Breast Cancer, Modified Radical Mastectomy, Shoulder Dysfunction
Conditions
Keywords
breast cancer modified radical mastectomy, shoulder dysfunction, Rehabilitation Training
Brief summary
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.
Interventions
OTHER7 days SIE plus 4 weeks PRE
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.
OTHER7 days SIE plus 3 weeks PRE
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.
OTHER3 days SIE plus 4 weeks PRE
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.
OTHER3 days SIE plus 3 weeks PRE
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.
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 25 and 75 years; 2. Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks; 3. Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy; 4. Postoperative chemotherapy or radiation therapy according to the condition; 5. No other malignant tumors within 5 years; 6. No physical therapy related contraindications; 7. Signing informed consent.
Exclusion criteria
1. The result of SLNB is negative who did not receive ALND; 2. Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.); 3. Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.); 4. Combined severe heart disease, cerebrovascular disease, and mental illness; 5. Patients with shoulder joint dysfunction before surgery; 6. Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Shoulder Score | 1 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder joint muscle strength | 3 days, 3, 6, 9 weeks after surgery | 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. |
| Active and passive range of motion | 3 days，1, 2, 3, 6, and 9 weeks after surgery | 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. |
| The power of gripping | 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery | In the standard position, the grip of the patient's palm is measured using a dynamometer. |
| EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire | 1, 3, 9, 12, 18 weeks after surgery | 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. |
| SF-36 Health status questionnaire | 1, 3, 9, 12, 18 weeks after surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Upper limb circumference | Preoperative 3, 9, 12,18 weeks after surgery | — |
| body weight | Preoperative, 3, 9 weeks after surgery | — |
| Sum drainage from chest wall and axillary after operation. | 1 day, 3 days, 1 week, 2 weeks after surgery | 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. |
| Visual Analogue Scale （VAS) | 1 day, 3 days, 1 week, 2 weeks after surgery | 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. |
Countries
China
Outcome results
None listed