Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery (EMOVE-BCS)
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
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：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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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 |
|---|---|---|
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Physiotherapy-related adverse events
時間枠：From Day 1 after surgery up to 3 months after surgery
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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.
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From Day 1 after surgery up to 3 months after surgery
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Protocol completion rate
時間枠：At the end of the protocol, at three months after surgery
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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.
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At the end of the protocol, at three months after surgery
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Adherence to the home-based exercise program
時間枠：From Day 1 after surgery up to 3 months after surgery
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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
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From Day 1 after surgery up to 3 months after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Shoulder range of motion
時間枠：Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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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.
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Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Postoperative pain
時間枠：1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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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.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Incidence of Axillary web syndrome
時間枠：1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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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.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Persistence of axillary web syndrome at 3 months
時間枠：3 months after surgery
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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.
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3 months after surgery
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Upper limb function
時間枠：Baseline and 3 months after surgery
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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.
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Baseline and 3 months after surgery
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Shoulder strength
時間枠：Baseline and 3 months after surgery
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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.
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Baseline and 3 months after surgery
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Overall functional capacity
時間枠：Baseline and 3 months after surgery
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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.
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Baseline and 3 months after surgery
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Early detection of lymphedema
時間枠：1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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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.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Handgrip strength
時間枠：Baseline and 3 months after surgery
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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.
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Baseline and 3 months after surgery
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Patient satisfaction
時間枠：At 3 months after surgery
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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.
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At 3 months after surgery
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26.04.2026
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
米国FDA規制機器製品の研究
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