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

Not Applicable

Completed

• Conditions: Shoulder Dysfunction; Breast Cancer; Modified Radical Mastectomy
• Interventions: Other: 3 days SIE plus 3 weeks PRE; Other: 7 days SIE plus 4 weeks PRE; Other: 7 days SIE plus 3 weeks PRE; Other: 3 days SIE plus 4 weeks PRE

• Registration Number: NCT03658265
• Lead Sponsor: Wuhan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Study Start: 2018-09-10
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 days SIE plus 3 weeks PRE	3 days SIE plus 3 weeks PRE	Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
7 days SIE plus 4 weeks PRE	7 days SIE plus 4 weeks PRE	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	7 days SIE plus 3 weeks PRE	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	3 days SIE plus 4 weeks PRE	Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.

Primary Outcome Measures

Name	Time	Method
Constant-Murley Shoulder Score	18 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 Outcome Measures

Name	Time	Method
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.
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".
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.
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.

Trial Locations

Locations (1)

Zhongnan hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China