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

Breast Cancer Related Lymphedema Clinical Trial

Official title:

The Effect of BOSU Ball Balance Exercises Added to Complete Decongestive Treatment on Static and Dynamic Balance in Breast Cancer-associated Lymphedema.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182046
• Other study ID #: PamukkaleU-Karaköseli-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: December 2023
• Source: Pamukkale University
• Contact: Esra Karaköseli
• Phone: +905395765952
• Email: esra.karakoseli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• Complete decongestive treatment program
It 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.
• Balance exercises
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oya Topuz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static balance measurements	The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the center of pressure path length and the area over which the center of pressure moves. Smaller values indicate greater stability and balance ability in the lower extremities.	1 day before rehabilitation
Primary	Static balance measurements	The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the center of pressure path length and the area over which the center of pressure moves. Smaller values indicate greater stability and balance ability in the lower extremities.	3 weeks after the start of rehabilitation
Primary	Dynamic balance measurements	The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the average track error and stability index.	1 day before rehabilitation
Primary	Dynamic balance measurements	The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on the average track error and stability index.	3 weeks after the start of rehabilitation
Secondary	Arm circumference measurements	Arm-hand circumference measurements will be made with a tape measure at four points: metacarpal circumference, wrist, 10 cm below the lateral epicondyle and 15 cm above the lateral epicondyle. The measurement will be made on both upper extremities and the difference between them will be recorded.	1 day before rehabilitation
Secondary	Arm circumference measurements	Arm-hand circumference measurements will be made with a tape measure at four points: metacarpal circumference, wrist, 10 cm below the lateral epicondyle and 15 cm above the lateral epicondyle. The measurement will be made on both upper extremities and the difference between them will be recorded.	3 weeks after the start of rehabilitation
Secondary	Arm volumetric measurements	Arm-hand volume measurements will be made with the help of a water displacement volumeter. After placing a mark 15 cm below the acromioclavicular joint from the anterior on both arms of the patients, they will be dipped into the volumeter one by one up to this level and the overflowing water will be measured.	1 day before rehabilitation
Secondary	Arm volumetric measurements	Arm-hand volume measurements will be made with the help of a water displacement volumeter. After placing a mark 15 cm below the acromioclavicular joint from the anterior on both arms of the patients, they will be dipped into the volumeter one by one up to this level and the overflowing water will be measured.	3 weeks after the start of rehabilitation
Secondary	Fall Activity Scale	It is a 10-item scale. Each question is given a score between 1 (not completely safe) and 10 (very safe), with the total score ranging from 0 to 100. As the score increases, the fear of falling decreases.	1 day before rehabilitation
Secondary	Fall Activity Scale	It is a 10-item scale. Each question is given a score between 1 (not completely safe) and 10 (very safe), with the total score ranging from 0 to 100. As the score increases, the fear of falling decreases.	3 weeks after the start of rehabilitation
Secondary	Tampa Kinesiophobia Scale	It is a checklist of 17 questions. 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale. The person receives a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia.	1 day before rehabilitation
Secondary	Tampa Kinesiophobia Scale	It is a checklist of 17 questions. 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale. The person receives a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia.	3 weeks after the start of rehabilitation
Secondary	Fullerton Advanced Balance Scale	The FAB scale was developed to assess subtle changes in many dimensions of balance. This performance-based scale consists of 10 test items that assess functional balance status in older people. Each test item is scored using a scale of 0-4. The person receives a total score between 0-40. Higher scores indicate better balance ability.	1 day before rehabilitation
Secondary	Fullerton Advanced Balance Scale	The FAB scale was developed to assess subtle changes in many dimensions of balance. This performance-based scale consists of 10 test items that assess functional balance status in older people. Each test item is scored using a scale of 0-4. The person receives a total score between 0-40. Higher scores indicate better balance ability.	3 weeks after the start of rehabilitation
Secondary	Timed Up and Go Test	It is a balance test commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires the subject to stand, walk 3 m, turn and walk backwards, and sit down. Older adults who can complete the task in less than 20 seconds have better balance. In contrast, older adults who require 30 seconds or more to complete the task have worse balance.	1 day before rehabilitation
Secondary	Timed Up and Go Test	It is a balance test commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires the subject to stand, walk 3 m, turn and walk backwards, and sit down. Older adults who can complete the task in less than 20 seconds have better balance. In contrast, older adults who require 30 seconds or more to complete the task have worse balance.	3 weeks after the start of rehabilitation
Secondary	Quality of Life Measurement ULL-27	ULL-27 quality of life questionnaire, developed specifically for upper extremity lymphedema patients. The scale has physical, psychological and social dimensions. It consists of 27 questions. A high score on the scale indicates that lymphedema negatively affects the quality of life.	1 day before rehabilitation
Secondary	Quality of Life Measurement ULL-27	ULL-27 quality of life questionnaire, developed specifically for upper extremity lymphedema patients. The scale has physical, psychological and social dimensions. It consists of 27 questions. A high score on the scale indicates that lymphedema negatively affects the quality of life.	3 weeks after the start of rehabilitation
Secondary	Hospital Anxiety and Depression Scale	The scale is used to determine the risk of anxiety and depression in the patient and to measure its level and change in severity. The scale consists of a total of 14 questions. The items in the scale are evaluated on a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as not sick, 2 is considered as borderline sick, and 2-3 is considered as seriously ill. The total scores of the subscales are obtained by adding these item scores.	1 day before rehabilitation
Secondary	Hospital Anxiety and Depression Scale	The scale is used to determine the risk of anxiety and depression in the patient and to measure its level and change in severity. The scale consists of a total of 14 questions. The items in the scale are evaluated on a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as not sick, 2 is considered as borderline sick, and 2-3 is considered as seriously ill. The total scores of the subscales are obtained by adding these item scores.	3 weeks after the start of rehabilitation