Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Specific Exercise Therapy

    Behavioral

    The 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

140 Participants
are divided into 2 treatment groups
Group A: Early Initiation of Specific Exercise TherapyExperimental treatment 1 intervention
Group B: Delayed Initiation of Specific Exercise TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed preoperatively (baseline) and at 6 months postoperative.

Secondary outcomes

1

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.

Time frame
Assessed at baseline and at 1, 3, and 6 months postoperative.
2

Wound-Related Complications - Drainage Time (Days)

The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications.

Time frame
Monitored during the immediate postoperative period up to 3 months.
3

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.

Time frame
Monitored during the immediate postoperative period up to 3 months.

Other outcomes

Sponsors and contacts

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