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

NCT ID: NCT06918184

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Early Initiation of Specific Exercise Therapy

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.

Group Type EXPERIMENTAL

Specific Exercise Therapy

Intervention Type 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

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.

Group Type EXPERIMENTAL

Specific Exercise Therapy

Intervention Type 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.

Interventions

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Specific Exercise Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al Hayah University In Cairo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Physical Therapy, Al Hayah University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed ElMeligie, Ph.D

Role: CONTACT

01159880001 ext. +20

Facility Contacts

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Mohamed ElMeligie, Ph.D

Role: primary

01159880001 ext. +20

Other Identifiers

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BCExTiming2025-02

Identifier Type: -

Identifier Source: org_study_id

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