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

Al Hayah University In Cairo140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Breast Cancer

Interventions

Specific Exercise Therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Willing and able to attend scheduled physiotherapy sessions and follow-up evaluations. Exclusion Criteria: * 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. * Inability to understand or complete study materials in English. * Pregnancy or lactation.

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.

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

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.

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

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.

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.