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Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 days SIE plus 4 weeks PRE | Active Comparator | Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery. |
|
| 7 days SIE plus 3 weeks PRE | Experimental | Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery. |
|
| 3 days SIE plus 4 weeks PRE | Experimental | Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery. |
|
| 3 days SIE plus 3 weeks PRE | Experimental | Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 days SIE plus 4 weeks PRE | Other | Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. | 1 weeks after surgery |
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. | 3 weeks after surgery |
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. | 6 weeks after surgery |
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. | 9 weeks after surgery |
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. | 12 weeks after surgery |
| Constant-Murley Shoulder Score | The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function. |
| Measure | Description | Time Frame |
|---|---|---|
| Active and passive range of motion | In the standard position, the mobility of the shoulder flexion, extension, external rotation and internal rotation was measured by using protractor. The range of flexion is 0-180°, the range of extension is 0-180°, the range of external rotation is 0-90°, and the range of internal rotation is measured. 0-70°. The assessments will be performed in the active and passive state separately. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale （VAS) | Visual Analogue Scale（VAS): Used to assess the degree of pain. Draw a 10 cm horizontal line on the paper. One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates different degrees of pain. | 1 day, 3 days, 1 week, 2 weeks after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan hospital of Wuhan University | Wuhan | Hubei | 430070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36813015 | Derived | Shu Q, Yang Y, Shao Y, Teng H, Liao R, Li Z, Wu G, Hou J, Tian J. Comparison of Rehabilitation Training at Different Timepoints to Restore Shoulder Function in Patients With Breast Cancer After Lymph Node Dissection: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):728-737. doi: 10.1016/j.apmr.2023.01.021. Epub 2023 Feb 20. | |
| 33407753 |
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The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.
About six months after the trial complete
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2024 | |
| Reset | Sep 26, 2024 |
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|
| 7 days SIE plus 3 weeks PRE | Other | Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
| 3 days SIE plus 4 weeks PRE | Other | Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
| 3 days SIE plus 3 weeks PRE | Other | Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
| 18 weeks after surgery |
| 3 days，1, 2, 3, 6, and 9 weeks after surgery |
| Shoulder joint muscle strength | In the standard position, the muscle strength of the flexion, extension, external rotation and internal rotation of the shoulder joint were assessed according to the "manual muscle test standard". | 3 days, 3, 6, 9 weeks after surgery |
| The power of gripping | In the standard position, the grip of the patient's palm is measured using a dynamometer. | 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery |
| EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire | The quality of life assessment of breast cancer patients was evaluated by the total score of the EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life. | 1, 3, 9, 12, 18 weeks after surgery |
| SF-36 Health status questionnaire | The quality of life assessment of breast cancer patients was evaluated by the total score of the SF-36 Health status questionnaire, which ranged from 0 to 92. Higher scores indicate better quality of life. | 1, 3, 9, 12, 18 weeks after surgery |
| Sum drainage from chest wall and axillary after operation. |
The postoperative drainage was the total volume of the chest wall drainage tube and the underarm drainage tube. The volume measurement and recording in the drainage bag were observed daily by the nurse. |
| 1 day, 3 days, 1 week, 2 weeks after surgery |
| Upper limb circumference | Preoperative 3, 9, 12,18 weeks after surgery |
| body weight | Preoperative, 3, 9 weeks after surgery |
| Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2024 | Sep 26, 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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