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

NCT05303675 | Completed

• 1 other identifier: 710/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; lymphedema; risk scoring; exercise; self-care

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: exercise and training

Control Group

NO INTERVENTION

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.

Interventions

exercise and training 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female gender, breast cancer surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulseren MARAS: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: April 18, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 30, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)