Clinical trial NCT06182046: Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-associated Lymphedema.
Official title: The Effect of BOSU Ball Balance Exercises Added to Complete Decongestive Treatment on Static and Dynamic Balance in Breast Cancer-associated Lymphedema.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Keywords: BOSU Ball
Lymphedema
Balance
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Static balance measurements
timeFrame: 1 day before rehabilitation
measure: Static balance measurements
timeFrame: 3 weeks after the start of rehabilitation
measure: Dynamic balance measurements
timeFrame: 1 day before rehabilitation
measure: Dynamic balance measurements
timeFrame: 3 weeks after the start of rehabilitation
Secondary outcomes:
measure: Arm circumference measurements
timeFrame: 1 day before rehabilitation
measure: Arm circumference measurements
timeFrame: 3 weeks after the start of rehabilitation
measure: Arm volumetric measurements
timeFrame: 1 day before rehabilitation
measure: Arm volumetric measurements
timeFrame: 3 weeks after the start of rehabilitation
measure: Fall Activity Scale
timeFrame: 1 day before rehabilitation
measure: Fall Activity Scale
timeFrame: 3 weeks after the start of rehabilitation
measure: Tampa Kinesiophobia Scale
timeFrame: 1 day before rehabilitation
measure: Tampa Kinesiophobia Scale
timeFrame: 3 weeks after the start of rehabilitation
measure: Fullerton Advanced Balance Scale
timeFrame: 1 day before rehabilitation
measure: Fullerton Advanced Balance Scale
timeFrame: 3 weeks after the start of rehabilitation
measure: Timed Up and Go Test
timeFrame: 1 day before rehabilitation
measure: Timed Up and Go Test
timeFrame: 3 weeks after the start of rehabilitation
measure: Quality of Life Measurement ULL-27
timeFrame: 1 day before rehabilitation
measure: Quality of Life Measurement ULL-27
timeFrame: 3 weeks after the start of rehabilitation
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 day before rehabilitation
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 weeks after the start of rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: Oya Topuz
role: STUDY_DIRECTOR
References: