Exercise Prehabilitation of Breast Cancer (Prehab of BC)

The Impact of Exercise Prehabilitation on Upper Extremity Range of Motions, Functionality and Quality of Life in Breast Cancer Survivors: A Prospective Clinical Trial

This prospective prehabilitation trial evaluated the effectiveness of an individualized exercise program initiated before breast cancer surgery and maintained for 12 months. The intervention aimed to promote functional recovery and improve patient-reported outcomes.

Study Overview

Detailed Description

Women scheduled for breast surgery due to breast cancer were enrolled in an individualized prehabilitation program that began in the preoperative period and continued for 12 months. The exercise program included range-of-motion, strengthening, and postural correction exercises delivered through supervised and home-based sessions. Outcomes were evaluated at baseline and at 1st, 3rd, 6th, and 12th months. Functional outcomes, shoulder range of motion, pain intensity, lymphedema development, and patient-reported quality of life were assessed.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Balıkesir, Turkey (Türkiye)
        • Balikesir Ataturk City Hospital Affiliated with University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients diagnosed with breast cancer scheduled for surgical treatment
  • Age ≥ 18 years
  • Able to perform exercise
  • Provided informed consent

Exclusion Criteria:

  • Metastatic disease
  • Prior upper limb injury or neurologic impairment
  • Inability to comply with exercise program
  • Postoperative chemotherapy before the 3rd month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Group Assignment

The exercise program was delivered to patients through both visual and written materials, accompanied by face-to-face training sessions conducted by a physiotherapist. A home-based program was designed separately for the pre-surgery phase, postoperative day 1, day 3, day 7, and the maintenance period.

The exercise template included postural correction, breathing, aerobic, stretching, and resistive strengthening exercises targeting muscles in adjacent to the shoulder joint and mobilization of scapulothoracic complex via stretching and strengthening exercises of periscapular muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Range of Motion
Time Frame: baseline, 1st-3rd-6th-12th month
Measurement of Flexion, Abduction, Internal and External Rotation of Shoulder with goniometer
baseline, 1st-3rd-6th-12th month
Pain Intensity
Time Frame: baseline, 1st-3rd-6th-12th month
measure of pain with VAS (Visual analog scale)
baseline, 1st-3rd-6th-12th month
Functional Outcomes
Time Frame: baseline and 12th month
measure of upper extremity functions with UEFI-15 (Upper extremity functional index) instrument
baseline and 12th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue
Time Frame: baseline and 12th month
measure of fatigue condition with FSS (Fatigue severity scale) instrument
baseline and 12th month
Quality of Life impairment
Time Frame: baseline and 12th month
measure of Quality of Life with EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire) instrument
baseline and 12th month
lymphedema
Time Frame: baseline and 12th month
Limb volume difference >10% or clinical signs of edema
baseline and 12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Actual)

November 2, 2025

Study Completion (Actual)

November 2, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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