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Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery (EMOVE-BCS)

2026년 6월 11일 업데이트: Marta Aguilar-Rodriguez

Evaluation of the Safety, Feasibility, and Functional Outcomes of a Structured Early Rehabilitation Protocol Following Breast Cancer Surgery: A Prospective Study in Routine Clinical Practice.

Breast cancer is one of the most common tumours in women. Advances in diagnosis and treatment have increased survival, but many women experience functional sequelae after breast and/or axillary surgery, including pain, reduced shoulder range of motion, loss of strength, difficulties in daily activities, axillary web syndrome, and possible lymphoedema. These impairments may affect autonomy, self-care, return to daily life, and correct arm positioning during adjuvant treatments such as radiotherapy.

Although therapeutic exercise and rehabilitation are recommended within oncology care, the implementation of early rehabilitation programmes after breast cancer surgery remains variable. This study aims to evaluate a structured, individualised, and supervised early rehabilitation protocol, EMOVE-BCS-LaFe, applied in routine clinical practice during the first three months after surgery.

The main hypothesis is that the protocol is safe and feasible, with a low frequency of physiotherapy-related adverse events requiring urgent care or programme suspension for more than 7 days, and high completion and adherence rates. Secondary outcomes include improvements in shoulder mobility, pain, upper limb function, strength, overall functional capacity, satisfaction, and differences according to type of breast and axillary surgery.

A prospective, single-centre, observational, single-arm cohort study will be conducted at HUIP La Fe. Adult women undergoing breast cancer surgery and referred to the programme will be consecutively included. The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based and supervised sessions, individualised progression, self-care recommendations, and early detection and management of axillary web syndrome and lymphoedema.

Follow-up will extend from preoperative assessment to three months after surgery. Safety, adherence, programme completion, range of motion, pain, upper limb function, shoulder strength, functional capacity, and satisfaction will be assessed using adverse event records, adherence data, goniometry, VAS, QuickDASH, dynamometry, 30-second Sit-to-Stand test, CSQ-8, and specific satisfaction items. Data analysis will be descriptive, estimating proportions, clinical-functional changes over time, and exploratory differences according to surgery type.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

110

단계

  • 해당 없음

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Women aged ≥18 years undergoing breast cancer surgery at Hospital Universitari i Politècnic La Fe and referred to the early postoperative rehabilitation programme through the usual care pathway.
  • Any type of breast surgery, including breast-conserving surgery and/or mastectomy, with or without reconstruction/prosthesis, and bilateral surgery.
  • Any type of axillary surgery, including sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND).
  • Patients undergoing surgery for recurrence and/or reoperation, for example margin widening, reoperation due to complications, or reoperation for oncological reasons, provided that it is clinically possible to start the programme.
  • Ability to understand instructions, complete questionnaires, and sign the informed consent form.-

Exclusion Criteria:

  • Inability to safely start the protocol during the first postoperative weeks due to medical or surgical contraindication, or due to severe clinical complications, for example the need for strict immobilization, specific restrictions, or prolonged hospital admission, according to the criteria of the surgical team or the rehabilitation service, preventing the protocol from being initiated according to the usual care schedule.
  • Severe pre-existing upper limb condition, unilateral or bilateral, causing significant limitation of mobility or function before surgery and making the interpretation of clinical progression unreliable, for example shoulder arthroplasty, recent fracture, frozen shoulder in the inflammatory phase with severe limitation, or untreated massive rotator cuff tear with marked functional impairment.
  • Severe neurological or musculoskeletal disease that significantly affects upper limb function and may influence the main outcome variables, for example stroke with major sequelae, spinal cord injury, or severe neuropathy.
  • Cognitive impairment, severe decompensated psychiatric disorder, or language barrier without available support, preventing the participant from understanding instructions and completing assessments.
  • Participation in another study that may substantially interfere with the results, according to the investigator's judgment.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Early rehabilitation protocol
Participants assigned to this single study arm will receive the structured EMOVE-BCS-LaFe early postoperative rehabilitation protocol after breast cancer surgery. The protocol includes preoperative education, therapeutic exercise initiated from the first postoperative day, individualized phase-based progression, self-care recommendations, monitoring of physiotherapy-related adverse events, adherence recording, and early detection and management of axillary web syndrome and lymphedema during the three-month postoperative follow-up.
절차: Early Postoperative Rehabilitation Protocol
A structured, individualized, phase-based early postoperative rehabilitation protocol after breast cancer surgery. The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based exercise with adherence monitoring, supervised progression according to breast and axillary surgery type, self-care recommendations, and early detection and management of axillary web syndrome and lymphedema. The protocol is delivered as part of routine clinical practice and followed for three months after surgery.
다른 이름들:
  • EMOVE-BCS-LaFe
  • Early Rehabilitation After Breast Cancer Surgery

