Breast Cancer Related LymphedemaNCT06182046
Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-associated Lymphedema.
A study testing Complete decongestive treatment program and Balance exercises in people with Breast Cancer Related Lymphedema, run by Oya Topuz.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Complete decongestive treatment program and Balance exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Bilateral breast cancer
- Bilateral axillary lymph node dissection
- Metastatic breast cancer
- Receiving ongoing radiotherapy or chemotherapy
- Primary or bilateral lymphedema
- Having active cancer
Show all 16Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of BOSU Ball Balance Exercises Added to Complete Decongestive Treatment on Static and Dynamic Balance in Breast Cancer-associated Lymphedema.
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.
Read the 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.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Complete decongestive treatment program, Balance exercises
- Keywords
- BOSU Ball, Lymphedema, Balance
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete decongestive treatment programProcedure or surgery
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 exercisesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Complete decongestive treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks after the start of rehabilitation
Secondary outcomes (16)
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
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.
Measured: 1 day before rehabilitation
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.
Measured: 3 weeks after the start of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oya Topuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oya Topuz, Pamukkale University
- Investigators
- Oya Topuz, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182046
- Sponsor's protocol ID
- PamukkaleU-Karaköseli-001
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BOSU Ball Balance Exercises Added to Complete Decongestive Treatment on Static and Dynamic Balance in Breast Cancer-associated Lymphedema.
- ClinicalTrials.gov ID
- NCT06182046
- Acronym / sponsor ID
- PamukkaleU-Karaköseli-001
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- BOSU Ball, Lymphedema, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oya TopuzUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Balance exercise with BOSU Ball added to complete decongestive treatment | Experimental | Procedure: Complete decongestive treatment program, Procedure: Balance exercisesComplete 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. |
| Active Control group: Complete decongestive treatment | Active comparator | Procedure: Complete decongestive treatment programPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Bilateral breast cancer
- Bilateral axillary lymph node dissection
- Metastatic breast cancer
- Receiving ongoing radiotherapy or chemotherapy
- Primary or bilateral lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete decongestive treatment programIt 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. | Procedure or surgery | Active Control group: Complete decongestive treatment, Intervention group: Balance exercise with BOSU Ball added to complete decongestive treatment |
| Balance exercisesThese 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 or surgery | Intervention group: Balance exercise with BOSU Ball added to complete decongestive treatment |
Primary outcome
Static balance measurements
Time frame: 1 day before rehabilitation
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.
Static balance measurements
Time frame: 3 weeks after the start of rehabilitation
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.
Dynamic balance measurements
Time frame: 1 day before rehabilitation
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.
Dynamic balance measurements
Time frame: 3 weeks after the start of rehabilitation
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.
16 secondary outcomes
Arm circumference measurements
Time frame: 1 day before rehabilitation
Arm circumference measurements
Time frame: 3 weeks after the start of rehabilitation
Arm volumetric measurements
Time frame: 1 day before rehabilitation
Arm volumetric measurements
Time frame: 3 weeks after the start of rehabilitation
Fall Activity Scale
Time frame: 1 day before rehabilitation
Fall Activity Scale
Time frame: 3 weeks after the start of rehabilitation
Tampa Kinesiophobia Scale
Time frame: 1 day before rehabilitation
Tampa Kinesiophobia Scale
Time frame: 3 weeks after the start of rehabilitation
Fullerton Advanced Balance Scale
Time frame: 1 day before rehabilitation
Fullerton Advanced Balance Scale
Time frame: 3 weeks after the start of rehabilitation
Timed Up and Go Test
Time frame: 1 day before rehabilitation
Timed Up and Go Test
Time frame: 3 weeks after the start of rehabilitation
Quality of Life Measurement ULL-27
Time frame: 1 day before rehabilitation
Quality of Life Measurement ULL-27
Time frame: 3 weeks after the start of rehabilitation
Hospital Anxiety and Depression Scale
Time frame: 1 day before rehabilitation
Hospital Anxiety and Depression Scale
Time frame: 3 weeks after the start of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oya Topuz study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing Complete decongestive treatment program and Balance exercises in people with Breast Cancer Related Lymphedema, run by Oya Topuz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Karaköseli (+905395765952, esra.karakoseli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance measurements (time frame: 1 day before rehabilitation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.