Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-associated Lymphedema.

Oya Topuz

Status: Not yet enrolling

Conditions: Breast Cancer Related Lymphedema

Treatments: Procedure: Complete decongestive treatment program; Procedure: Balance exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06182046

PamukkaleU-Karaköseli-001

Details and patient eligibility

About

The aim of the study is to investigate the effect of balance exercises performed with the BOSU ball added to complete decongestive treatment on static and dynamic balance in patients with breast cancer-related lymphedema.

Full description

The study was planned as a randomized controlled study. The patients who had unilateral breast cancer-associated lymphedema according to the 2020 diagnostic criteria of the International Society of Lymphology for at least six months and met the inclusion and exclusion criteria will be randomly divided into 2 groups.

The trial will be carried out at Pamukkale University Department of Physical Medicine and Rehabilitation PAUTERM between December 2023 and June 2025. The local ethics committee approved the study. All women will be informed about the purpose and content of the study and all women will sign written consent to participate in the study.

Group1: Group receiving balance exercise with BOSU Ball added to complete decongestive treatment (Intervention group) Complete decongestive treatment program consists of manual lymph drainage, multi-layer bandaging, skin/nail care and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks. Patients in the intervention group will also receive balance exercises with a BOSU ball. These exercises will be performed in 2 sets, 5 days a week for 3 weeks. Each set will last 15 minutes. It will take 15 sessions in total. These exercises include 10 balance exercise movements performed on a bosu ball.

Group 2: Group receiving complete decongestive treatment (Active control group) Patients in this group will receive only a complete decongestive treatment program consisting manual lymph drainage, multilayer bandaging, skin/nail care, and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks.

All patients will be evaluated with the following evaluation parameters before the treatment and at the time of discharge.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female gender
• Patients aged 18-65 years
• Having a history of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer diagnosis.
• Having unilateral breast cancer-related upper extremity lymphedema (>20% volume difference between the two upper extremities) according to the diagnostic criteria of the - International Society of Lymphology (Committee 2020) for at least six months.
• Not having received lymphedema treatment or exercise therapy for the last six months
• Completing breast cancer primary treatment at least 6 months ago (except hormone therapy/aromatase inhibitors)

Exclusion criteria

• Bilateral breast cancer
• Bilateral axillary lymph node dissection
• Metastatic breast cancer
• Receiving ongoing radiotherapy or chemotherapy
• Primary or bilateral lymphedema
• Having active cancer
• Presence of stage 3 lymphedema
• Uncontrolled serious systemic disease (cardiopulmonary diseases, arterial or venous diseases, renal dysfunction, uncontrolled hypertension or hypotension).
• Active or previous infection in the last 3 months (cellulitis, lymphangitis)
• Presence of open wounds
• Having any problems that may affect balance (vestibular, visual, neurological or orthopedic diseases)
• Using medications that may affect body fluid and electrolyte balance (diuretics, etc.).
• Individuals with serious mental and sensory problems
• History of spine surgery in the last 6 months
• Being pregnant
• Body mass index >40 kg/m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention group: Balance exercise with BOSU Ball added to complete decongestive treatment

Experimental group

Description:

Complete decongestive treatment program consists of manual lymph drainage, multi-layer bandaging, skin/nail care and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks. Patients in the intervention group will also receive balance exercises with a BOSU ball. These exercises will be performed in 2 sets, 5 days a week for 3 weeks. Each set will last 15 minutes. It will take 15 sessions in total. These exercises include 10 balance exercise movements performed on a bosu ball.

Treatment:

Procedure: Complete decongestive treatment program

Procedure: Balance exercises

Active Control group: Complete decongestive treatment

Active Comparator group

Description:

Patients in this group will receive only a complete decongestive treatment program consisting manual lymph drainage, multilayer bandaging, skin/nail care, and exercise treatments. The treatment will last 45 minutes/session, 5 sessions/week and 3 weeks.

Treatment:

Procedure: Complete decongestive treatment program