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

2020년 10월 6일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

25년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: 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.
실험적: 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.
다른: 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.
실험적: 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.
다른: 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.
실험적: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Constant-Murley Shoulder Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Active and passive range of motion
기간: 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
기간: 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 days, 3, 6, 9 weeks after surgery
The power of gripping
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Visual Analogue Scale （VAS)
기간: 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.
기간: 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
기간: Preoperative 3, 9, 12,18 weeks after surgery
Preoperative 3, 9, 12,18 weeks after surgery
body weight
기간: Preoperative, 3, 9 weeks after surgery
Preoperative, 3, 9 weeks after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wuhan University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 9월 10일

기본 완료 (실제)

2020년 5월 31일

연구 완료 (실제)

2020년 5월 31일

연구 등록 날짜

최초 제출

2018년 8월 29일

QC 기준을 충족하는 최초 제출

2018년 8월 31일

처음 게시됨 (실제)

2018년 9월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 10월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 10월 6일

마지막으로 확인됨

2020년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CRE2018013

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

About six months after the trial complete

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Tunisia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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