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

11 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Altri nomi:
  • EMOVE-BCS-LaFe
  • Early Rehabilitation After Breast Cancer Surgery

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physiotherapy-related adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shoulder range of motion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Marta Aguilar-Rodriguez

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

6 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 26.04.2026

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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