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

11. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

110

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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.
Andere Namen:
  • EMOVE-BCS-LaFe
  • Early Rehabilitation After Breast Cancer Surgery

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physiotherapy-related adverse events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Shoulder range of motion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Marta Aguilar-Rodriguez

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

6. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 26.04.2026

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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