Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
NCT ID: NCT03658265
Last Updated: 2020-10-08
Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2018-09-10
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 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
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
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
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
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
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
75 Years
FEMALE
No
Sponsors
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Wuhan University
OTHER
Responsible Party
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Qing Shu
Principal Investigator
Locations
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Zhongnan hospital of Wuhan University
Wuhan, Hubei, China
Countries
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References
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Shu Q, Yang Y, Shao Y, Teng H, Liao R, Li Z, Wu G, Hou J, Tian J. Comparison of Rehabilitation Training at Different Timepoints to Restore Shoulder Function in Patients With Breast Cancer After Lymph Node Dissection: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):728-737. doi: 10.1016/j.apmr.2023.01.021. Epub 2023 Feb 20.
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.
Other Identifiers
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CRE2018013
Identifier Type: -
Identifier Source: org_study_id
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