Clinical trial NCT03658265: Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
Official title: Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dysfunction
Breast Cancer
Modified Radical Mastectomy
Keywords: breast cancer modified radical mastectomy
shoulder dysfunction
Rehabilitation Training
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Constant-Murley Shoulder Score
timeFrame: 1 weeks after surgery
measure: Constant-Murley Shoulder Score
timeFrame: 3 weeks after surgery
measure: Constant-Murley Shoulder Score
timeFrame: 6 weeks after surgery
measure: Constant-Murley Shoulder Score
timeFrame: 9 weeks after surgery
measure: Constant-Murley Shoulder Score
timeFrame: 12 weeks after surgery
measure: Constant-Murley Shoulder Score
timeFrame: 18 weeks after surgery
Secondary outcomes:
measure: Active and passive range of motion
timeFrame: 3 days，1, 2, 3, 6, and 9 weeks after surgery
measure: Shoulder joint muscle strength
timeFrame: 3 days, 3, 6, 9 weeks after surgery
measure: The power of gripping
timeFrame: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
measure: EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
timeFrame: 1, 3, 9, 12, 18 weeks after surgery
measure: SF-36 Health status questionnaire
timeFrame: 1, 3, 9, 12, 18 weeks after surgery
Other outcomes:
measure: Visual Analogue Scale （VAS)
timeFrame: 1 day, 3 days, 1 week, 2 weeks after surgery
measure: Sum drainage from chest wall and axillary after operation.
timeFrame: 1 day, 3 days, 1 week, 2 weeks after surgery
measure: Upper limb circumference
timeFrame: Preoperative 3, 9, 12,18 weeks after surgery
measure: body weight
timeFrame: Preoperative, 3, 9 weeks after surgery
Locations:
city: Wuhan
country: China
facility: Zhongnan hospital of Wuhan University
state: Hubei
Study officials:
References:
citation: 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.