Skip to main content
OpenTrials
Completed

NCT Number: NCT03658265

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Dysfunction Breast Cancer Breast Diseases Breast Neoplasms Modified Radical Mastectomy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan hospital of Wuhan University

Wuhan, Hubei, 430070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 25 and 75 years;
  • Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
  • 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;
  • Postoperative chemotherapy or radiation therapy according to the condition;
  • No other malignant tumors within 5 years;
  • No physical therapy related contraindications;
  • Signing informed consent.

Exclusion criteria

  • The result of SLNB is negative who did not receive ALND;
  • Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
  • Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
  • Combined severe heart disease, cerebrovascular disease, and mental illness;
  • Patients with shoulder joint dysfunction before surgery;
  • Unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Treatment and study plan

7 days SIE plus 4 weeks PRE

Other

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

Other

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

Other

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

Other

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.

Primary outcomes

  1. Constant-Murley Shoulder Score

    Time frame: 1 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.

  2. Constant-Murley Shoulder Score

    Time frame: 3 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.

  3. Constant-Murley Shoulder Score

    Time frame: 6 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.

  4. Constant-Murley Shoulder Score

    Time frame: 9 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.

  5. Constant-Murley Shoulder Score

    Time frame: 12 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.

  6. Constant-Murley Shoulder Score

    Time frame: 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 outcomes

  1. Active and passive range of motion

    Time frame: 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.

  2. Shoulder joint muscle strength

    Time frame: 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".

  3. The power of gripping

    Time frame: 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.

  4. EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire

    Time frame: 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.

  5. SF-36 Health status questionnaire

    Time frame: 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.

Other outcomes

  1. Visual Analogue Scale （VAS)

    Time frame: 1 day, 3 days, 1 week, 2 weeks after surgery

    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.

  2. Sum drainage from chest wall and axillary after operation.

    Time frame: 1 day, 3 days, 1 week, 2 weeks after surgery

    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.

  3. Upper limb circumference

    Time frame: Preoperative 3, 9, 12,18 weeks after surgery

  4. body weight

    Time frame: Preoperative, 3, 9 weeks after surgery

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.