The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303675
• Other study ID #: 710/2021
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2023
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• exercise and training
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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri?	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
Gulseren MARAS

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arm circumference measurement	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
Primary	arm circumference measurement	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
Primary	arm circumference measurement	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
Primary	lymphedema symptom	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
Primary	lymphedema symptom	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
Primary	lymphedema symptom	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
Primary	self-care	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