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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Modified Radical Mastectomy; Shoulder Dysfunction
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Wuhan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: shoulder dysfunction; breast cancer modified radical mastectomy; Rehabilitation Training
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CRE2018013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.
• IPD Sharing Time Frame: About six months after the trial complete
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No