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Physiotherapy-related adverse events
기간: From Day 1 after surgery up to 3 months after surgery
Percentage of participants with at least one physiotherapy-related adverse event requiring urgent medical care and/or suspension of the rehabilitation protocol for more than 7 days. Adverse events will be prospectively recorded at each postoperative visit and through review of the medical record.
From Day 1 after surgery up to 3 months after surgery
Protocol completion rate
기간: At the end of the protocol, at three months after surgery
Percentage of participants who complete the 3-month follow-up assessment and the early postoperative rehabilitation protocol. Reasons for non-completion will also be recorded.
At the end of the protocol, at three months after surgery
Adherence to the home-based exercise program
기간: From Day 1 after surgery up to 3 months after surgery
Percentage of participants who adhere to the home-based exercise program, defined as performing the prescribed exercises at least 4 days per week. Adherence will also be recorded as the mean number of exercise days per week
From Day 1 after surgery up to 3 months after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Shoulder range of motion
기간: Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Active shoulder flexion, abduction and rotation range of motion will be measured in degrees using standardized goniometry. Changes from baseline to the final 3-month assessment will be described.
Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Postoperative pain
기간: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Postoperative pain intensity will be assessed using a 0-10 visual analogue scale (VAS) where higher scores indicate greater pain. Changes in pain intensity will be assessed during postoperative follow-up.
1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Incidence of Axillary web syndrome
기간: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Percentage of participants who develop axillary web syndrome during postoperative follow-up, assessed by clinical examination based on the presence or absence of visible or palpable axillary cords.
1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Persistence of axillary web syndrome at 3 months
기간: 3 months after surgery
Percentage of participants with axillary web syndrome still present at the final follow-up visit, assessed by clinical examination based on the presence or absence of visible or palpable axillary cords.
3 months after surgery
Upper limb function
기간: Baseline and 3 months after surgery
Upper limb function will be assessed using the Spanish version of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability and worse upper limb function. Changes from baseline to the 3-month assessment will be evaluated.
Baseline and 3 months after surgery
Shoulder strength
기간: Baseline and 3 months after surgery
Shoulder strength will be assessed in kilograms using a handheld dynamometer according to a standardized protocol. The mean value of three attempts will be recorded. Changes from baseline to the 3-month assessment will be evaluated.
Baseline and 3 months after surgery
Overall functional capacity
기간: Baseline and 3 months after surgery
Overall functional capacity will be assessed using the 30-second Sit-to-Stand test. Changes in the number of repetitions from baseline to the final assessment will be described.
Baseline and 3 months after surgery
Early detection of lymphedema
기간: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Percentage of participants with suspected lymphedema during postoperative follow-up. Suspected lymphedema will be recorded as present or absent based on clinical assessment and comparison between upper limbs according to routine clinical practice.
1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Handgrip strength
기간: Baseline and 3 months after surgery
Handgrip strength will be assessed using a hand dynamometer according to a standardized protocol. Changes from baseline to the final 3-month assessment will be described.
Baseline and 3 months after surgery
Patient satisfaction
기간: At 3 months after surgery
Patient satisfaction with physiotherapy care will be assessed using the Spanish version of the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. Additional protocol-specific satisfaction items will be reported descriptively.
At 3 months after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Marta Aguilar-Rodriguez

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 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 6일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

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기타 연구 ID 번호

  • 26.04.2026

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