Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
2020年10月6日 更新者：Qing Shu、Wuhan University
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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Hubei
-
Wuhan、Hubei、中国、430070
- Zhongnan Hospital of Wuhan University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
25年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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. |
|
実験的：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.
|
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. |
|
実験的：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.
|
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. |
|
実験的：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.
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Constant-Murley Shoulder Score
時間枠：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.
|
1 weeks after surgery
|
|
Constant-Murley Shoulder Score
時間枠：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 weeks after surgery
|
|
Constant-Murley Shoulder Score
時間枠：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.
|
6 weeks after surgery
|
|
Constant-Murley Shoulder Score
時間枠：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.
|
9 weeks after surgery
|
|
Constant-Murley Shoulder Score
時間枠：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.
|
12 weeks after surgery
|
|
Constant-Murley Shoulder Score
時間枠：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.
|
18 weeks after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Active and passive range of motion
時間枠：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.
|
3 days，1, 2, 3, 6, and 9 weeks after surgery
|
|
Shoulder joint muscle strength
時間枠：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".
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3 days, 3, 6, 9 weeks after surgery
|
|
The power of gripping
時間枠：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.
|
1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
|
|
EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
時間枠：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.
|
1, 3, 9, 12, 18 weeks after surgery
|
|
SF-36 Health status questionnaire
時間枠：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.
|
1, 3, 9, 12, 18 weeks after surgery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual Analogue Scale （VAS)
時間枠：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.
|
1 day, 3 days, 1 week, 2 weeks after surgery
|
|
Sum drainage from chest wall and axillary after operation.
時間枠：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.
|
1 day, 3 days, 1 week, 2 weeks after surgery
|
|
Upper limb circumference
時間枠：Preoperative 3, 9, 12,18 weeks after surgery
|
Preoperative 3, 9, 12,18 weeks after surgery
|
|
|
body weight
時間枠：Preoperative, 3, 9 weeks after surgery
|
Preoperative, 3, 9 weeks after surgery
|
協力者と研究者
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スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年9月10日
一次修了 (実際)
2020年5月31日
研究の完了 (実際)
2020年5月31日
試験登録日
最初に提出
2018年8月29日
QC基準を満たした最初の提出物
2018年8月31日
最初の投稿 (実際)
2018年9月5日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月8日
QC基準を満たした最後の更新が送信されました
2020年10月6日
最終確認日
2020年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CRE2018013
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
About six months after the trial complete
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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