Breast Cancer FemaleEMOVE-BCSNCT07651696
Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery
A study testing Early Postoperative Rehabilitation Protocol in people with Breast Cancer Female, run by Marta Aguilar-Rodriguez.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Early Postoperative Rehabilitation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer Female
- Being tested
- Early Postoperative Rehabilitation Protocol
- Keywords
- Breast cancer surgery, Postoperative rehabilitation, Early rehabilitation, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Postoperative Rehabilitation ProtocolProcedure or surgery
Also called EMOVE-BCS-LaFe, Early Rehabilitation After Breast Cancer Surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early rehabilitation protocol | Experimental | 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. Receives: Procedure: Early Postoperative Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiotherapy-related adverse events
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.
Measured: From Day 1 after surgery up to 3 months after surgery
Protocol completion rate
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.
Measured: At the end of the protocol, at three months after surgery
Adherence to the home-based exercise program
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
Measured: From Day 1 after surgery up to 3 months after surgery
Secondary outcomes (10)
Shoulder range of motion
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.
Measured: Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Postoperative pain
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.
Measured: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Incidence of Axillary web syndrome
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.
Measured: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Persistence of axillary web syndrome at 3 months
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.
Measured: 3 months after surgery
Upper limb function
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.
Measured: Baseline and 3 months after surgery
Shoulder strength
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.
Measured: Baseline and 3 months after surgery
Overall functional capacity
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.
Measured: Baseline and 3 months after surgery
Early detection of lymphedema
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.
Measured: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Handgrip strength
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.
Measured: Baseline and 3 months after surgery
Patient satisfaction
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.
Measured: At 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-group study with no control group. All participants will receive the structured EMOVE-BCS-LaFe early rehabilitation protocol after breast cancer surgery, integrated into routine clinical practice. The study does not include randomization or comparison between groups. The aim is to assess the safety and feasibility of the protocol during the three months following surgery, and to describe changes in clinical and functional outcomes, including shoulder range of motion, pain, upper limb function, strength, overall functional capacity, axillary web syndrome, adherence, and satisfaction.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marta Aguilar-Rodriguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Aguilar-Rodriguez, Fundacion Para La Investigacion Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651696
- Sponsor's protocol ID
- 26.04.2026
- Acronym
- EMOVE-BCS
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07651696
- Acronym / sponsor ID
- EMOVE-BCS / 26.04.2026
- Conditions
- Breast Cancer Female
- Keywords
- Breast cancer surgery, Postoperative rehabilitation, Early rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Marta Aguilar-RodriguezUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-group study with no control group. All participants will receive the structured EMOVE-BCS-LaFe early rehabilitation protocol after breast cancer surgery, integrated into routine clinical practice. The study does not include randomization or comparison between groups. The aim is to assess the safety and feasibility of the protocol during the three months following surgery, and to describe changes in clinical and functional outcomes, including shoulder range of motion, pain, upper limb function, strength, overall functional capacity, axillary web syndrome, adherence, and satisfaction.
| Arm | Type | Receives |
|---|---|---|
| Early rehabilitation protocol | Experimental | Procedure: Early Postoperative Rehabilitation ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.-
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Postoperative Rehabilitation ProtocolAlso: EMOVE-BCS-LaFe, Early Rehabilitation After Breast Cancer SurgeryA 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. | Procedure or surgery | Early rehabilitation protocol |
Primary outcome
Physiotherapy-related adverse events
Time frame: 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.
Protocol completion rate
Time frame: 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.
Adherence to the home-based exercise program
Time frame: 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
10 secondary outcomes
Shoulder range of motion
Time frame: Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Postoperative pain
Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Incidence of Axillary web syndrome
Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Persistence of axillary web syndrome at 3 months
Time frame: 3 months after surgery
Upper limb function
Time frame: Baseline and 3 months after surgery
Shoulder strength
Time frame: Baseline and 3 months after surgery
Overall functional capacity
Time frame: Baseline and 3 months after surgery
Early detection of lymphedema
Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
Handgrip strength
Time frame: Baseline and 3 months after surgery
Patient satisfaction
Time frame: At 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early Postoperative Rehabilitation Protocol in people with Breast Cancer Female, run by Marta Aguilar-Rodriguez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiotherapy-related adverse events (time frame: From Day 1 after surgery up to 3 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.