total (simple) mastectomy,
- History of bilateral lymph node dissection,
- Lymphedema (difference >2 cm with an intact extremity)
- Individuals who do not agree to participate in the study will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Preoperative: An introductory information form will be filled out, and a lymphedema self-care and exercise booklet will be given. Postoperative: Patients will be applied Progressive Upper Limb Exercises and Muscle Relaxation Training (PULE-MRT), lymphedema upper extremity circumference measurement, and symptom alert model until discharge, and Muscle Relaxation Training will continue until discharge. Post-Discharge: They will be asked to record a diary at home. PULE-MRT will continue until day 15. The 15-day exercise program will continue for up to 3 months. Follow-up will be made by telephone according to the symptom alert model at the 1st, 2nd, and 3rd months, and at the end of the 3rd month, the breast cancer-related lymphedema self-care scale will be administered. |
Preoperative: An introductory information form will be filled out, and a lymphedema self-care and exercise booklet will be given. Postoperative: Patients will be applied Progressive Upper Limb Exercises and Muscle Relaxation Training (PULE-MRT), lymphedema upper extremity circumference measurement, and symptom alert model until discharge, and Muscle Relaxation Training will continue until discharge. Post-Discharge: They will be asked to record a diary at home. PULE-MRT will continue until day 15. The 15-day exercise program will continue for up to 3 months. Follow-up will be made by telephone according to the symptom alert model at the 1st, 2nd, and 3rd months, and at the end of the 3rd month, the breast cancer-related lymphedema self-care scale will be administered. |
No Intervention: Control Group
Preoperative: Introductory information form will be filled out. Postoperative: Standard nursing care will be applied to the patients, lymphedema upper extremity circumference measurement and symptom alert model follow-up form will be applied. Post-Discharge: Lymphedema upper extremity circumference measurement will be explained to the patients before discharge, and they will be asked to record the 1st, 2nd, and 3rd months at home. Patients will be followed up by telephone according to the symptom alert model at the 1st, 2nd, and 3rd months, and at the end of the 3rd month, the breast cancer-related lymphedema self-care scale will be administered. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
arm circumference measurement
Time Frame: 1st month
|
Change from baseline in arm circumference at 1 month.
Arm circumference measurement:An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
|
1st month
|
arm circumference measurement
Time Frame: 2nd month
|
Change from baseline in arm circumference at 2 month.
Arm circumference measurement: An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
|
2nd month
|
arm circumference measurement
Time Frame: 3nd month
|
Change from baseline in arm circumference at 3 month.
Arm circumference measurement: An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
|
3nd month
|
lymphedema symptom
Time Frame: 1rd month
|
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 1-month.
'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components.
Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
|
1rd month
|
lymphedema symptom
Time Frame: 2rd month
|
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 2-month.
'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components.
Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
|
2rd month
|
lymphedema symptom
Time Frame: 3rd month
|
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 3-month.
'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components.
Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
|
3rd month
|
self-care
Time Frame: 3rd month
|
The number of participants with a high self-care score according to the 'Breast Cancer-Related Lymphedema Self-Care Scale'.
'Breast Cancer-Related Lymphedema Self-Care Scale': The lowest 31, the highest 124 points are taken from the scale.
Higher scores indicate better self-care.
|
3rd month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 710/2021
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
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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