Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial

Conditions
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Shoulder Dysfunction, Breast Cancer, Modified Radical Mastectomy

Intervention / Treatment
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* Other: 7 days SIE plus 4 weeks PRE
* Other: 7 days SIE plus 3 weeks PRE
* Other: 3 days SIE plus 4 weeks PRE
* Other: 3 days SIE plus 3 weeks PRE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 25 and 75 years; Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks; 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; Postoperative chemotherapy or radiation therapy according to the condition; No other malignant tumors within 5 years; No physical therapy related contraindications; Signing informed consent. Exclusion Criteria: The result of SLNB is negative who did not receive ALND; Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.); Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.); Combined severe heart disease, cerebrovascular disease, and mental illness; Patients with shoulder joint dysfunction before surgery; Unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7 days SIE plus 4 weeks PRE<br>Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery. | Other: 7 days SIE plus 4 weeks PRE<br>* 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.<br>|
| Experimental: 7 days SIE plus 3 weeks PRE<br>Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery. | Other: 7 days SIE plus 3 weeks PRE<br>* 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.<br>|
| Experimental: 3 days SIE plus 4 weeks PRE<br>Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery. | Other: 3 days SIE plus 4 weeks PRE<br>* 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.<br>|
| Experimental: 3 days SIE plus 3 weeks PRE<br>Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery. | Other: 3 days SIE plus 3 weeks PRE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 18 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer modified radical mastectomy, shoulder dysfunction, Rehabilitation Training