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

NCT06918184 | Recruiting

• 1 other identifier: BCExTiming2025-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

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.

  Assessed preoperatively (baseline) and at 6 months postoperative.

Secondary Outcomes (3)

• Pain Intensity (Visual Analog Scale - VAS)

  Assessed at baseline and at 1, 3, and 6 months postoperative.

• Wound-Related Complications - Drainage Time (Days)

  Monitored during the immediate postoperative period up to 3 months.

• Wound-Related Complications - Incidence of Hematoma

  Monitored during the immediate postoperative period up to 3 months.

Study Arms (2)

Early Initiation of Specific Exercise Therapy

EXPERIMENTAL

In this group, participants will initiate specific exercise therapy within the first postoperative week. They will receive 40-minute supervised sessions twice weekly for 8 weeks, with a transition to a prescribed home-based maintenance program for an additional 4 months.

Behavioral: Specific Exercise Therapy

Delayed Initiation of Specific Exercise Therapy

EXPERIMENTAL

Participants in this group will begin the same specific exercise therapy protocol at 3 weeks postoperative. Otherwise, the intervention is identical to that provided to the Early Therapy group.

Behavioral: Specific Exercise Therapy

Interventions

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.

Delayed Initiation of Specific Exercise Therapy; Early Initiation of Specific Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohamed ElMeligie, Ph.D

CONTACT

01159880001; mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention timing, participants, care providers, and investigators are unblinded; however, those assessing the primary and secondary outcomes will be blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible women will be randomly assigned to either the early or delayed specific exercise therapy initiation group. The interventions will be identical aside from the timing; both groups will receive supervised exercise sessions and subsequent home maintenance.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 9, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)