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

NCT06182046 | Unknown

• 1 other identifier: PamukkaleU-Karaköseli-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Related Lymphedema

Keywords

BOSU Ball; Lymphedema; Balance

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (16)

• Arm circumference measurements

  1 day before rehabilitation

• Arm circumference measurements

  3 weeks after the start of rehabilitation

• Arm volumetric measurements

  1 day before rehabilitation

• Arm volumetric measurements

  3 weeks after the start of rehabilitation

• Fall Activity Scale

  1 day before rehabilitation

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Complete decongestive treatment program; Procedure: Balance exercises

Active Control group: Complete decongestive treatment

ACTIVE COMPARATOR

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.

Procedure: Complete decongestive treatment program

Interventions

Complete decongestive treatment program PROCEDURE

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.

Active Control group: Complete decongestive treatment; Intervention group: Balance exercise with BOSU Ball added to complete decongestive treatment

Balance exercises PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oya Topuz: lead

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oya Topuz

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Esra Karaköseli

CONTACT

+905395765952; esra.karakoseli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share