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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658265
• Other study ID #: CRE2018013
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2020
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Modified Radical Mastectomy
• Shoulder Dysfunction

Intervention

Other:
• 7 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.
• 7 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.
• 3 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.
• 3 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.

Locations

Country	Name	City	State
China	Zhongnan hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Upper limb circumference		Preoperative 3, 9, 12,18 weeks after surgery
Other	body weight		Preoperative, 3, 9 weeks after surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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