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

NCT ID: NCT05303675

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2024-10-30

Brief 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.

Conditions

Breast Cancer Female; Breast Cancer Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

exercise and training

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gulseren MARAS

OTHER

Sponsor Role: lead

Responsible Party

Gulseren MARAS

Research Assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

710/2021

Identifier Type: -

Identifier Source: org_study_id