About this trial
This single-center, parallel-group randomized controlled trial (RCT) will compare two timings for initiating specific exercise therapy after breast cancer surgery. The study tests whether early initiation (within the first postoperative week) versus delayed initiation (at 3 weeks postoperative) results in superior upper limb function at 6 months as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcomes include pain intensity (Visual Analog Scale, VAS) and wound-related complications such as drainage time and hematoma incidence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18-65 years.
Scheduled to undergo breast cancer surgery with axillary node dissection.
At risk for upper limb morbidity based on preoperative assessment.
Able to provide informed consent and complete study questionnaires.
Disqualifiers
Diagnosis of recurrent or metastatic breast cancer.
Concurrent participation in another rehabilitation intervention or clinical trial.
Severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic conditions) that preclude safe participation.
History of previous shoulder surgery or chronic upper extremity musculoskeletal disorders unrelated to breast cancer treatment.
Trial design
Parallel
Treatments tested in this trial
Specific Exercise Therapy
BehavioralThe exercise protocol includes mobilisation and stretching with 40-minute sessions twice weekly for 8 weeks post-initiation, transitioning to a home-based maintenance phase for 4 months. All sessions will be supervised by certified physiotherapists.
Treatment groups
Trial outcomes
Primary outcomes
Upper Limb Function (DASH Questionnaire)
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated measure of upper limb function. The questionnaire is scored on a continuous scale ranging from 0 to 100, where 0 indicates no disability and 100 represents the most severe disability. Lower scores indicate better upper limb function.
Secondary outcomes
Pain Intensity (Visual Analog Scale - VAS)
A 0-100 VAS will measure patient-reported pain levels, where 0 signifies no pain and 100 the worst pain imaginable.
Wound-Related Complications - Drainage Time (Days)
The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications.
Wound-Related Complications - Incidence of Hematoma
The occurrence of hematoma will be documented as a binary outcome (presence or absence) for each patient. The incidence will be calculated as the proportion of patients developing hematoma during the monitoring period.
Sponsors and contacts
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