Effect of BOSU Exercises Added to Complete Decongestive Treatment on

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06182046
Study type	Interventional
Source	Pamukkale University
Contact	Esra Karaköseli
Phone	+905395765952
Email	esra.karakoseli@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2024
Completion date	July 1, 2025

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See also
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Completed	`NCT04881604` - Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	N/A
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Terminated	`NCT04073823` - A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients	N/A
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Completed	`NCT04659564` - Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms