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Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.
Study subjects:
Result variable:
Primary outcome variable:
1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
Secondary outcome variables:
Assessment Schedule:
Number of study subjects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling. |
|
| Control group | No Intervention | One session of flexibility exercise education, diet management education through nutritional counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise, Strength training, Flexibility exercise | Behavioral | Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement
|
| Measure | Description | Time Frame |
|---|---|---|
| Bilateral upper limb volume | Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb. | Immediately, Preoperatively, 1 month, 3 months, 6 months. |
| ICG lymphography | Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera. | Immediately, 1 month, 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | After attaching electrodes to both hands and feet using the Inbody S10 equipment, quantitatively evaluate body composition by measuring human body impedance using multiple frequencies. | Immediately, 6 months. |
| Shoulder range of motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaeyong Jeon | Contact | +82-2-3010-3791 | jyjeon71@gmail.com | |
| Seungwoo Cha | Contact | +82-2-3010-3799 | miracleofs@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jaeyong Jeon | Asan Medical Center | Principal Investigator |
| Heejeong Kim | Asan Medical Center | Study Chair |
| Seungwoo Cha |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Asan Medical Center | Recruiting | Seoul | Seoul Special City | 05505 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Measurements are made according to a standardized protocol using a goniometer. |
| Immediately, Preoperatively, 1 month, 3 months, 6 months. |
| Upper limb strength, grip strength | Using a digital hand held dynamometer, the strength of elbow flexion and extension, shoulder abduction, and flexor extensor muscles was measured. Measure grip strength using a digital hand held dynamometer | Immediately, 6 months |
| EORTC QLQ-C30 | Evaluate the patient's quality of life through the corresponding questionnaire | Immediately, 6 months |
| EORTC QLQ-BR23 | Evaluate the patient's quality of life through the corresponding questionnaire | Immediately, 6 months |
| Asan Medical Center |
| Study Chair |
| Chul Jung | Asan Medical Center | Study Chair |
| Hwayeong Cheon | Asan Medical Center | Study Chair |
| Junghwa Do | Asan Medical Center | Study Chair |
| Woojin Jeong | Asan Medical Center | Study Chair |
| Doyoung Kim | Asan Medical Center | Study Chair |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |